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An Experimental Study of Psychological Effect of School Based-Yoga on Low-Income School Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03960944
Recruitment Status : Completed
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Collaborators:
Arsha Vidya Study Centre
United Research International
Information provided by (Responsible Party):
NMP Medical Research Institute

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.

Condition or disease Intervention/treatment Phase
Psychological Disturbance Anxiety Disorder of Childhood Other: Yoga Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Psychological Effect of School Based-Yoga on Low-Income School Children: Randomised Controlled Trial
Actual Study Start Date : May 21, 2018
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : March 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Yoga in School Group
30-mins yoga sessions were conducted in schools for 8-weeks
Other: Yoga
30 Min Yoga session included of Physical posture, Breathing exercise, Yoga games and Relaxation.

No Intervention: Control Group
Usual Activities in school



Primary Outcome Measures :
  1. Anxiety [ Time Frame: Change from baseline to 8 weeks ]
    Anxiety score was measured through State and Trait Anxiety Inventory


Secondary Outcome Measures :
  1. Depression [ Time Frame: Changes from baseline to 8 weeks ]
    Depression Score was measured through Beck Depression Inventory

  2. Self Esteem [ Time Frame: Changes from baseline to 8 weeks ]
    Self Esteem was measured through Rosenberg Self-esteem scale



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Low income Group
  • Parental consent to participate in study

Exclusion Criteria:

  • Disabilities
  • Substance abuse
  • Living outside the school areas

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960944


Locations
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India
NMP Medical Research Institute
Mumbai, Maharashtra, India
United Research International
Jaipur, Rajasthan, India
Arsha Vidya Study Centre
Chennai, Tamilnadu, India
Sponsors and Collaborators
NMP Medical Research Institute
Arsha Vidya Study Centre
United Research International
Investigators
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Study Chair: Buddhatmananda Saraswati Arsha Vidya Study Centre, India
Study Director: Divya Gaur United Research International, India
Principal Investigator: Rajubhai P Odedra NMP Medical Research Institute, India
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Responsible Party: NMP Medical Research Institute
ClinicalTrials.gov Identifier: NCT03960944    
Other Study ID Numbers: NMP/UNRI
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders