Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05207410 |
| Other study ID # |
ILBS-UGIBCLD-100 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2021 |
| Est. completion date |
December 5, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
Institute of Liver and Biliary Sciences, India |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
A study to assess the effectiveness of teaching program for the management of upper GI
bleeding in terms of gain in nurses' practice and knowledge related to management of upper GI
bleeding among chronic liver disease patients visiting Emergency Room at ILBS, New Delhi.
The study assumes that- The nurses are practising as per their usual nursing practices while
managing the patients with upper GI bleeding.
Nursing Personnel have some knowledge in the practice related to management of upper GI
bleeding among CLD patients.
The nurses are documenting their nursing intervention correctly. The patient is managed by
the nurses through a nursing team approach. (Any nursing professional from the nursing team
can attend to the patient in the emergency room.) Structured teaching program will enhance
the patient care related to the management of upper GI bleeding among chronic liver disease
patients visiting Emergency Room.
The study hypothesis is tested at 0.05 level of significance: - H1 - There is a significant
difference between mean knowledge score of nurses' before and after administration of
Structured teaching Program as measured by Structured Questionnaire H2 - There is a
significant difference between mean practice score of nurses' before and after administration
of Structured teaching Program as measured by observation checklist H3 - There is a
significant difference between mean practice response time score of nurses' before and after
administration of Structured teaching Program as measured by observation checklist H4 - There
is a significant association between nurses' knowledge and selected demographic and clinical
variables of the patients visiting Emergency Room.
Description:
A study to assess the effectiveness of teaching program for the management of upper GI
bleeding in terms of gain in nurses' knowledge and practice related to management of GI
bleeding among chronic liver disease patients visiting Emergency Room at ILBS, New Delhi.
The objectives of the study To determine the nurses' knowledge in the management of upper GI
bleeding among chronic liver disease patients visiting Emergency Room before and after the
administration of the structured teaching programme.
To determine the nurses' practices and nurses practice response time in the management of
upper GI bleeding among chronic liver disease patients visiting Emergency Room before and
after the administration of the structured teaching programme.
To assess the factors affecting the nurses' practice in the management of upper GI bleeding
among chronic liver disease patients visiting emergency room.
To find out the association between nurses' knowledge in the management of upper GI bleeding
among chronic liver disease patients visiting emergency room and the selected demographic
variables of the nurses' working in emergency room.
Operational definition Assess: In this study it refers to evaluating the effectiveness of
nurses' practice and related factors in the management of upper GI bleeding among chronic
liver disease patients visiting Emergency Room.
Effectiveness: In this study, it refers to the power of nursing structured teaching program
to bring about the changes in the nurses' practices measured by significant gain in knowledge
score and assessed by structured knowledge questionnaire.
Nurse: In this study, it refers to the staff nurses as well as team leader on duty who are
actively involved in direct care of CLD patients visiting emergency room with upper GI
bleeding.
Practice: In this study, it refers to the performance of requisite interventions by the
nurses related to management of upper GI bleeding among chronic liver disease patients
visiting Emergency Room as measured by observation checklist.
Knowledge: In this study, it refers to the ability of nurses to respond correctly to
structured knowledge questionnaire containing knowledge items on management of upper GI
bleeding among CLD patients, as evident from knowledge scores.
Response time: In this study, it refers to the time from the arrival of the patient at
Emergency Room gate till the patient gets a response from the emergency room nursing staff in
term of implementing requisite nursing intervention(s) in the management of upper GI
bleeding.
Factors- In this study, it refers to all those elements in the emergency room and
characteristics of nurses that may influence the nurse's practice in providing quality care
to CLD patients visiting Emergency Room with upper GI bleeding and includes their age,
experience, nurse patient ratio, shift duration, emergency training, physical training,
administrative policies, education level, knowledge, length of work.
Upper GI bleeding - In this study, it refers to classic upper GI bleeding symptoms or the
history of recent upper GI bleeding for which a chronic liver disease patient visits the
emergency room of ILBS.
Management of upper GI bleeding - In this study, it refers to all nursing intervention
towards assessment of early initiation of clinical care and symptom management within the
emergency room and includes the following: -
- Primary assessment,
- Resuscitation/stabilisation,
- History collection& health assessment,
- Supportive treatment,
- Transfer and referral. Chronic liver disease - In this study, it refers to patients
diagnosed with Chronic liver disease and admitted in the emergency room for the
management of upper GI bleeding.
Patients - In this study, it refers to the person either male or female who is coming for the
management of upper GI bleeding among chronic liver disease patients visiting Emergency Room
of ILBS hospital during the time of data collection Emergency Room (ER) -In this study, it
refers to the emergency room of ILBS, New Delhi.
Structured Teaching Program - In this study, it refers to the structured teaching program
designed by the researcher for the management of upper GI bleeding among chronic liver
disease patients visiting Emergency Room and comprises of a checklist and guidelines.
Event - In this study, it refers to the visits made by a CLD patients with upper GI bleeding
to the Emergency department of ILBS from 8 AM to 8 PM Assumptions The study assumes that- The
nurses are practising as per their usual nursing practices while managing the patients with
upper GI bleeding.
Nursing Personnel have some knowledge in the practice related to management of upper GI
bleeding among CLD patients.
The nurses are documenting their nursing intervention correctly. The patient is managed by
the nurses through a nursing team approach. (Any nursing professional from the nursing team
can attend to the patient in the emergency room.) Structured teaching program will enhance
the patient care related to the management of upper GI bleeding among chronic liver disease
patients visiting Emergency Room.
Ethics Committee Clearance The Institutional Review Board clearance was obtained by two
processes, Scientific Review Committee and Ethics Committee Clearance was obtained from
Scientific Review Committee and Ethics Committee of College of Nursing, ILBS, and New Delhi.
Ethics approval to conduct the study was obtained from the college of nursing. All procedures
to be performed in this study involving human participants are in accordance with the ethical
standards of the Institutional Ethical Committee as laid down by WHO, ICMR and its later
amendments. Informed Consent will be taken from each participant after explanation and giving
Information Sheet Materials and Methods: - Quantitative research approach is used. Research
Design in the study One group Pre test - Post test design is used
The symbols used means:
O1: Assessment of nurses' practices related to management of upper GI bleeding among CLD
patients before intervention.
O2: Assessment of nurses' knowledge related to management of upper GI bleeding among CLD
patients before intervention.
O3: Assessment of nurses' practices related to management of upper GI bleeding among CLD
patients after intervention.
O4: Assessment of nurses' knowledge related to management of upper GI bleeding among CLD
patients after intervention.
X: Structured teaching program The present study will be conducted in Emergency Room at ILBS
hospital. In the present study, population comprises of Nurses working at ILBS. and the
target population comprises of Nurses working in Emergency Room, and accessible population
comprises of Nurses' providing care to upper GI bleeding among CLD patients visiting
Emergency Room at the time of data collection.
Sample Size:
Nurses: Total Enumeration. [ 20 nurses} Events: Total Enumeration (Total number of events in
the morning, evening and night shifts during data collection period will be observed i.e., 35
events).
Source of data Data will be collected from the study participants, nurses' record and
observation method The variables used in this study is Research variables i.e. Independent
Variable: Structured teaching program
Dependent Variable:
Knowledge of nurses regarding management of upper GI bleeding. Practices of nurses and their
response time regarding management of upper GI bleeding.
Factors affecting nurses' practices in the management of upper GI bleeding among chronic
liver disease patients.
Sociodemographic variables of nurses. Process of Data Collection For the final study, the
data was collected in the month of November, 2021 in the Emergency Room, ILBS, New Delhi.
Formal permission will be obtained from concerned authority to conduct the study. CLD
patients who are coming to emergency unit with upper GI bleeding. Observation of nurses'
practice were done by observation checklist from the time of receiving the patients from the
entrance of emergency unit till the referral to endoscopy or ward/ICU for further management.
Total enumeration sampling technique was used and those nursing personnel who will meet the
selection criteria will be recruited. Participant information sheet will be provided to each
participant to read followed by clear explanation of their rights and clarification of their
queries. Informed consent was signed and taken from every participant.
During data collection period, nursing personnel was asked to fill their demographic profile
data. Then principal investigator had assessed their practice using observation checklist
followed by assessment of knowledge using structured knowledge questionnaire. The structured
teaching programme was administered to nursing personnel in a group of 3 to 4 person. After
administration of teaching programme, principal investigator reassessed the practice and
knowledge of nursing personnel.
Tool for Data Collection:
These tools was selected after extensive review of literatures and expert's guidance.
Tool 1: Structured questionnaire to assess the Part-1: selected Socio-Demographic profile
Part-2: knowledge of Nurses' regarding management of upper GI bleeding Part-3: factors
affecting nurses' practices in the management of upper GI bleeding among chronic liver
disease patients visiting Emergency Room.
Tool 2: Observation checklist with response time to assess the nurses' practice while
managing patient with upper GI bleeding among chronic liver disease patients visiting
emergency room.
