FACULTY OF NURSING
ASSIGNMENT COVER PAGE
Student’s Name
Student’s ID
PARIMALA RAMACHANDRAN
STUDENT ID: 111170617267
THILAGA GUNASULAN
STUDENT ID: 111170617281
Same as above
Student’s NRIC
900514105314
800816105936
Year/Semester
Year 2/Semester 1
Lecturer’s Name
Dr. Santhna
Faculty
Faculty of Nursing
Program
Bachelor of Science (Hons) in Nursing (Post Registration)
Subject Name
Formative Assessment – Assignment 1(Weightage 40%)
Assignment Title
Research Proposal- LBBN 3206 Research 1 – Summative
No. of Page
(excluding this
42
page)
Required words
4200
Date submitted
25-10-2018
Soft copy included
Actual # of words
Due Date
Yes √
4000 -4500
25-10-2018
No
DECLARATION BY STUDENTS:
I certify that this assignment is my own work in my own words. All resources have been acknowledged and the
content has not been previously submitted for assessment to LINCOLN or elsewhere. I also confirm that I
have kept a copy of this assignment.
Signed:
:
PARIMALA RAMACHANDRAN
Signed
:
THILAGA GUNASULAN
Date: 25-10-2018
1
CONTENT
Chapter 1
1.1 Background of the study……………………………………………………………………3
1.2 Problem statement and the purpose of the study…………………………………….....4
1.3 Research aim / purpose………………………………………………..............................5
1.4.1 General research objective……………………………………………………………….6
1.4.2 Specific research objective……………………………………………………………….6
1.5 Research question……………………………………………………………....................6
1.6 Hypothesis……………………………………………………………….............................6
1.7.1 Independent variable………………………………………………………………………6
1.7.2 Dependent variable………………………………………………………………………..6
1.8.1 Justification…………………………………………………………………………………7
1.8.2 Significance…………………………………….............................................................7
1.9 Scope and limitation…………………………………………………………………………7
1.9 Definition of term……………………………………………………...............................7-9
Chapter 2: Literature review
2.1 Introduction to literature review……………………………………………………….…10
2.2 Standard of time out protocol……………………………………………………………10-11
2.3 Attitude on surgical time out checklist………………………..…………………………12-13
2.4 Practice on surgical time out checklist……………………………………………….....12-13
2.5 Theoretical frame work……………………………………………………………………13
2.6 Conceptual framework…………………………………………………………………….14
2.7 Rationale for choosing conceptual framework………………………………………….14
Chapter 3: Methodology
3.1 Introduction to methodology……………………………………….................................15
3.2 Description of the study………………………………………….....................................15
3.3 Study design and rational…………………………………………………………………..15
3.4 Population………………………………………..……………………………………………15
3.4.1 Inclusive criteria ……………………………………………………………………………16
3.4.2 Exclusive criteria ………………………………………….............................................16
3.4.3 Sampling size……………………………………………………………………………….16-17
2
3.5 Sampling method………………………………………………………………………………17
3.6 Research instrument…………………………………………………………………………..18
3.6.1 Section A……………………………………………………………………………………..18
3.6.2 Section B………………………………………..……………………………………………18
3.6.2 Section C……………………………………………………………………………………..18
3.7 pilot study………………………………………………………………………………………18-19
3.8 Data collection…………………………………………………………………………………19
Chapter 4: Plan for data analysis
4.1 Data analysis method appropriate for study design…………….....................................20
4.2 Method of data analysis………………………………………………………………………20
4.3 Data for displaying finding…………………………………………………………………….20
Chapter 5
Conclusion………………………………………………………………………………………….21
References…………………………………………………………………………………………22-23
List of appendix
Appendix 1………………………………………………………………………………………….24-37
Appendix 2 (questioner)…………………………………………………………………………..38-41
Appendix 3 (Gunt Chart)…………………………………………………………………………..42
3
Attitude and Practice of Surgical Nurses Regarding Surgical Time Out Protocols in the
Operating Room in a Government Hospital in Saudi
CHAPTER 1
INTRODUCTION
1.1.
Background of the Study
Operating rooms (ORs) used to be just complicated places, but the modern OR has changed
(Dean, 2008). No place epitomizes the complexity of health care delivery better than the OR
where there is the routine interface of heterogeneous, variously trained personnel using high
technology. The surgical "time out" in the Operating Theatres (OT) represents the last part of
the Universal Protocol and is performed in the operating room, immediately before the
planned procedure is initiated (WHO, 2008). The "time out" represents the final recapitulation
and reassurance of accurate patient identity, surgical site, and planned procedure (WHO, 2009).
A ―Time-Out‖ and must be accomplished before to the start of any invasive or consentnecessary practice (WHO, 2008/2009). It is very essential and last security stop before a
procedure is to begin (Song et al, 2013).
