| CTRI Number |
CTRI/2022/12/048546 [Registered on: 27/12/2022] Trial Registered Prospectively |
| Last Modified On: |
26/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFfect Of MASTERING THE EMOTION TECHNIQUE On The Emotion Regulation And Cognitive Well Being Of Adolescents |
|
Scientific Title of Study
|
EFFECT OF MASTERING THE EMOTION TECHNIQUES ON THE EMOTION REGULATION AND COGNITIVE WELL BEING OF ADOLESCENTS |
| Trial Acronym |
MEMT ( Mastering the emotion technique) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manjula K R |
| Designation |
PhD scholar |
| Affiliation |
Swami Vivekananda yoga anusandhana samsthanam |
| Address |
33 7th main pramoda layout panthara palya
nayandahalli post Bangalore
Yoga and humanities division, Eknath Bhavan gavipuram circle
Bangalore
KARNATAKA
560039
India |
| Phone |
09972655996 |
| Fax |
|
| Email |
manjula.sridhar33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyaprakash Purohit |
| Designation |
Assistant Professor and guide |
| Affiliation |
Swami Vivekananda Yoga Anusandana Samsthana SVYASA |
| Address |
Yoga and humanities division Eknath Bhavan Gavipuram Circle Kempegowda Nagar
Bangalore
KARNATAKA
560019
India |
| Phone |
7676745174 |
| Fax |
|
| Email |
satyaprakash.purohit@svyasa.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Manjula K R |
| Designation |
PhD scholar |
| Affiliation |
Swami Vivekananda yoga anusandhana samsthanam |
| Address |
33 7th main pramoda layout panthara palya
nayandahalli post Bangalore
Yoga and humanities division Eknath Bhavan gavipuram circle
Bangalore
KARNATAKA
560039
India |
| Phone |
09972655996 |
| Fax |
|
| Email |
manjula.sridhar33@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swami Vivekananda Yoga Anusandhana Samsthana gavipuram circle bangalore 560019 |
|
|
Primary Sponsor
|
| Name |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
19 Eknath Bhavan Gavipuram circle Kempegowda nagar bengaluru 560019 |
| 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 |
| manjula |
Sri sai vidyalaya |
1st d main road mariappanapalya rajajinagar
Bangalore
KARNATAKA |
09972655996
manjula.sridhar33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee S-VYASA |
Approved |
| sri sai vidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy human |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group counselling and meditation technique |
30 minutes of group counselling and meditation ( Mastering the Emotion technique by SVYASA) intervention for 12 weeks will be given to adolescents between the age 14 - 18 years for both boys and girls. A follow up of 12 weeks will be done after intervention. emotion regulation will be the screening variable. |
| Comparator Agent |
recreation session |
The control group will be involved in activities such as drawing craft and story telling |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
read and write English attending school regularly both boys and girls from schools and colleges from urban bangalore students will be screened |
|
| ExclusionCriteria |
| Details |
major psychological issues/problems suffering from any chronic illness as indicated in the demographic self-disclosure form or personally informed to the researcher |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart Rate Variability
emotion regulation
self esteem
mindfulness
self compassion
cognitive(attention and psychomotor ) |
outcomes will be measured 1st week, 12th week and 24th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
behavior
anxiety |
outcomes will be measured 1st week and 24th week. |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
12/01/2023 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, pre-post study with control group intervention establishing effet of counseling and meditation technique, 12 weeks group sessions followed by 12 weeks follow up for the adolescents in the age group of 14 - 18 years. The study will be conducted in a school and pre-university college in India. The primary outcome is better heart rate variability, emotional regulation, mindfulness,self-compassion, and self-esteem. The secondary outcome will be better in behavior and lower anxiety issues. |