Psychological DisturbanceNCT03960944
An Experimental Study of Psychological Effect of School Based-Yoga on Low-Income School Children
A study testing Yoga in people with Psychological Disturbance and Anxiety Disorder of Childhood, run by NMP Medical Research Institute at 3 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Disturbance, Anxiety Disorder of Childhood
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 3 sitesIndia
- Study dates
- 21 May 2018to 12 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Low income Group
- Parental consent to participate in study
Who cannot join
- Disabilities
- Substance abuse
- Living outside the school areas
Trial locations and contacts
3 sites in 1 country.
India3 sites
Arsha Vidya Study Centre
Chennai, Tamil Nadu
United Research International
Jaipur, Rajasthan
NMP Medical Research Institute
Mumbai, Maharashtra
About this study
Official title: Psychological Effect of School Based-Yoga on Low-Income School Children: Randomised Controlled Trial
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.
- Being tested
- Yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
30 Min Yoga session included of Physical posture, Breathing exercise, Yoga games and Relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Yoga in School Group | Experimental | 30-mins yoga sessions were conducted in schools for 8-weeks Receives: Other: Yoga |
| Control Group | No intervention | Usual Activities in school |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Anxiety score was measured through State and Trait Anxiety Inventory
Measured: Change from baseline to 8 weeks
Secondary outcomes (2)
Depression
Depression Score was measured through Beck Depression Inventory
Measured: Changes from baseline to 8 weeks
Self Esteem
Self Esteem was measured through Rosenberg Self-esteem scale
Measured: Changes from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start21 May 2018
- Primary completion21 Dec 2018
- Study completion12 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Arsha Vidya Study Centre, United Research International
- Responsible party
- Sponsor
- Investigators
- Buddhatmananda Saraswati, Study chair, Arsha Vidya Study Centre, IndiaDivya Gaur, Study director, United Research International, IndiaRajubhai P Odedra, Principal investigator, NMP Medical Research Institute, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960944
- Sponsor's protocol ID
- NMP/UNRI
- Status last verified
- May 2019
- First submitted
- 21 May 2019
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Effect of School Based-Yoga on Low-Income School Children: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03960944
- Acronym / sponsor ID
- NMP/UNRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Arsha Vidya Study Centre, United Research International
- Study start
- 21 May 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 12 Mar 2019 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga in School Group | Experimental | Other: Yoga30-mins yoga sessions were conducted in schools for 8-weeks |
| Control Group | No intervention | –Usual Activities in school |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Low income Group
- Parental consent to participate in study
Key exclusion criteria (3 listed)
- Disabilities
- Substance abuse
- Living outside the school areas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga30 Min Yoga session included of Physical posture, Breathing exercise, Yoga games and Relaxation. | Other | Yoga in School Group |
Primary outcome
Anxiety
Time frame: Change from baseline to 8 weeks
Anxiety score was measured through State and Trait Anxiety Inventory
2 secondary outcomes
Depression
Time frame: Changes from baseline to 8 weeks
Self Esteem
Time frame: Changes from baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Buddhatmananda Saraswati study chair
Arsha Vidya Study Centre, India
Divya Gaur study director
United Research International, India
Rajubhai P Odedra principal investigator
NMP Medical Research Institute, India
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Psychological Disturbance and Anxiety Disorder of Childhood, run by NMP Medical Research Institute at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Change from baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.