| CTRI Number |
CTRI/2025/08/093779 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
assess the impact of a teaching program on mental health awareness among eligible couples.
|
|
Scientific Title of Study
|
Effectiveness of planned teaching programme on knowledge regarding promotion of mental health among eligible couples |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
saloni Moon |
| Designation |
Post graduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Mental Health Nursing Shrimat Radhikabai Meghe Memorial college of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9823218819 |
| Fax |
|
| Email |
salonimoon1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pooja Kasturkar |
| Designation |
Assistant Professor of Mental Health Nursing |
| Affiliation |
Datta Meghe Institue of Higher Education and Research |
| Address |
Smt Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha Datta Meghe Institue of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
09673886027 |
| Fax |
|
| Email |
poojakasturkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja kasturkar |
| Designation |
Dean Cum HOD of Mental Health Nursing |
| Affiliation |
Datta Meghe Institue of Higher Education and Research |
| Address |
Smt Radhikabai Meghe Memorial College Of Nursing Sawangi Meghe Wardha Datta Meghe Institue of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
09673886027 |
| Fax |
|
| Email |
poojakasturkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education and Research Sawangi Meghe Wardha India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Sawangi Meghe Wardha India 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 |
| Saloni Moon |
Community area |
Rural Area Sawangi Meghe Wardha
Wardha
MAHARASHTRA |
09823218819
salonimoon1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Datta Meghe Institue of Higher Education and Research |
Approved |
| Grampanchayat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F69||Unspecified disorder of adult personality and behavior, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Planned teaching program on promotion of mental health among eligible couples. |
The programme covers key topics such as the definition, prevalence, causes, signs, and strategies for promoting mental health. It includes interactive lectures, discussions, case scenarios, and visual aids. Pre-test and post-test questionnaires are used to assess knowledge before and after the session. The expected outcome is improved awareness, better communication, and adoption of positive mental health practices among couples.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Eligible couples who are married
2, Eligible couples who are age group between 18- 45 years
3. Eligible couples who are not used any permanent method of family planning
|
|
| ExclusionCriteria |
| Details |
1. Eligible couples who are currently undergoing treatment for mental health issues.
2. Eligible couples who are participate similar study in last for 6 months.
3. Eligible couples who are unable to understand the language of the program
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome of the study was the improvement in knowledge related to the promotion of mental health among eligible couples. The effectiveness of the planned teaching programme was measured by comparing knowledge levels before and after the intervention using structured tools.
|
The study assessed effectiveness at multiple time points: a pre-test was done before the intervention, followed by a post-test immediately after. A second post-test was conducted two weeks later, and a follow-up was done after one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes of the study included improved knowledge toward mental health, better mental health–promoting behaviors, and enhanced spousal communication. Participants showed increased willingness to seek professional help and greater awareness of available mental health services. The programme also led to reduced stress levels, improved self-confidence, and stronger perceived social support. Additionally, participants expressed satisfaction with the teaching programme and retained the gained knowledge over time. |
The effectiveness of the planned teaching programme was assessed at multiple time points. A pre-test was conducted before the intervention to measure baseline knowledge. A post-test was administered immediately after the session to assess immediate impact. Further assessments were done two weeks and one month after the intervention to evaluate knowledge retention and lasting changes. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/09/2025 |
| 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
|
AbstractBackground: Mental health is a crucial aspect of overall well-being, especially within families. Eligible couples often lack sufficient knowledge regarding mental health promotion, which may affect their emotional, social, and relational stability. Educational interventions like planned teaching programmes can play a key role in enhancing awareness and encouraging healthy mental health practice. Aim: To evaluate the effectiveness of a planned teaching programme on improving knowledge regarding the promotion of mental health among eligible couples. Methods: A pre experimental pre-test and post-test design was adopted for the study. Eligible couples were selected through purposive sampling. A structured knowledge questionnaire was used to assess participants’ knowledge levels before the intervention (pre-test), immediately after (post-test 1), two weeks later (post-test 2), and one month later (follow-up). The planned teaching programme included interactive sessions focused on mental health concepts, stress management, emotional well-being, and communication skills. Results: The study findings revealed a significant increase in knowledge scores after the intervention. Improvement was observed immediately after the session and was sustained over two-week and one-month follow-up periods. Participants also demonstrated improved awareness and a more positive attitude towards mental health. Conclusion: The planned teaching programme was effective in improving knowledge and promoting mental health awareness among eligible couples Such programmes can be beneficial in strengthening mental health at the family and community levelsKeywords: Mental health, Eligible couples, Knowledge, Planned teaching programme, Awareness |