| CTRI Number |
CTRI/2020/11/028891 [Registered on: 04/11/2020] Trial Registered Prospectively |
| Last Modified On: |
27/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Video on Stress Management among adolescents in Uttarakhand. |
|
Scientific Title of Study
|
An experimental study to evaluate the effectiveness of Stress Management Strategies (Video Instruction) on the knowledge, attitude and practices among adolescents studying in senior secondary schools of state Uttarakhand. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rupinder Deol |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
College of Nursing,Veerbhadra Road
AIIMS Rishikesh
Flat No.62402, Building No.62, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7055074477 |
| Fax |
|
| Email |
deolrains@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RUPINDER DEOL |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
College of Nursing,Veerbhadra Road
AIIMS Rishikesh
Flat No.62402, Building No.62, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7055074477 |
| Fax |
|
| Email |
deolrains@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RUPINDER DEOL |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
College of Nursing,Veerbhadra Road,
AIIMS Rishikesh
Flat No. 62402, Building No.62, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7055074477 |
| Fax |
|
| Email |
deolrains@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rupinder Deol (Self Funded)
AIIMS Rishikesh |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [None] |
|
|
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 |
| Rupinder Deol |
Study will be done at selected schools of state Uttarakhand. Researcher is from AIIMS Rishikesh |
Assistant Professor, College of Nursing, Veerbhadra Road, AIIMS Rishikesh
Dehradun
UTTARANCHAL |
7055074477
deolrains@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adolescents |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention |
No intervention |
| Intervention |
Video instruction on stress management strategies |
Video will be shown on various stress management strategies to intervention group. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Who give assent to participate in study.
Whose parents give consent to participate in study.
Who can read and understand Hindi or English.
|
|
| ExclusionCriteria |
| Details |
Who are not studying in 10+1 or 10+2 |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of stress management strategies in terms of level of perceived stress, knowledge, attitude and practices of stress management among adolescents |
Baseline,after 1 week, 4 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
none |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
15/12/2020 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim: To evaluate the effectiveness of stress management strategies (Video Instruction) on the knowledge, attitude and practices among adolescents studying in senior secondary schools of state Uttarakhand.
Objectives: 1. To assess pre and post test level of perceived stress among adolescents studying in senior secondary schools of Uttarakhand. 2. To develop a video instruction on various stress management strategies for adolescents. 3. To assess the knowledge, attitude and practice of adolescents regarding various stress management strategies before and after the administration of video instruction. 4. To compare the differences in the knowledge, attitude and practice of adolescents regarding various stress management strategies before and after the administration of video instruction. Research design: experimental pre-test post test control group. Setting: senior secondary schools of state Uttarakhand. Sample: Adoelscents between 16 to 19 years of age. Tools for data collection: social demographic profile, perceived stress scale, structured knowledge questionnaire, attitude skill, practice checklist.
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