Client individuality must be recognized at least two identifiers, system with a chance to be
performed confirmed, tolerant position confirmed, technique location, including right side,
relevant pre-procedure medications, equipment, imaging situated (WHO, 2009; Backster et al,
2007). Furthermore confirmed, time-out ought to be archived (WHO, 2008; Dean, 2008). At
whatever approach with a hole in the arranged procedure, another time-out ought to further
support make performed (WHO, 2008).
The time out protocol is one of the important strategies to minimize the hazardous situation in
the OR (WHO, 2008/ 2009). It is important in OR and surgical ward as well as in overall hospital
to identify the patient (Song et al, 2013). By the implementation of time out protocol; the staff
will utilized the time more significantly and minimize surgical error in the OR by knowing the time
out protocol the team will work in more competent way and staff have very good level of
satisfaction. It can also minimize the duration of patient stay in hospital because of the
preventing errors.
4
1.2.
Problem Statement
The surgical operating team is understood to comprise the surgeons, anaesthesia
professionals, nurses, technicians and other operating room personnel involved in surgery
(Dean, 2008). Approximately two hundred and thirty four million surgeries performed every year
all over the world in which seven million unpleasant incidents happened (Backster et al, 2007).
Patient wellbeing is an important component of health care environment (Altpeter et al, 2007).
Death took place in 6.6% of patients, constant injury in thirty two percent, and temporary injury
in fifty two percent. Negligence expenditure due to these procedures was $1.3 billion (McQuillan
et al, 2009; Patterson, 2012). In Switzerland one million operations are carried out annually and
major complications are occurring in 3 to 20 percent of patients and mortality rate increased 0.8
to 1.5 percent (WHO, 2009).
The three main preventable surgical patient safety events which occur within the OR are (1) the
surgical wrongs (Kohn, 2000); (2) retained surgical items (RSI) (Mc Quillan et al, 2009); and (3)
surgical fires (Patterson, 2012). The incidence of all three combined may affect at most 5000
patients a year (approximately 2000 wrong surgery events, 2000 RSI, 500 surgical fires) in the
United States (Song et al, 2013). National sentinel event disclosure is disparate and depends on
state-based and regulatory agency voluntary reporting (Dean, 2008). Data on close-calls, which
are likely to be more frequent, remain sketchy. No matter the total number of events, we do
know that the number is greater than zero and therefore these are still ―never events‖.
An early evaluation of the present patient security and strategies are required to cure problem
inside the organization (Patterson, 2012). Health related mistake are possible during the health
care career, but through proper recognize the reason and make policy to reduce or remove
them (Song et al, 2013; Kohn et al, 2000). Surgical safety checklist can also help out to create a
successful organization that provide guarantee for the patient wellbeing (WHO, 2008).
1.3.
Research Aim/Purpose
The aim of this study is to assess the attitude and practice of surgical team members regarding
time out protocol before surgery in operation room.
5
1.4.1
General Research Objective
This study generally hopes to determine the attitude and practice of surgical team members
regarding time out protocol before surgery in OR.
1.4.2. Specific Research Objectives:
Specifically this study hopes to:
1. To determine the level of attitude among Surgical nurses Regarding Surgical Time Out
Protocols in the in Operating Room in a Government Hospital in Saudi
2. To determine the practice of Surgical nurses Regarding Surgical Time Out Protocols in
the in Operating Room in a Government Hospital in Saudi
3. To identify the significant relationship between the attitude and practice Surgical nurses
Regarding Surgical Time Out Protocols in the in Operating Room in a Government
Hospital in Saudi
1.5
Research Questions
1. What is the level of attitude among Surgical nurses Regarding Surgical Time Out
Protocols in the in Operating Room in a Government Hospital in Saudi?
2. What is the practice of Surgical nurses Regarding Surgical Time Out Protocols in the in
Operating Room in a Government Hospital in Saudi?
3. What is the relationship between the attitudes and practice Surgical nurses Regarding
Surgical Time Out Protocols in the in Operating Room in a Government Hospital in
Saudi?
1.6
Hypothesis (H1)
There is significant relationship between the attitude and the practice among nurses regarding
time out protocol before surgery in OR.
1.7.1
Independent Variables
The independent variables in our study will be attitude and practices among nurses.
6
1.7.2
Dependent Variables
The dependent variable is the time out protocols before surgery in the OR.
1.8.1 Justification
The importance of the surgical time out, uncover the root analysis for faulty performance, and to
implement change that will lead to correct performance (WHO, 2008; Kohn et al, 2000). By
following these surgical safety guidelines the morbidity and mortality rate can be reduced and
the team will work more effectively (WHO, 2008; Patterson, 2012). The study will helps to health
care professionals to minimize surgical error, time safe stress minimize, conflict management.
1.8.2 Significance
This study is significant to the nursing research department of the government hospital that is to
be used for this study. The pool of evidences will pave new avenues for nurses in the OR.
