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CTRI Number  CTRI/2024/10/075710 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Preventive 
Study Design  Other 
Public Title of Study   Short Yogic breathing module for mental health of adolescents 
Scientific Title of Study   Development, validation and feasibility testing of short yogic breathing module for depression, anxiety, stress and sleep quality of school-going adolescents 
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 Naveen K H 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Community Medicine and Family Medicine, Room no. 212, 2nd floor, Medical College building, Basni phase 2

Jodhpur
RAJASTHAN
342005
India 
Phone  9980030138  
Fax    
Email  naveenkhdoc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Naveen K H 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Community Medicine and Family Medicine, Room no. 212, 2nd floor, Medical College building, AIIMS, Basni phase 2

Jodhpur
RAJASTHAN
342005
India 
Phone  9980030138  
Fax    
Email  naveenkhdoc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Naveen K H 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Community Medicine and Family Medicine, Room no. 212, 2nd floor, Medical College building, AIIMS, Basni phase 2

Jodhpur
RAJASTHAN
342005
India 
Phone  9980030138  
Fax    
Email  naveenkhdoc@gmail.com  
 
Source of Monetary or Material Support  
This is a Non-funded project. Hence, there is no funder or funding agency for monetary support 
 
Primary Sponsor  
Name  Not Applicable 
Address  Non funded 
Type of Sponsor  Other [Non funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Naveen K H  AIIMS Jodhpur  Department of Community Medicine and Family Medicine, Room no. 212, 2nd floor, Medical College building, Basni phase 2
Jodhpur
RAJASTHAN 		 9980030138

naveenkhdoc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  School going adolescents who are normal or having mild to moderate levels of depression, anxiety and stress  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  None  this is a development, validation, and feasibility testing study. Hence, after development and validation of the module, feasibility will be assessed using pre-post design. Hence there is no comparator in this study 
Intervention  Yoga  Yogic breathing module Duration of intervention is 4 weeks- feasibility testing 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  l. School-going adolescents
2. Those who give assent and parental consent
3. The adolescents with normal, mild-moderate scores on DASS Y 
 
ExclusionCriteria 
Details  l. Those with known chronic illness, like asthma, psychiatric illness
2. Those with severe degrees of depression, anxiety and stress
3. The institutes which do not permit to conduct the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Development of yogic breathing module, and its validation with experts. Feasibility of delivering the yogic breathing module among school-going adolescents. ease of practice, subjective feeling of relaxation (physical and mental) using visual analogue
scale (VAS), pain or discomfort on VAS scale 		 Baseline and at the end of 4 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
No. of students with normal, mild, moderate, and severe scores on DASS-Y, and poor sleep quality on PSQI. Anthropometry, Spo2, HR, RR  8 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   29/10/2024 
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="8"
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [naveenkhdoc@gmail.com].

  6. For how long will this data be available start date provided 25-04-2025 and end date provided 25-04-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Rationale of the study supported by cited literature:

Existing yoga techniques include 45-minute to hour-long sessions, which may not be feasible for regular practice. The strength of the short 20-25 mins yogic breathing module lies in its short duration and easy-to-learn practices. The short yogic breathing module can be implemented in daily practice. Thus, our current study aims to develop and validate and test the feasibility of a short (20-25 mins) yogic breathing module that may reduce depression, anxiety and stress, and sleep quality.

  

Hypothesis:

Null hypothesis: The short (20-25 minutes) yogic breathing module is not valid and not feasible to address the depression, anxiety, stress, and sleep quality of school-going adolescents

Alternative hypothesis: The short (20-25 minutes) yogic breathing module is valid and feasible to address the depression, anxiety, stress, and sleep quality of school-going adolescents

 

Research questions:

Is the short yogic breathing module valid and feasible to address the depression, anxiety, stress, and sleep quality of school-going adolescents?

 

Aims and Objectives:

Aim:

To develop, validate and test the feasibility of a short yogic breathing module to address depression, anxiety and stress, and sleep quality of  school-going adolescents

 

Objective:

1.To develop a short (20-25 minutes) yogic breathing module to address Depression, Anxiety, Stress and Sleep Quality of School-going Adolescents.

2. To validate the developed  yogic breathing module with the experts

3. To assess the feasibility of training school-going adolescents and their teachers in the Yogic breathing module


Detailed methodology:

1. Development of short yogic breathing module:

An extensive review of the latest literature on yoga practices suitable for school-going adolescents, for addressing  depression, anxiety and stress, and sleep quality will be done. A structured 20-25 minutes yogic breathing module tailored to the needs and capabilities of school adolescents, incorporating findings from the literature review by referring to traditional yogic texts, scriptures, discussions with experts in yoga will be developed. We will be collaborating  with experienced yoga instructors with at least 10 years of experience to refine and optimise the yogic breathing module, ensuring it meets the standards of safety, effectiveness, and appropriateness for the target audience.(2)

2. Validation of short yogic breathing module:

We will be identifying a panel of subject experts comprising yoga practitioners/experts, psychologists, educators, and healthcare professionals/clinicians with expertise in adolescent development and yoga. The items of the developed short yogic breathing will be entered on the google form. Each item will be provided with choices on Likert scale. The google form will be shared with subject experts with a request to rate each item of the module on a Likert scale. Based on the responses the Content Validity ratio will be calculated to assess the degree of agreement among the subject experts regarding the appropriateness of the yogic breathing module. Refinement of the module will be done based on the feedback received to improve its content validity .(3)

3. Feasibility Assessment:

The validated short yogic breathing module will be performed by a trained yoga instructor and video recorded. A representative sample of 20 school going adolescents will be enrolled after informed assent and consent from the parents. The short yogic breathing module will be implemented in each selected school, ensuring adherence to the prescribed guidelines and protocols. Pre assessment will be done by using the DASS Y, PSQI scales . Post assessment will done after four weeks with DASS Y , PSQI scales along with Yoga performance scale (YPA) scale, ease of practice, subjective feeling of relaxation (physical and mental) using visual analogue scale (VAS), pain or discomfort on VAS scale. It is also proposed to collect quantitative and qualitative data on the feasibility of the yoga module, including factors such as availability of resources, space, time constraints, instructor expertise, student engagement, and administrative support. Collected data will be analysed to assess the practicality, acceptability, and sustainability of integrating the yogic breathing module into the school curriculum. Further, any challenges or barriers encountered during implementation will be identified and recommendations for addressing them effectively will be proposed.(4)

4. Checking the Feasibility in 20 Students:

Pilot Implementation: Conduct a pilot implementation of the yoga module in the selected 20 students, monitoring its delivery and reception among students and school staff. Gather feedback from students, teachers, and administrators through surveys, interviews, and observations to evaluate the feasibility and scalability of the yoga module across different school settings. Compare the experiences and outcomes across the 20 students to identify common trends, variations, and best practices for implementing the yoga module effectively.

 

 
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