| CTRI Number |
CTRI/2024/08/072402 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Video Assisted Teaching ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of video assisted teaching on anxiety and stress among patients undergoing PTCA |
|
Scientific Title of Study
|
An experimental study to assess effectiveness of video assisted teaching on anxiety and stress among patients undergoing PTCA at AIIMS Bhopal |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anurag Bhai Patidar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Cardiological/ Cardiothoracic Vascular Nursing,
Nursing College, All India Institute of Medical Sciences Bhopal,
Saket Nagar, Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
7898105551 |
| Fax |
|
| Email |
anurag.nursing@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyesh Vyas |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Cardiological/ Cardiothoracic Vascular Nursing,
Nursing College, All India Institute of Medical Sciences Bhopal,
Saket Nagar, Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9057826784 |
| Fax |
|
| Email |
priyeshv.mscnursing23@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Priyesh Vyas |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Cardiological/ Cardiothoracic Vascular Nursing,
Nursing College, All India Institute of Medical Sciences Bhopal,
Saket Nagar, Bhopal, Madhya Pradesh
MADHYA PRADESH
462020
India |
| Phone |
9057826784 |
| Fax |
|
| Email |
priyeshv.mscnursing23@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| Aiims Bhopal,Saket Nagar , Bhopal, Madhya Pradesh, India, pin code-462020 |
|
|
Primary Sponsor
|
| Name |
Dr.Anurag Bhai Patidar |
| Address |
Department of Cardiological/ Cardiothoracic Vascular Nursing,
Nursing College, All India Institute of Medical Sciences Bhopal,
Saket Nagar, Bhopal, Madhya Pradesh
462020 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Priyesh Vyas |
All India Institute of Medical Sciences Bhopal |
Cardiology Ward, Department of
Cardiology
Bhopal
Bhopal
MADHYA PRADESH |
9057826784
Priyeshv.mscnursing23@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, Bhopal Institutional Human Ethics Committee- Student Research (IHEC-SR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I249||Acute ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine Care |
This group will receive routine
care. No video assisted teaching will be conducted for
the control group. |
| Intervention |
Video Assisted Teaching |
Video assisted teaching is a method of teaching by which information on anatomy and physiology of heart, risk factors and symptoms of coronary artery disease, treatment modalities of CAD, PTCA procedure and lifestyle modifications following PTCA are provided to the patients subjected to PTCA with the help of 10-15 min. video.
The video assisted intervention of 15 minutes duration will be provided one time only before the day of procedure |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who has been planned for and admitted for elective PTCA.
2. Adult patients aged 20-60 years, both male & female patients undergoing for PTCA.
3. Patients who can read and write Hindi or English
|
|
| ExclusionCriteria |
| Details |
1. Patients who has undergone PTCA previously.
2. Patients who are critically ill.
3. Patients who are undergoing emergency PTCA
4. Patient who has vision and hearing impaired
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anxiety |
At Baseline, Post test on the day of PTCA before the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stress |
At Baseline, Post test on the day of PTCA before the procedure |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2024 |
| 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="0"
Months="4"
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
|
The focus of study is to check the preprocedural
anxiety and effectiveness of video assisted intervention to reduce anxiety
among patients undergoing PTCA In the daily routine, nurses find it difficult
to deal with patients’ and relatives’ anxiety in the pre-catheterization
period. so this intervention might play a effective role in increasing quality
of nursing and patient satisfaction. |