Benefit to the hospital
The study will help the organization to implement proper time out protocols and will help the
participants to know the importance of time out (Dean, 2008; Backster et al, 2007). It is also
very important to improve attitude about time out and help me to focused and implement nursing
interventions (International Council of Nurses, 2005).
Benefit to nurses
It is very significant for the staff nurses of OR to bring the surgical time out protocol in to their
practice and developed a positive attitude (Kohn et al, 2000) towards time out protocol (WHO,
2009).
Benefit for patients
Patients do not have to have incorrect surgical procedures (Kohn et al, 2000) or to be negatively
impacted by a dysfunctional time out (WHO, 2008). Patients in the OR will have more
committed nurses to restore optimal patient care in the OR.
7
1.9 Scope and Limitations
This study will not be generalized to all nurses but only to nurses in the OT as the proposal is
limited to time out protocols. This study is also limited to nurses in Kingdom of Saudi Arabia.
Finally, only a perception in a quantitative survey is used in this study and therefore, the time
out protocols are not examined in an experimental approach.
1.10
Definition of Terms
Attitude on Time Out:
The publication of ―To Err is Human‖, worldwide awareness of medical errors has driven the
need to control it in the best possible ways (Kohn et al, 2000). Attitudes on surgical time out in
the OT has been defined as an intended act of a planned action to be completed as intended to
the process of care that may not cause harm to the patient (Dean, 2008). Attitude on surgical
time out protocol is to prevent the wrong patient, wrong side, or wrong procedure from occurring
as well as confirming that the patient is in the correct position, the proper equipment / supplies
are present, confirming drug allergies and medications administered anticipation of any possible
complications (Dean, 2008; Backster et al, 2007).
Practices on Time Out:
By implementation of the practice of the surgical time out safety checklist, the consciousness for
the operating nursing staffs and the responsibility and communication increased, which
validated the reduction in the actual operating time compared to the scheduled operating time
(WHO, 2008/2009).
Surgical Time Out in the OT:
The WHO (2009) made a specific period of surgical time out procedure that is divided into the
time of the induction of anaesthesia (sign in), the incision of the skin (time out), and the moment
when the patient leaves the operating room (sign out). In each phase, the operative nurse
completes a list of checks before it proceeding with the operation.
8
OT nurses:
A surgical nurse, also referred to as a theatre nurse or scrub nurse, specializes in preoperative
nursing skills (WHO, 2008). The OT nurse is also responsible for making sure all OT equipment
is accounted for before and after the operation (WHO, 2009).
9
CHAPTER 2: LITERATURE REVIEW
2.1
Introduction
The literatures came from search engines such as Google Scholars, Google Books, PubMed,
Journal of Emergency Medicine and ProQuest.
Search terms used are ―Attitude, practice,
surgical team, Time out, Operation‖. All the selected literatures address the OT department in a
hospital setting.
2.2 Surgical Time out Protocols
The Surgical Time Out Checklist is the understanding that different practice settings will adapt it
to their own circumstances (WHO, 2008/2009; Patterson, 2012). Each safety check has been
included based on clinical evidence or expert opinion that its inclusion will reduce the likelihood
of serious, avoidable surgical harm and that adherence to it is unlikely to introduce injury or
unmanageable cost (Song et al, 2013). The Surgical Time Out Checklist was also designed for
simplicity and brevity (WHO, 2008). Many of the individual steps are already accepted as
routine practice in facilities around the world, though they are rarely followed in their entirety
(WHO, 2009). Each surgical department must practice with the Checklist and examine how to
sensibly integrate these essential safety steps into its normal operative workflow.
The Checklist divides the operation into three phases, each corresponding to a specific time
period in the normal flow of a procedure — the period before induction of anaesthesia (Sign In),
the period after induction and before surgical incision (Time Out), and the period during or
immediately after wound closure but before removing the patient from the operating room (Sign
Out) (WHO, 2008/2009). In each phase, the Checklist coordinator must be permitted to confirm
that the team has completed its tasks before it proceeds further (WHO, 2009). As operating
teams become familiar with the steps of the Checklist, they can integrate the checks into their
familiar work patterns and verbalize their completion of each step without the explicit
intervention of the Checklist coordinator (WHO, 2008). Each team should seek to incorporate
use of the Checklist into its work with maximum efficiency and minimum disruption, while aiming
to accomplish the steps effectively.
10
Nearly all the steps will be checked verbally with the appropriate personnel to ensure that the
key actions have been performed (Alpeter et al, 2007). Therefore, during ―Sign In‖ before
induction of anaesthesia, the person coordinating the Checklist will verbally review with the
patient (when possible) that his or her identity has been confirmed, that the procedure and site
are correct and that consent for surgery has been given (Backster et al, 2007). The coordinator
will visually confirm that the operative site has been marked (if appropriate) and that a pulse
oximeter is on the patient and functioning (Dean, 2008). The coordinator will also verbally
review with the anaesthesia professional the patient’s risk of blood loss, airway difficulty and
allergic reaction and whether a full anaesthesia safety check has been completed (Alpeter et al,
2007). Ideally the surgeon will be present for ―Sign In‖, as the surgeon may have a clearer idea
of anticipated blood loss, allergies, or other complicating patient factors (Backster et al, 2007).
