| CTRI Number |
CTRI/2024/07/070522 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to determine if screen time reduction and Surya Namaskars are useful in reducing back pain in school-going adolescents |
|
Scientific Title of Study
|
A before-and-after study to test a novel intervention (SanSKAR) in reducing the proportion of school-going adolescents reporting moderate-to-severe back pain |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gauri Oka |
| Designation |
Research Consultant |
| Affiliation |
Bharati Vidyapeeth Deemed to be Univerisity Medical College and Hositpal Pune |
| Address |
Room 933
9th floor,
Super specialty Building
Central Research and Publication Unit,
Bharati Vidyapeeth Deemed to be Univerisity Medical College and Hospital, Pune
Room 933
9th floor,
Super specialty Building
Central Research and Publication Unit,
Bharati Vidyapeeth Deemed to be Univerisity Medical College and Hospital, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9823828445 |
| Fax |
- |
| Email |
gauri.oka@bharatividyapeeth.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Prasad Pore |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be Univerisity Medical College and Hositpal Pune |
| Address |
Department of Community Medicine,
3rd floor,
Medical College Building,
Bharati Vidyapeeth Deemed to be Univerisity Medical College and Hospital, Pune
Department of Community Medicine,
3rd floor,
Medical College Building,
Bharati Vidyapeeth Deemed to be Univerisity Medical College and Hospital, Pune
MAHARASHTRA
411043
India |
| Phone |
9921073540 |
| Fax |
- |
| Email |
prasad.pore@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gauri Oka |
| Designation |
Research Consultant |
| Affiliation |
Bharati Vidyapeeth Deemed to be Univerisity Medical College and Hositpal Pune |
| Address |
Room 933
9th floor,
Super specialty Building
Central Research and Publication Unit,
Bharati Vidyapeeth Deemed to be Univerisity Medical College and Hospital, Pune
Room 933
9th floor,
Super specialty Building
Central Research and Publication Unit,
Bharati Vidyapeeth Deemed to be Univerisity Medical College and Hospital, Pune
MAHARASHTRA
411043
India |
| Phone |
9823828445 |
| Fax |
- |
| Email |
gauri.oka@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Central Research and Publication Unit
9th floor,
Super specialty Building
Bharati Hospital
Bharati Vidyapeeth Deemed to be University Medical College and Hospital, Pune
411043
|
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital, Pune |
| Address |
Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital, Pune 411043 |
| Type of Sponsor |
Private medical college |
|
|
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 Gauri Oka |
Bharati Hositpal |
Room 933
Central Research and Publication Unit
SuperSpecialty Building
Bharati Vidyapeeth Deemed to be University
Pune
Pune
MAHARASHTRA |
9823828445
gauri.oka@bharatividyapeeth.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University) Medical College Insitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Screen time reduction and Surya Namaskars |
Restriction of total screen time to not more than 60 minutes per day
AND
Performance of 12 Surya Namaskars, each taking not more than 1.5 minutes, performed continuously after 5 minutes of warm-up exercise and followed by 5 minutes of Shavasana at least 5 days a week for 16 weeks |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Boys and girls from English and Marathi medium schools in Pune Division |
|
| ExclusionCriteria |
| Details |
No consent from parents.
No assent from children. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the proportion of adolescents reporting moderate to severe back pain |
8 and 16 weeks after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the overall proportion of school-going adolescents reporting back pain |
8 and 16 weeks after intervention |
|
|
Target Sample Size
|
Total Sample Size="540"
Sample Size from India="540"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="637" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/07/2024 |
| Date of Study Completion (India) |
31/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
There is sufficient evidence in the currently
available scientific literature to hypothesize that a structured intervention
tailor-made for implementation in the school environment that includes Surya Namaskars
and limitation of screen time exposure with parent and teacher engagement could
be beneficial in reducing the prevalence and/or intensity of non-specific back
pain in school-going children and adolescents.
This intervention needs to be feasible for
execution in the school environment, requiring minimal resources, and with student,
teacher, and parent engagement so that the shared responsibility makes it more
acceptable and workable.
The objective of this research is to test a
novel comprehensive interventional module incorporating screen time
reduction and Surya Namaskars (SanSKAR) so as to
maximize its feasibility and acceptability. The results of the project could help
in making recommendations for stakeholders. |