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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
 
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 
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.

 
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