However, the surgeon’s presence is not essential for completing this part of the Checklist.
For ―Time Out‖, each team member will introduce him or herself by name and role (WHO,
2009). If already partway through the operative day together, the team can simply confirm that
everyone in the room is known to each other (Song et al, 2013). The team will pause
immediately prior to the skin incision to confirm out loud that they are performing the correct
operation on the correct patient and site and then verbally review with one another, in turn, the
critical elements of their plans for the operation using the Checklist questions for guidance
(Patterson, 2012). They will also confirm that prophylactic antibiotics have been administered
within the previous 60 minutes and that essential imaging is displayed, as appropriate (Mc
Quillan et al, 2009).
For the ―Sign Out‖, the team will review together the operation that was performed, completion
of sponge and instrument counts and the labeling of any surgical specimens obtained (Altpeter
et al, 2007). It will also review any equipment malfunctions or issues that need to be addressed
(Backster et al, 2007). Finally, the team will review key plans and concerns regarding
postoperative management and recovery before moving the patient from the operating room
(Dean, 2008). For the ―Sign Out‖, the team will review together the operation that was
performed, completion of sponge and instrument counts and the labeling of any surgical
specimens obtained (WHO, 2008). It will also review any equipment malfunctions or issues that
need to be addressed. Finally, the team will review key plans and concerns regarding
postoperative management and recovery before moving the patient from the operating room
(WHO, 2009).
11
2.3 Attitudes on Surgical Time Out Checklist
Attitude on surgical time out protocol is to prevent the wrong patient, wrong side, or wrong
procedure from occurring as well as confirming that the patient is in the correct position, the
proper equipment / supplies are present, confirming drug allergies and medications
administered anticipation of any possible complications (Patterson, 2012; Dean, 2008).
Recognizing there is a need for change and bringing it to the attention of others is an important
attitude (Dean, 2008; WHO, 2009). The crucial part of this stage is to determine the factors that
are against positive change or weakening our interventions (WHO, 2008). If we are successful
in identifying the factors or individuals who are hindering correct performance of the time out
then we can move forward with solutions.
2.4
Practices on Surgical Time Out Checklist
The practices of the surgical time out are conducted in every operating room case before the
first incision is made to ultimately assure patient safety and prevent surgical errors (Song et al,
2013). The practices of surgical time out can be viewed as a short meeting between all
members of the surgical team to verify that everyone is on the same page and aware of the
same concerns (Patterson, 2012). The circulator nurse is the ultimate advocate for the
conduction of the surgical time out in an effort to eliminate the possibility for sentinel events and
improve patient outcomes (WHO, 2008). The obstacle occurs when staff members are not
engaged and are participating in other activities rather than focusing on the time out (WHO,
2009).
The ultimate goal of the WHO (2008 / 2009) practices of the Surgical Time Out Safety Checklist
— and of this manual — is to help ensure that teams consistently follow a few critical safety
steps and thereby minimize the most common and avoidable risks endangering the lives and
well-being of surgical patients.
Direct observation in the operating/procedure room is the best way to understand how your
surgical teams currently interact and the processes they use (Dean, 2008). If your facility is
already using a safety checklist, observation will tell you how teams use and interact with that
checklist (Backster et al, 2007). The goal of observation is to learn what the team does, when,
and how, so that your implementation team understands what your surgical teams do well in
terms of communication and teamwork, and can identify opportunities for improvement (Altpeter
12
et al, 2007). Observation is for learning — the purpose is not to identify and punish people who
are not compliant. Watching surgical teams at work helps the implementation team better
understand the needs of the surgical teams in various parts of their facility. Observation also
helps identify opportunities for improvement and potential barriers in the physical and cultural
environment.
2.5 Theoretical framework
Using this theoretical framework in this study towards nurses in the OT of hospital Saudi Arabia
shows that nurses need to achieve about attitude and practice on surgical time out protocols
(Patterson, 2012). By making this theoretical framework is easy to figure out the importance of
the surgical time out protocols (Song et al, 2013).
Having a single person lead the surgical time out checklist process is essential framework. In
the complex setting of an operating room, any of the steps may be overlooked during the fastpaced preoperative, intraoperative, or postoperative preparations (World Health Organization,
2009). Designating a single person to confirm completion of each step of the Checklist can
ensure that safety steps are not omitted in the rush to move forward with the next phase of the
operation (World Health Organization, 2008). Until team members are familiar with the steps
involved, the Checklist coordinator will likely have to guide the team through this Checklist
process. A possible disadvantage of having a single person lead the Checklist is that an
antagonistic relationship might be established with other operating team members (Mc Quillan
et al, 2009). The Checklist coordinator can and should prevent the team from progressing to the
next phase of the operation until each step is satisfactorily addressed, but in doing so may
alienate or irritate other team members (Kohn et al, 2000). Therefore, hospitals must carefully
consider which staff member is most suitable for this role. As mentioned, for many institutions
this will be a circulating nurse, but any health professional can coordinate the Checklist process.
