| CTRI Number |
CTRI/2025/01/079125 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nurse-Led-Interventions(Resilience Interventions)] |
| Study Design |
Other |
|
Public Title of Study
|
Resilience Interventions on Estimation of Saliva cortisol,
Perceived stress, Emotional regulation and Psychological resilience among students studying in selected schools at coimbatore, Tamilnadu |
|
Scientific Title of Study
|
Effectiveness of Nurse-Led-Interventions on Bio-Psycho-Social aspects among students studying in selected schools at coimbatore, Tamilnadu |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P Jamunarani |
| Designation |
Professor |
| Affiliation |
KMCH College of Nursing, Coimbatore |
| Address |
Prof.Jamunarani P, KMCH College of Nursing, Kalapatti Post, Coimbatore-48
Coimbatore TAMIL NADU 641048 India |
| Phone |
7358914824 |
| Fax |
|
| Email |
jamunarani@kmchcon.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Jamunarani P |
| Designation |
Professor |
| Affiliation |
KMCH College of Nursing Coimbatore |
| Address |
KMCH College of Nursing
259 267 kalapatti Post
Coimbatore-641048 KMCH College of Nursing
259 267 kalapatti Post
Coimbatore-641048 Coimbatore TAMIL NADU 641048 India |
| Phone |
7358914824 |
| Fax |
- |
| Email |
jamunarani@kmchcon.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Jamunarani P |
| Designation |
Professor |
| Affiliation |
KMCH College of Nursing |
| Address |
KMCH College of Nursing
259& 267 , Kalapatti Post
Coimbatore-641048
Coimbatore TAMIL NADU 641048 India |
| Phone |
7358914824 |
| Fax |
|
| Email |
jamunarani@kmchcon.ac.in |
|
|
Source of Monetary or Material Support
|
| 1. Sri. Vivekananda Matric Higher secondary school,
R.G. PUDUR, COIMBATORE-641062
2. R.J Matric Higher secondary school
no: 15, Gandhi street, Vilankurinchi, Coimbatore- 641035
3. Kadri Mills HIGHER SECONDARY SCHOOL,Ordarpalayam, Ondipudur(PO), Coimbatore- 641016
4. Thiyagi N.G. Ramaswamy Memorial Higher secondary school, Kamarajar road, Varadharajapuram, Coimbatore- 641015 |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
KMCH College of Nursing
259 267 Kalapatti Post
coimbatore-641048 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jamunarani P |
Vivekananda Matric Higher secondary school |
Sri. Vivekananda Matric Higher secondary school, R.G. PUDUR, COIMBATORE-641062 Coimbatore TAMIL NADU |
7358914824
jamunarani@kmchcon.ac.in |
| Jamunarani P |
Kadri Mills Higher Secondary School |
Kadri Mills Higher Secondary School, Ordarpalayam, Ondipudur(PO), Coimbatore- 641064 Coimbatore TAMIL NADU |
7358914824
jamunarani@kmchcon.ac.in |
| Jamunarani P |
R.J Matric Higher secondary school |
R.J Matric Higher secondary school No:15,Gandhi street, Vilankurinchi,Coimbatore- 641035
Coimbatore TAMIL NADU |
7358914824
jamunarani@kmchcon.ac.in |
| Jamunarani P |
Thiyagi N.G Ramaswamy Memorial Higher Secondary School |
Thiyagi N.G Ramaswamy Memorial Higher Secondary School, Kamarajar Road, Varadharajapuram, Coimbatore-641015 Coimbatore TAMIL NADU |
7358914824
jamunarani@kmchcon.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Kadri Mills Higher Secondary School |
No Objection Certificate |
| KMCH ETHICS COMMITTEE |
No Objection Certificate |
| R.J Matriculation Higher Secondary School |
No Objection Certificate |
| Sri Vivekananda Matric Higher secondary School |
No Objection Certificate |
| SriRamachandra Institute of Higher Education and Research |
Approved |
| Thiyagi N.G. Ramaswamy Memorial Higher secondary School |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal School Children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NO Interventions till Post test for control group |
After Post test II control group will be receiving same Nurse-Led-Interventions(Resilience Interventions).
The programme will be delivered once in a week for 8weeks with the duration of 40 minutes that is 1 period (20 mts for teaching and it will be enacted by the study subjects for 20 mts) and 8 sessions by using different teaching strategies |
| Intervention |
Nurse-Led-Interventions (Resilience Interventions) |
The Interventions will be planned at various sessions include Emotional Regulation & Emotional Self-awareness, Assertiveness, Anger Management, Coping with Stress & Coping with emotions, Self care, Building Resilience and Mindfulness. The programme will be delivered once in a week for 8weeks with the duration of 40 minutes that is 1 period (20 mts for teaching and it will be enacted by the study subjects for 20 mts) and 8 sessions by using different teaching strategies
Frequency ( Post Test I & II -2 times)
Duration of The programme will be delivered once in a week for 8 weeks with the duration of 1 period (20 mts period for teaching and it will be enacted by the study subjects for 20 mts, totally 40 minutes) in 8 sessions. After the intervention post test– I & II will be conducted at 20th week and 36th week respectively. Follow up care will be undertaken by the researcher after completion of the Interventions for every 2 weeks. Then Post test –I will be assessed at 20th week. After that Reinforcement will be given by the researcher in every month for next 3 consecutive months. Then Post test 2 will be conducted at 36th month. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Students of both gender will be included
2. Students those who are studying in 9th standard
3. Students those who are willing to participate
4. Students who are available during the time of data collection
5. Students those who are having moderate and high perceived stress, Low resilience, low emotional regulation score will be included.
|
|
| ExclusionCriteria |
| Details |
1. Students who have already attended any Resilience Emotional Skill Training, Personality development programme & Life skill training programme in their previous years as well as in on-going |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Reduction in stress, Increase Emotional Regulation and enhance Psychological Resilience among school students as it will be measured by Salivary Cortisol, Perceived stress scale,Emotion Regulation questionnaire and Bharathiyar University Resilience Scale
|
Pre test (Base line) will be assessed for-4 weeks
Nurse-Led Interventions(8 weeks)
Follow up -I & II WILL BE DONE(AFTER THE INTERVENTION EVERY 2 WEEKS ONCE)
POST TEST-I WILL BE CONDUCTED (20th week)
Reinforcement -I, II & III WILL BE CONDUCTED FOR EVERY MONTH ONCE FOR NEXT 3 CONSECUTIVE MONTHS(36 TH WEEK) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To maintain a well balanced Mentally Healthy Life |
Pre test (Base line) will be assessed for-4 weeks
Nurse-Led Interventions(8 weeks)
Follow up -I & II WILL BE DONE(AFTER THE INTERVENTION EVERY 2 WEEKS ONCE)
POST TEST-I WILL BE CONDUCTED (20th week)
Reinforcement -I, II & III WILL BE CONDUCTED FOR EVERY MONTH ONCE FOR NEXT 3 CONSECUTIVE MONTHS
POST TEST -II will be conducted at 36 TH WEEK. |
|
|
Target Sample Size
|
Total Sample Size="600" Sample Size from India="600"
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)
|
04/02/2025 |
| 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 Applicable |
| 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
|
Nurse-Led-Interventions ( Resilience Interventions): It refers to systematically planned Nurse-Led- Interventions for school students to improve Bio- Psychological and Sociological adaptation that enable them to deal effectively with the demands and challenges of everyday life. The Interventions will be planned at various sessions include Emotional Regulation & Emotional Self-awareness, Assertiveness, Anger Management, Coping with Stress & Coping with emotions, Self care, Building Resilience and Mindfulness. The programme will be delivered once in a week for 8weeks with the duration of 40 minutes that is 1 period (20 mts for teaching and it will be enacted by the study subjects for 20 mts) and 8 sessions by using different teaching strategies viz Role play, Demonstration, Video presentation, lecture interweaved with group discussion, Brain Storming, Situation analysis, followed by activity session viz conducting games, Case vignette discussion and worksheet. The data collection will be done for one academic duration among School children in private Matriculation Govt aided High & Higher secondary school, Coimbatore. Before conducting the study, the researcher will get permission from Principal/School Head Master/ Head mistress, followed by getting approval from Nursing Research Monitoring Committee and Institute Ethics committee. The written consent will be obtained from parents and assent form from the eligible and willing participants after explaining the purpose of the study. The investigator and Research trainer will introduce herself and make good rapport with the participants by an informal talk to ensure their cooperation. The school children will be assessed according to their inclusion criteria. Pretest will be assessed for 4 weeks for both Study and Control groups. The instruments will be used in this study are Background Variables, Perceived stress scale & Emotional Regulation Questionnaire- children and Adolescence (ERQ-CA) and Bharathiar University Resilience Scale. Students those who got Moderate and high perceived stress score, Low resilience score and low emotional regulation score will be taken as objective measurement of salivary cortisol level as Well as will be taught Nurse-Led-Interventions. Each student will be taken 30 to 45 min to complete all questionnaires. The researcher will teach about Nurse-Led- Interventions to the school students who will be in study group as per specific objectives. Based on sample size calculation each school 50 students will be taken. Rest of the students in the class also will be receiving same Nurse-Led-Interventions simultaneously. Each session will be conducted for 1 period (20 minutes period for teaching and it will be enacted by the study subjects for 20 mts, totally 40 minutes) for 8 week duration with 8 sessions. The investigator will be giving training to 4 research trainer at the same time. This intervention will be given by research trainer. pre test assessment will be given for1 month duration. Samples will be recruited after screening. Rapport will be established. Orientation, introduction & detailed about the modules on Nurse-Led-Interventions (Resilience Training) will be explained to the selected samples. V week by using lecture cum discussion, Brain storm technique, storytelling& discussion methods emotional self awareness& skill will be taught. In this session identification & assessment of feelings & thoughts, actions of their own will be done. In VI week through role playing, real life situations will be explained for anger management. In this session analysis of perception of self & factors that contribute to anger will be assessed. VII, VIII week, the participants will be taught situation analysis, games & home work to cope with emotions & stress. In this session, samples will be taught to recognize the effects of emotions on others and themselves & identify the source of stress in their life & how these affect them. In IX week situation analysis & role playing with real life will be done for assertiveness skill training. In this session discussion about types of behavior pattern in assertiveness skill training. X week debates, brain storming activity, gratitude jar activity will be done to build resilience. In this session importance of resilience will be discussed. XI week situation analysis & case studies will be discussed to teach psychological self care. In this session problems will be identified & solution will be discovered for managing self care. XII week session will be taught about Mindfulness breathing and eating. The intervention package includes emotional self awareness, Coping with emotions & stress, self awareness, Self–esteem, Assertiveness, Resilience, anger management, Psychological Self care& Mindful breathing and eating. Hands on skill training intervention will be executed by Power point presentation, case vignette, giving examples with real life situation, group discussion, brain storming, worksheet activity, video clips and role play. Students who will be in control group will not receive this intervention. After giving intervention, Diary will be maintained immediately after each session regarding this activity. Return demonstration also will be done by the students with the help of Research trainer. The researcher will be conducting post test 1 and 2 among students in study and control group on 20th and 36th week. Follow up care will be undertaken by the researcher after completion of the Intervention for every 2 weeks. Then Post test –I will be assessed at 20th week. After that Reinforcement will be given by the researcher and Research trainer in every month for next 3 consecutive months. Then Post test 2 will be conducted at 36th month. After post test 2 researchers will teach about Nurse-Led- Interventions to control group. After Post test-II Control group will receive same interventions. |