| CTRI Number |
CTRI/2025/03/082076 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Self-instructional module] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of self-learning guide in helping post-operative heart surgery patients understand how to prevent surgical wound infections. |
|
Scientific Title of Study
|
Effectiveness of the self-instructional module on knowledge regarding prevention of surgical site infection among post-operative cardiac patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Shiwani P Dandade |
| Designation |
Post-graduate Student |
| Affiliation |
Smt. Radhikabai Meghe Memorial College of Nursing, Sawangi Meghe, Wardha |
| Address |
Medical-Surgical Nursing Department, 2nd floor, SRMMCON, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8308597898 |
| Fax |
|
| Email |
shiwanidandade2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Arati Raut |
| Designation |
Assistant Professor |
| Affiliation |
Smt. Radhikabai Meghe Memorial College of Nursing, Sawangi Meghe, Wardha |
| Address |
Medical-Surgical Nursing Department, 2nd floor, SRMMCON, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9673771592 |
| Fax |
|
| Email |
aratiraut15714@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Arati Raut |
| Designation |
Assistant Professor |
| Affiliation |
Smt. Radhikabai Meghe Memorial College of Nursing, Sawangi Meghe, Wardha |
| Address |
Medical-Surgical Nursing Department, 2nd floor, SRMMCON, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9673771592 |
| Fax |
|
| Email |
aratiraut15714@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education & Research, Sawangi Meghe, Wardha, Maharashtra, 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education & Research, |
| Address |
Sawangi Meghe, Wardha, Maharashtra, 442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ms Shiwani P Dandade |
Smt. Radhikabai Meghe Memorial College of Nursing , Sawangi Meghe, Wardha. |
Medical-Surgical Nursing Department, 2nd floor, SRMMCON, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA |
08308597898
shiwanidandade2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education & Research, Sawangi Meghe, Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I469||Cardiac arrest, cause unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NILL |
NA |
| Intervention |
Self-instructional module |
A self-instructional module will be provided to post-operative cardiac patients.
first-day pre-test will be taken, then a self-instructional module will be provided, and after seven days, a post-test will be conducted. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1. Patients who are suffering from cardiac disease and have undergone surgery.
2. Post-operative cardiac patients who are willing to participate in this study.
3. Those patients who have developed post-operative surgical site infection.
4. Those patients who understand the Marathi and English language.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Post-operative cardiac patients who are critically ill and mentally ill.
2. Post-operative cardiac patients who are not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of the study will be that the self-instructional module is effective in post-operative cardiac. |
Assessment will be done at 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
NA |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction: Heart failure, often known as congestive heart failure
or congestive cardiac failure, is a common, expensive, debilitating, and
potentially fatal condition that arises when the heart is unable to produce
enough pump action to sustain blood flow to meet the body’s needs. An integral
part of managing cardiovascular risk is leading a healthy lifestyle.
Need of the
study: Surgical site infections in cardiac surgery remain a
significant medical problem due to the deteriorated postoperative quality of
life, increased mortality, more extended hospital stays, and increased
treatment costs.
Aim: The present study aims to evaluate the effectiveness of
self-instructional modules on knowledge regarding the prevention of surgical
site infection among post-operative cardiac patients.
Material and Methods: The study Design will be a
Quasi-Experimental Research Design (One Group Pre-Test, Post-Test Research
Design). 136 sample size will
be selected by using the purposive sampling technique, and non-probability will
be applied. The two years of the study were spent in the A.V.B.R.H. Sawangi
(Meghe), Wardha, Maharashtra, India. A structured questionnaire based on the
knowledge will be used to assess the effectiveness of the self-instructional
module on the prevention of surgical site infection. The tools will consist of - Section I: Demographical data like age,
gender, family income, occupation, education, stay in
the hospital after surgery, and
the type of cardiac
surgery. Section II: Structured knowledge questionnaire on the prevention of surgical site infection among post-operative
cardiac patients. Section III- It consists of self-instructional modules regarding the
prevention of surgical site infection among post-operative cardiac patients.
Section IV- Association of post-test
knowledge scores with their selected demographic variables.
To meet the study’s objectives,
the data gathered from the participants will be categorized and analysed using both descriptive and inferential statistics. One-way ANOVA will be applied to statistically evaluate the association of demographic
variables with the level of knowledge regarding the prevention of surgical site infection.
And for pre- and post-test evaluation of
the participants, a paired t-test will be used. |