13
2.6 Conceptual framework
•
Attitude
•
Time Out protocols in
the OT
Practice
•
Demographic
Age
Race
Level of education
Years of OT experiences
Figure 7: Conceptual framework of hand hygiene compliancy among nurses at
Emergency Department of Saudi Arabia Hospital.
2.6 Rationale for choosing conceptual framework
The researcher uses this conceptual framework because it is easy and systematic to do the
study, independent variable from this study will be the attitude and practice on surgical safety
time out. Demographic social will be the relationship between the attitude and the practice on
surgical time out among nurses.
14
CHAPTER 3: METHODOLOGY
3.0. Introduction
This section will discuss the methods and how this study will answer the hypothesis and
objectives set.
3.1 Description of study type
A quantitative study type will be used. This is the mathematical expression of the study among
nurses using the surgical time out procedures (Polit and Beck, 2010).
3.2. Study design
Descriptive, cross – sectional and observational design will be use in this study design.
3.3 Rationale for use of selected design
Descriptive research is used to describe characteristics of a population or phenomenon being
studied (Parahoo, 2006; Burns and Grove, 2015). It does not answer questions about
how/when/why the characteristics occurred (Polit and Beck, 2010). In medical research and
social
science,
a cross-sectional
study (also
known
as
a cross-sectional
analysis,
transverse study, prevalence study) is a type of observational study that analyzes data from a
population, or a representative subset, at a specific point in time (Polit and Beck, 2010; Field,
2005).
3.4. Population
The population are nurses in OT. This is further divided into inclusion and exclusion criteria, and
the sample size.
15
3.4.1 Inclusive criteria
One of the inclusions is permanent regular staff nurse position in the OT. Nurses should be on
duty on the time of the survey data collection. Finally, OT nurses who are on hands on patient
care.
3.4.2 Exclusive criteria
First exclusion is nurse supervisory position in the OT who is not involved in patient care. Part
time staff nurses in the OT are also excluded. Finally nurses who are not on duty or on long
leaves are removed from the pooling of populations.
3.4.3 Sample size
The researcher uses Raosoft (Figure 8) as a sample size calculation.
Where:
S
= Required Sample size
X
= Z value (e.g. 1.96 for 95% confidence level)
N
= Population Size
P
= Population proportion (expressed as decimal) (assumed to be 0.5 (50%)
d
= Degree of accuracy (5%), expressed as a proportion (.05); It is margin of error
S=
1.96²x50x0.5(1-0.5)
0.05² (50-1) +1.96²x0.5(1-0.5)
=
3.84x50x0.5(0.5)
0.0025(49) +3.84x0.5(0.5)
=
192x0.25
0.1225+3.84x0.25
=
48
1.0825
16
=
44
The sample size required from the formula (Krejcie& Morgan, 1970) is 44.
Table 4
17
3.5 Sampling method
Purposive sampling (also known as judgment, selective or subjective sampling) is proposed to
be used. A purposive sampling technique is used when researcher relies on his or her own
judgment when choosing members of population to participate in the study (Parahoo, 2006).
3.6. Research instruments
The
instrument
is
a
questionnaire
that
is
self
administered.
A self-administered
questionnaire refers to a questionnaire that has been designed specifically to be completed by a
respondent without intervention of the researchers (Parahoo, 2006). The survey questionnaire is
further divided into 3 sections.
3.6.1 Section A
This is the demography section where the respondents are classified into age, race, educational
attainment, and years of clinical experience.
3.6.2 Section B
This is the attitude section. The attitude is surveyed further into 6 parts.
3.6.3 Section C
This is the practice section. The practice is surveyed further into 15 parts.
3.7 Pilot study
For pilot study in appendix 4, the reliability test used was the Cronbach’s alpha to determine if
the questionnaires were valid and reliable (Kim, 2013; Field, 2005). A pilot study was a small
scale study that tests the effectiveness and efficiency of a tool before a full scale research was
conducted (Parahoo, 2006; Burns and Grove, 2015).
18
Pilot study will be carried out on December 2018. Five staff nurses will be taken for the pilot
study. The study stool used will be a questionnaire and observation tool. If Cronbach Alpha is
>0.7, it shows that the study is acceptable and establish (Kim, 2013; Lani, 2017).
3.8 Data collection process
After research proposal get approval by Research Management of Lincoln University College,
consent for respondent also will be sought from the hospital. After that the researcher will begin
the research. Consent also will be obtained from every respondent before they answer the
questionnaire. Respondent will be oriented of the purposes and their right to withdraw. All
respondent need to answer the question uses the permanent ink pen. All the answers of
questionnaire will be safely place in envelopes to preserve private and confidentially.
