Back to resultsAn Experimental Study of Psychological Effect of School Based-Yoga on Low-Income School Children
Primary Purpose
Psychological Disturbance, Anxiety Disorder of Childhood
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Yoga
Sponsored by
About this trial
This is an interventional supportive care trial for Psychological Disturbance
Eligibility Criteria
Inclusion Criteria:
- Low income Group
- Parental consent to participate in study
Exclusion Criteria:
- Disabilities
- Substance abuse
- Living outside the school areas
Sites / Locations
- NMP Medical Research Institute
- United Research International
- Arsha Vidya Study Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Yoga in School Group
Control Group
Arm Description
30-mins yoga sessions were conducted in schools for 8-weeks
Usual Activities in school
Outcomes
Primary Outcome Measures
Anxiety
Anxiety score was measured through State and Trait Anxiety Inventory
Secondary Outcome Measures
Depression
Depression Score was measured through Beck Depression Inventory
Self Esteem
Self Esteem was measured through Rosenberg Self-esteem scale
Full Information
NCT ID
NCT03960944
First Posted
May 21, 2019
Last Updated
May 21, 2019
Sponsor
NMP Medical Research Institute
Collaborators
Arsha Vidya Study Centre, United Research International
1. Study Identification
Unique Protocol Identification Number
NCT03960944
Brief Title
An Experimental Study of Psychological Effect of School Based-Yoga on Low-Income School Children
Official Title
Psychological Effect of School Based-Yoga on Low-Income School Children: Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
March 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NMP Medical Research Institute
Collaborators
Arsha Vidya Study Centre, United Research International
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Poverty is a common experience for many children and families in developing countries. Living in a poor or low-income household has been linked to poor health and increased risk for mental health problems than the general population. Previous studies link psychological well-being with yoga in adolescents and children. This study investigated the effects of a structured yoga program on psychological well-being in low-income school children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Disturbance, Anxiety Disorder of Childhood
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga in School Group
Arm Type
Experimental
Arm Description
30-mins yoga sessions were conducted in schools for 8-weeks
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Usual Activities in school
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
30 Min Yoga session included of Physical posture, Breathing exercise, Yoga games and Relaxation.
Primary Outcome Measure Information:
Title
Anxiety
Description
Anxiety score was measured through State and Trait Anxiety Inventory
Time Frame
Change from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Depression
Description
Depression Score was measured through Beck Depression Inventory
Time Frame
Changes from baseline to 8 weeks
Title
Self Esteem
Description
Self Esteem was measured through Rosenberg Self-esteem scale
Time Frame
Changes from baseline to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Low income Group
Parental consent to participate in study
Exclusion Criteria:
Disabilities
Substance abuse
Living outside the school areas
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Buddhatmananda Saraswati
Organizational Affiliation
Arsha Vidya Study Centre, India
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Divya Gaur
Organizational Affiliation
United Research International, India
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rajubhai P Odedra
Organizational Affiliation
NMP Medical Research Institute, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
NMP Medical Research Institute
City
Mumbai
State/Province
Maharashtra
Country
India
Facility Name
United Research International
City
Jaipur
State/Province
Rajasthan
Country
India
Facility Name
Arsha Vidya Study Centre
City
Chennai
State/Province
Tamilnadu
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
An Experimental Study of Psychological Effect of School Based-Yoga on Low-Income School Children
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