| CTRI Number |
CTRI/2024/12/078516 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Planned Teaching on knowledge regarding stress reduction ] |
| Study Design |
Other |
|
Public Title of Study
|
Use of teaching program for heart patients to manage tension and improve health. |
|
Scientific Title of Study
|
Effectiveness of planned teaching program on knowledge regarding stress reduction strategies among coronary heart disease 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 |
Vaishnavi Telrandhe |
| Designation |
Post graduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of medical surgical nursing 1st floor Smt.Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
09146587792 |
| Fax |
|
| Email |
vaishnavitelrande169@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MrsArati Raut |
| Designation |
Assitant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of medical surgical nursing 1st floor Smt.Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9673771592 |
| Fax |
|
| Email |
aratiraut15714@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MrsArati Raut |
| Designation |
Assitant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of medical surgical nursing 1st floor Smt.Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha
MAHARASHTRA
442001
India |
| Phone |
9673771592 |
| Fax |
|
| Email |
aratiraut15714@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha 442001 India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha Maharashtra 442001 India |
| 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 |
| DrVaishnavi Telrandhe |
Acharya Vinoba Bhave Rural Hospital |
Department of Cardiology 2nd Floor, SMSC Building Sawangi Meghe
Wardha
MAHARASHTRA |
9146587792
vaishnavitelrande169@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Planned Teaching Program |
The planned teaching program will be conducted on knowledge regarding stress reduction strategies among coronary artery disease patients at Acharya Vinoba Bhave Hospital after taking pretest.The study will be conducted in 2 year time period
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are suffering from coronary artery disease.
2.Patients who are having fear and anxiety related to heart surgery and its prognosis.
3.Those patients who understand Marathi and the English language.
|
|
| ExclusionCriteria |
| Details |
1.Patients who are suffering from psychiatric conditions
2.Patient who are suffering chronic illness like cancer AIDS etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stress reduction through planned teaching sessions |
Assessment will be done after 7 days after providing planned teaching session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/01/2025 |
| 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="2"
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
|
Stress, according to the WHO, is a condition of anxiety or mental strain brought on by a difficult circumstance. Humans naturally react to stress by addressing obstacles and threats. Everyone goes through periods of stress. Patients also have fear, anxiety, and stress related to their health status, disease condition recovery, and complications of the disease. Current estimates from epidemiologic studies from various parts of the country indicate a prevalence of Coronary heart disease to be between 7% and 13% in urban and 2% and 7% in rural populations. Epidemiologic studies have shown that there are, at present, over 30 million cases of Coronary heart disease in this country. One-sixth of patients with newly diagnosed CAD meet the criteria for significant stress and depression; at the one-year followup, only one-sixth of those who were depressed had received treatment. Cardiovascular diseases account for approximately one-third of all adult deaths over the age of 35. Stress and specific behaviours such as aggressiveness, hostility, an overly competitive sense of time urgency, and competitive striving for achievement are thought to play a role in the pathogenesis of Coronary heart disease. Stress was associated with worsening quality of life, physical and social functioning, and heart failure symptoms. Method and materials:-The study followed an experimental research design, specifically a one-group pretest-post-test design, to evaluate the effectiveness of a teaching program on stress reduction strategies among coronary heart disease (CHD) patients. The research was conducted at A.V.B.R.H. Sawangi Meghe, where the study population consisted of patients diagnosed with coronary heart disease. The study was carried out over a period of two years, allowing sufficient time to assess the impact of the teaching program. The setting of the study was focused on the CHD patients at A.V.B.R.H. Sawangi Meghe, ensuring that the findings were relevant to this specific group. Aim:- The study aimed to evaluate the impact of stress-reduction techniques on patients with coronary heart disease patients.
|