3.9 Method for human protection- consent
Before doing the research study, permission will be sought from the Research Management
Centre of Lincoln University College by write the official letter. Permission from the hospital also
will be sought. According National Science Foundation (2016), the fundamental principle of
human’s subject protection is that people should not be involved in research without their
informed consent, and that subjects should not incur increased risk of harm from their research
involvement, beyond the normal risks inherent in everyday life.
However, for this research, the researcher does a written consent for each respondent and they
are allowed to withdraw and change their mind if they wish to do. Seeking consent is not
appropriate when the subject is public or when rights are being violated (National Science
Foundation, 2016).
19
CHAPTER 4: PLAN FOR DATA ANALYSIS
4.1. Data analysis method appropriate for study design.
All data collected will be analyzed using descriptive method. The data collected will be enter in
excel file and will be analyzed using IBM SPSS (Statistical Package for Social Sciences)
Version 25 (Lani, 2017).
4.2. Method of data analysis
4.3 Method for displaying findings
The method of displaying these findings, the researcher will use table for demographic social,
level attitude and practice on surgical time out in the OT. The relationship between level of
attitude and practice data displaying will use table of P-value, significant value which is < 0.05 of
the result assume that there is a relationship between the two (Kim, 2013).
20
CHAPTER 5: CONCLUSION
It is therefore concluded that studying on the relationship of a good attitude and practice on
surgical safety time out protocols are important to be found among nurses. A good attitude
reflects a good practice leading to patient safety.
21
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Philadelphia
Song, J. B., Vemana, G., Mobley, J. M., & Bhayani, S. B. (2013). The second "time-out": a
surgical safety checklist for lengthy robotic surgeries. Patient Safety In Surgery, 7(1), 16. doi:10.1186/1754-9493-7-19
World Health Organization (2009). Guidelines for Safe Surgery 2009: Safe Surgery Saves Lives
(1st ed.), WHO, Geneva
World Health Organization (2008). World Alliance for Patient Safety. Implementation Manual for
Surgical
Safety
Checklist.
1st
Edition.
Safe
Surgery
Save
Lives.
Available
http://www.who.int/patientsafety/safesurgery/tools_resources/SSSL_Manual_finalJun08.pdf
23
at
Appendix 1. Ethical committee
Please complete all SECTIONS of the form. Please append consent form(s) and information sheets and
any other materials in support of your application.
If relevant, please also append the appropriate department-specific annex.
All applicants should refer to Lincoln University College Research Ethics Guidelines document.
SECTION 1
NAME OF RESEARCHER
E-MAIL ADDRESS OF THE
RESEARCHER
TYPE OF RESEARCH /
UNDERGRADUATE PROJECT
THESIS
MASTER PROJECT / THESIS
PHD THESIS
FACULTY
PROGRAMM
TITLE OF PROJECT
START DATE
24
EXPECTED DATE OF
SUBMISSION
FUNDING AGENCY (IF
APPLICABLE)
NAME OF SUPERVISOR (S)
1.
2.
3.
SECTION 2
A. Please provide a description (Abstract) of the project using the following headings:
(Please attach a separate sheet if necessary and expand this section as necessary)
1. TITLE OF THE PROJECT
2. PURPOSE OF THE STUDY
3. PARTICIPANTS ((SAMPLING METHOD, NUMBER OF SAMPLING, INCLUSION AND EXCLUSION
CRITERIA))
4. METHODS / INSTRUMENTS FOR DATA COLLECTION((previously used and published
questionnaire is not needed to be approved. Newly created or previously used unpublished
questionnaire should be submitted for approval))
5. DATA COLLECTION PROCEDURES AND DATA ANALYSIS
B. State the variables to be studied (outline the relationship between them)
C. Mention if there is any benefit to subjects / participants of taking part in this research.
D. State the ethical issues needed to conduct the proposed research
25
SECTION 3
NO.
STATEMENT
YES
1
Will you describe the main experimental procedures to participants in
advance, so that they are informed about what to expect?
2
Will you tell participants that their participation is voluntary?
3
Will you obtain written consent for participation?
4
Will you explain to participants that refusal to participate in the research
will not affect their treatment or education (if relevant)?
5
If the research is observational, will you ask participants for their consent
to being observed?
6
Will you tell participants that they may withdraw from the research at any
time and for any reason?
7
With questionnaires, will you give participants the option of omitting
questions they do not want to answer?
8
Will you tell participants that their data will be treated with full
confidentiality and that, if published, it will not be identifiable as theirs?
9
Will you debrief participants at the end of their participation (i.e. give
them a brief explanation of the study)?
NO
If you have ticked ‘NO’ to any of Q1 – 9, please give an explanation in the box below; (indicate the
question number (e.g., Q1) and then write the explanation. Expand as necessary).
