| CTRI Number |
CTRI/2025/12/098274 [Registered on: 01/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Yoga Along with Usual Care for Anxiety in Children and Adolescents |
|
Scientific Title of Study
|
Yoga as an Adjunctive Intervention in Child and Adolescent Anxiety Disorders: An Open-Label Acceptability and Feasibility Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranshu Sharma |
| Designation |
Senior Resident |
| Affiliation |
PGIMER |
| Address |
Child and Adolescent Psychiatry Unit, Psychiatry Department PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
08146755835 |
| Fax |
|
| Email |
pranshutrijal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Akhilesh Sharma |
| Designation |
Additional Professor |
| Affiliation |
PGIMER |
| Address |
Department of Psychiatry, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
06239124451 |
| Fax |
|
| Email |
drakhileshsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pranshu Sharma |
| Designation |
Senior Resident |
| Affiliation |
PGIMER |
| Address |
Child and Adolescent Psychiatry Unit, Psychiatry Department PGIMER,Chandigarh
CHANDIGARH
160012
India |
| Phone |
08146755835 |
| Fax |
|
| Email |
pranshutrijal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh 160012 India |
|
|
Primary Sponsor
|
| Name |
Dr Pranshu Sharma Principal Investigator |
| Address |
Child and Adolescent Psychiatry Unit, Department of Psychiatry, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh 160012, India |
| Type of Sponsor |
Other [] |
|
|
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 Pranshu Sharma |
Child and Adolescent Psychiatry OPD and IPD, PGIMER, Chandigarh |
Room No. 224, Child and Adolescent Psychiatry OPD, Psychiatry Department PGIMER,Chandigarh
Chandigarh
CHANDIGARH |
08146755835
pranshutrijal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Treatment as usual(TAU) |
Standard clinical care for child and adolescent anxiety disorders as per department protocol. May include:
Pharmacotherapy (e.g., SSRIs, anxiolytics based on clinician decision), and/or
Psychoeducation for child and parents, and/or
Basic relaxation exercises routinely taught in clinical practice.
No structured yoga or additional behavioral module is provided in the TAU arm. |
| Intervention |
Yoga |
The yoga intervention includes the following components:
1. Breathing Practices:
o Hands Stretch Breathing, Hands In and Out Breathing, Tiger Breathing, Rab-bit Pose Breathing, Bridge Pose Breathing.
o Duration: Approximately 5 minutes per session.
2. Asanas:
o Standing Poses: Tadasana (Palm Tree Pose), Ardhachakrasana (Half Wheel Pose).
o Sitting Poses: Shashakasana (Rabbit Pose), Vajrasana (Thunderbolt Pose).
o Supine Poses: Setubandasana (Bridge Pose), Pavanamuktasana (Wind-Releasing Pose).
o Total Duration: 15 minutes.
3. Pranayama:
o Sectional Breathing, Alternate Nostril Breathing, Left Nostril Breathing, Cooling Breath.
o Duration: Approximately 12 minutes per session.
4. Meditation:
o Sound Resonance Technique (AUM Kara).
o Duration: 5 minutes.
5. Relaxation:
o Quick Relaxation Technique, Yoga Nidra.
o Duration: 8 minutes.
• Total Session Duration: 50 minutes.
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
• Children and adolescents aged 10 to 17 years.
Diagnosed with anxiety disorders as per DSM-5 criteria.
On a stable anxiolytic medication regimen for at least six weeks, if applicable.
Able to participate in yoga sessions as per protocol.
Consent provided by parent or guardian and assent obtained from participant.
Access to a multimedia device with reliable internet connectivity, if applicable for monitoring or assessments. |
|
| ExclusionCriteria |
| Details |
Presence of neurodevelopmental disorders such as intellectual disability, autism spectrum disorder, or attention-deficit hyperactivity disorder.
Diagnosis of major depressive disorder with severe impairment.
Severe psychiatric conditions including psychotic disorders or bipolar disorder.
Physical health conditions that make participation in yoga unsafe or unsuitable.
Currently undergoing structured psychological therapy.
Recent changes in psychotropic medication regimen, including initiation of new medications or dosage adjustments during the study period. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Change in anxiety symptoms as measured by a validated anxiety rating scale (such as the Spence Childrens Anxiety Scale(SCAS) and the Revised Child Anxiety and Depression Scale-Short Version(RCADS-25)) following the yoga-based intervention. |
Baseline and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To assess the intervention’s impact on depressive symptoms and dissociative symptoms.
• To assess improvement in well-being and quality of life and monitor and document any adverse effects.
|
Assessments will be carried out before the YI and at 8 weeks after the start of the yoga intervention (YI).Adverse effects will be evaluated after each YI. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/12/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pranshutrijal@gmail.com].
- For how long will this data be available start date provided 02-07-2026 and end date provided 02-07-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The proposed thesis examines the role of yoga in reducing anxiety, depressive, and dissociative symptoms in children and adolescents diagnosed with anxiety disorders. Anxiety disorders are common in this age group and significantly affect academic, social, and emotional development. Standard treatments such as cognitive behavioural therapy and pharmacotherapy are often limited by high costs, restricted access, and social stigma, leaving a large treatment gap. Yoga, which combines physical postures, breathing exercises, and mindfulness practices, has emerged as a potential adjunctive therapy. Research suggests that yoga can improve emotional regulation, lower physiological stress, and enhance overall mental well-being. However, there is little evidence from structured studies focusing on youth with anxiety disorders. This study will evaluate the feasibility, acceptability, and effectiveness of a structured yoga programme alongside standard treatment in an open-label trial. The findings are expected to guide the development of accessible, cost-effective, and culturally appropriate therapeutic options for managing anxiety and related symptoms in children and adolescents. |