| CTRI Number |
CTRI/2018/07/014945 [Registered on: 18/07/2018] Trial Registered Prospectively |
| Last Modified On: |
28/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Health program on educational stress among adolescent girls |
|
Scientific Title of Study
|
: Efficacy of holistic group health promotion program on wellbeing, academic stress, anxiety, depression and academic performance among adolescent girls |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sreevani Rentala |
| Designation |
Nursing Professor and Head |
| Affiliation |
DIMHANS, Dharwad |
| Address |
Nursing Department,Academic Block, Dharwad Institute of Mental Health Health and Neurosciences,
Belgaum road,
Dharwad - 580008
Dharwad
KARNATAKA
580008
India |
| Phone |
9880778933 |
| Fax |
|
| Email |
sreevani.phd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sreevani Rentala |
| Designation |
Nursing Professor and Head |
| Affiliation |
DIMHANS, Dharwad |
| Address |
Nursing Department, Academic Block, Dharwad Institute of Mental Health Health and Neurosciences, Belgaum road, Dharwad - 580008
Dharwad
KARNATAKA
580008
India |
| Phone |
9880778933 |
| Fax |
|
| Email |
sreevani.phd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sreevani Rentala |
| Designation |
Nursing Professor and Head |
| Affiliation |
DIMHANS, Dharwad |
| Address |
Nursing Department, Academic Block, Dharwad Institute of Mental Health Health and Neurosciences, Belgaum road, Dharwad - 580008
Dharwad
KARNATAKA
580008
India |
| Phone |
9880778933 |
| Fax |
|
| Email |
sreevani.phd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dharwad Institute of Mental Health and Neurosciences, Belgaum road, Dharwad - 580 008
Karnataka |
|
|
Primary Sponsor
|
| Name |
Indian Council of Social Science Research |
| Address |
Indian Council of Social Science Research, Ministry of Human Resource Development,
JNU Institutional area, Aruna Asaf Ali Marg
New Delhi 110067 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Sreevani Rentala |
Dharwad |
Dharwad Institute of mental health and neurosciences, dharwad, karnataka 580008
Dharwad
KARNATAKA |
9880778933
sreevani.phd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethic review board, Dharwad Institute of mental Health and Neurosciences, Dharwad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
who are having stress will be screened by using stress scale |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Holistic Group Health Promotion Program |
200 subjects will be selected based on their stress levels, subjects are randomly assigned to experimental and control group. experimental group subjects will participate in 4 weekly session of holistic program. control group subjects will not receive any intervention |
| Intervention |
Holistic Group Health Promotion Program |
200 subjects will be selected based on their stress levels, subjects are randomly assigned to experimental and control group. experimental group subjects will participate in 4 weekly session of holistic program. control group subjects will not receive any intervention. Both groups will be assessed on outcome variables every month for 6 months.
experimental subjects receive following interventions
mini lectures on holistic health concept, acupressure exercises, breathing exrcises, mindful meditation, group sharing exercises, self love techniques, mirror exercises, therapeutic writing, drawing, home work activities, focusing on personal strengths.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
1. Aged between 16 to 19 years
2. Who are willing to participate
|
|
| ExclusionCriteria |
| Details |
1. Subjects who are undergoing other form of counselling or relaxation therapies(psychological counselling, yoga program, or any other stress reduction programs )
2. A significant medical or Psychiatric condition that could interfere with participation in therapy.
3. Adolescents who are suffering with Specific learning disorder
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of academic stress, anxiety and depression, improving wellbeing and academic performance among adolescent girls
|
Both the group subjects are assessed at monthly intervals for 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| participation in holistic group health promotion enhance the wellbeing and academic performance among adolescent girls and helps in overall personality development and balanced life style. |
Both the group subjects are assessed at monthly intervals for 6 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
23/07/2018 |
| 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="6"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
3. Rentala S, Lau BH, Aladakatti R, Thimmajja SG. Effectiveness of holistic group health promotion program on educational stress, anxiety, and depression among adolescent girls – A pilot study. J Family Med Prim Care. 2019;8:1082-9, PMID: 31041255 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The main aim of the study is to assess the efficacy of holistic group health promotion program in reducing academic stress, anxiety and depression, improving wellbeing and academic performance among adolescent girls.this study will utilize IQ assessment scale, Eysenk’s personality Inventory, Body Mind Spirit wellbeing inventory, Educational Stress Scale for Adolescents, Depression, Anxiety and Stress Scale and Structured questionnaire to assess academic performance. sample consists of 200 adolescent girls (100 experimental and 100 control group) who are studying in selected Pre and degree colleges. Data collection includes pre assessment of subjects on outcome variables, implementation of intervention to experimental subjects for 4 weeks, control group subjects will not receive any intervention. Both groups will be assessed every month on outcome variables for 6 months. Activities of Holistic Group Health promotion includes mini lectures on holistic health concept, relationship between body-mind-spirit, general instructions to health and sleep hygiene techniques, acupressure exercises, breathing exercises, back massage exercises, mindful meditation and guided imagery meditation, group sharing activities, self love techniques and mirror exercises, therapeutic writing, drawing and home work activities and focusing on personal strengths. |