26
N/A
YES
10
Will subjects/participants be paid?
11
Is electrical or other equipment to be used with subjects/participants?
12
Are there any financial or other interests to the researcher(s) or
department arising from this study?
13
Will your project involve deliberately misleading subjects/participants in
any way?
14
Is there any realistic risk of any subjects/participants experiencing either
physical or psychological distress or discomfort? If yes, describe any
measures to avoid/minimise harm to subjects in the box below.
15
Is there any realistic risk of researchers experiencing either physical or
psychological distress or discomfort?
16
Will the project require approval by any ethics committee outside Lincoln
University College?
17
Do subjects/participants fall
into any of the following
special groups?
NO
N/A
a) Children (under 16)
b) Those aged 16-18
(see attached guidelines)
b) People with learning or
communication difficulties
c) Patients
d) People in custody
e) People engaged in illegal activities.
(e.g. drug taking)
If you answered ‘yes’ to any of questions 10-17, please provide full details in the box below (expand as
necessary).
27
SECTION 4
APPLICANT’S STATEMENT
I am familiar with the LUC and other appropriate subject-specific guidelines and have discussed them
with the other researchers involved in the project / supervisor.
I undertake to inform the Committee of any changes to the protocol or the staffing of this project
CANDIDATE / RESEARCHER:
Name: ………………..……………………… Signed: ……………………… Date: …………
SUPERVISOR:
Name: ………………..……………………… Signed: ……………………… Date: …………
Dean of Faculty/ Head of Department (or designate) statement of support (if project is to be forwarded
to the University Ethical Committee)
28
SECTION 5:
STATEMENT OF ETHICAL APPROVAL
APPLICANT
FACULTY
PROGRAMM
TITLE OF PROJECT
START DATE
EXPECTED DATE FOR
SUBMISSION
Please complete the appropriate section below:
1. This project has been considered and has been approved by the Faculty/ Department
of…………............................................. the period .20........ ./ .20........
Name: Associate Prof. Datin Hafizah Che Hassan
(Dean of Faculty/ Head of Department)
Signature: …………………..…………………………
Date………………………….………………..…..……
29
2. This project has been considered by the Centre of Post-graduate Studies, Lincoln University College
and is now recommended for approval to the LUC Ethical Committee the period .20........ ./ .20.........
Name: …………………………………………………
(Director, Centre of Post-graduate Studies, LUC)
Signature: ……………………………………...……
Date ………………………………….………….……
3. This project has been approved by Chairman of LUC Ethical committee and is approved and
authorised for the period .20........ ./ .20.........
Name: …………………………………………………
(Chairman, LUC Ethical Committee)
Signature: ……………………………………...……
Date ………………………………….………….……
30
FORM A: LUCRHSS APPLICATION FORM
LUCRHSS Reference No:
TITLE OF RESEARCH PROJECT:
GRANT. NO (if applicable):
Date:
Investigators
Name
Dept & Address
Tel/ Fax
email
Principal
Investigator/
supervisor
Human Subject Involvement (Please Tick)
1
Questionnaires / Interviews
2
Physiological Measurements
3
Clinical Trials of Drugs / Formulations
4
Clinical Trials of Devices
5
Human Genetic Research
6
Human Tissue Samples (please specify: .......…………………)
7
Body Fluids (please specify: .......…………………)
8
Others (please specify: .......…………………)
Information should be provided by applicant (12 points checklist). Indicate with a tick (√) if provided and
a cross (X) if not (if not, please state the reason(s) or state as ‘not applicable’).
In the Remarks section, you have the option to briefly describe/refer to where the information can be
found in the documents enclosed with your application (for example, if the particular itemised
information can be found in the proposal, state: please refer to proposal, methodology section, page
23).
31
No
Items
Check Remarks
list
√ or X
1
Protocol of research proposal
a) Summary of proposal
i) Purpose
Ii) Background and Rationale
iii)Hypothesis (Research Questions)
b) Methodology / Procedures
i) Procedures involve invasion of the body e.g.
touching, contact, attachment of instruments,
withdrawal of specimens) For clinical research ,
please refer to Good Clinical Practice (GCP)
ii) Description of all procedures to be
conducted in a sequential order in which
research subjects will be involved (e.g.
paper and pencil tasks, interviews, surveys,
questionnaires, physical assessment,
psychological tests, doses and methods of
administration of drugs, time requirement)
iii) A copy of questionnaires (attached)
iv) A copy of permission/approval letter
to carry out the research (attached)
2
Study population (Subjects involved in the
32
Comments by
Committee
Chairperson
study)
a) Description of how subjects are recruited into
study (selection criteria)
b) Number of Subjects
c) Gender
d) Age Range
e) Special characteristics
i) Inclusion Criteria
ii) Exclusion Criteria
f) Relationship between investigator
and subjects
g) Emolument or compensation for
participation (for subject)
3
Feedback to subjects
Provision made for arrangements to inform
subjects of the outcome of the research
4
Potential benefits of the study
a) Direct benefits to subject from involvement in
the study
b) Potential / benefits to the scientific
community / society that would justify
involvement of human subjects in the study
5
Potential risks of the study
a) Psychological risks / harm (which might
make subject demeaned, embarrassed, worried
33
or upset)
b) Physical risks
c) Social risks / harm. Loss of status, privacy and
/or reputation
d) Pharmaceutical details and known safety of
formulations used
6
Competency of Investigators in carrying out
research / Procedures
b) CVs of all research participants/supervisors
c) Investigators have experience conducting
similar research
7
Respondent’s information sheet (language
used must be appropriate to the subject’s age
and educational background)
Information a-k available to subjects (letter
of information separate from consent form):
describing disease / condition to be evaluated
in the research
The respondent’s information sheet must include
the following (please refer to Appendix C):
a) Proper translations in language understood
by respondent
b) Disease evaluated
c) Drug evaluated
d) Others
34
e) Aim of study
f) Why the subject is chosen for the research
g) Expected outcome
h) Alternative treatment available
i) Side-effects of participating in the study
j) Organization and funding of research
k) Emolument for subjects
8
Study Site
9
Study Insurance for subjects
10
Informed consent form (please refer to Appendix
C for sample consent form)
a). a) Appropriate language (language used
must be appropriate to the subject’s age and
educational background)
b) Criteria should include reading and
understanding of subject information sheet
11
Research funding and approval status
a) University
35
b) Government
c) Private/Company
d) Others
12
Vetting from other committees (Student’s
Investigator/Main
proposal must be presented to the Supervisory
Supervisor
Committee and be endorsed by the Main
Signature:
Supervisor before applying for JKEUPM approval)
Name:
a) Has the proposal been vetted by other
Date:
committees? (e.g. supervisory committees,
research committees)
b) If yes, please specify committee.
...................................................................
...................................................................
36
I) FIRST REVIEW
Comments by LUCRHSS:
Remarks:
Please tick (√)
Approved
Requires amendments
Resubmission / Rejected
Date:
II) SECOND REVIEW
Comments by LUCRHSS:
Remarks:
Please tick (√)
Approved
Requires amendments
Resubmission / Rejected
Date:
37
38
Appendix 2: QUESTIONAIRE
Introduction to Research Questionnaire
Please complete this questionnaire only if you are registered nurse providing direct patient care
in medical or surgical or cardiac catheter lab unit.
STRUCTURED QUESTIONNAIRE
Instructions:
1) Please answer all the questions as honest as possible
2) Please indicate your agreement or disagreement with the following statement
Your cooperation in filling out this questionnaire is highly appreciated. Please do no write your
name on the paper. Your confidentiality is assured.
Section A: Demographic Data
1. Age
25 – 30 years old
31 – 40 years old
41 – 50 years old
51 and above
2. Level of education
Diploma
Bachelor
Degree
Master
39
3. Race
Local Arab
Malaysian
Others
4. Years of OT experience
1-3 years
4-10 years
11-16 years
PART B: Attitude
I would like to know your attitudes towards Surgical Time Out Procedure. Answer the
following questions as truthfully as possible.
YES
C1
Do you think it is useful?
C2
Do you perceive it prevents mistakes?
C3
Do you feel that it causes delays?
C4
Do you think it does not work?
C5
Do you believe in the surgical time out procedure that it is safe?
C6
Do you feel that it is worth recommending to all nurses in the OT
40
NO
PART C: Practice
A. Practice
I would like to gather information about your practice.
Yes
D1
Do you confirm patient identity site procedure and consent?
D2
Do you mark the operating site or see where the mark is upon sign in?
D3
Do you use antiseptic to wash your hands before sign in?
D4
Do you sign in the anesthesia checklist?
D5
Do you read oxygenation of the patient using pulse oxymeter upon sign in?
D6
Do you assess patient allergic reactions upon sign in?
D7
Do you facilitate or assess airway clearances upon sign in?
D8
Do you assess risk of blood loss upon sign in?
D9
Do you confirm all team members in the OT before patient time out?
D10
Do you anticipate critical events upon patient time out in the OT?
D11
Do you assess any patient specific concern upon patient time out in the OT?
D12
Do you ensure that antibiotic prophylaxes are given upon patient time out in the
OT?
D13
Do you include sterility indicator results upon time out in the OT?
D14
Do you ensure essential imaging is secured upon patient time out in the OT?
D15
Do you sign out in the OT?
41
No
Appendix 3: TIME LINE AND GANTT CHART
YEAR
Activity Month
2017
Nov Dec
Research Proposal
Ethics Committee
Data Collection
Data Analysis and
Report
Review Research Report
with Supervisor
Prepare for FINAL
Research Presentation
FINAL Presentation of
Research
Submit Research Report
42
2018
Jan
Fab Mar Apr
May