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CTRI Number  CTRI/2021/07/034521 [Registered on: 02/07/2021] Trial Registered Prospectively
Last Modified On: 28/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   to study impact of yog nidra and music therapy on sleep quality, mental health and global well being of recently recovered hospitalised covid-19 patients 
Scientific Title of Study   To study the impact of Yog nidra and music therapy on the sleep quality, mental health and global well being of the population recently recovered from COVID-19: A Randomised controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VIKRAM JAIN 
Designation  JUNIOR RESIDENT 
Affiliation  AIIMS RISHIKESH 
Address  department of general medicine level 6, AIIMS RISHIKESH, Rishikesh.
room no.414, PG hostel 84, Aiims rishikesh, rishikesh
Dehradun
UTTARANCHAL
249201
India 
Phone  7737279655  
Fax    
Email  vikramjetawat99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  MONIKA PATHANIA 
Designation  CONSULTANT 
Affiliation  AIIMS RISHIKESH 
Address  DEPARTMENT OF GENERAL MEDICINE, LEVEL 6 AIIMS RISHIKESH, UTTARAKHAND

Dehradun
UTTARANCHAL
249201
India 
Phone  8126021556  
Fax    
Email  anshupathania27@gmail.com  
 
Details of Contact Person
Public Query  
Name  MONIKA PATHANIA 
Designation  CONSULTANT 
Affiliation  AIIMS RISHIKESH 
Address  DEPARTMENT OF GENERAL MEDICINE, LEVEL 6 AIIMS RISHIKESH, UTTARAKHAND

Dehradun
UTTARANCHAL
249201
India 
Phone  8126021556  
Fax    
Email  anshupathania27@gmail.com  
 
Source of Monetary or Material Support  
AIIMS RISHIKESH 
 
Primary Sponsor  
Name  AIIMS RISHIKESH 
Address  Virbhadra Road Shivaji Nagar, near Barrage, Sturida Colony, Rishikesh, Uttarakhand 249203 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
MONIKA PATHANIA  DEPARTMENT OF GENERAL MEDICINE LEVEL 6 AIIMS RISHIKESH, RISHIKESH 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
VIKRAM JAIN  AIIMS RISHIKESH  DEPARTMENT OF GENERAL MEDICINE, LEVEL 6
Dehradun
UTTARANCHAL 		 7737279655

vikramjetawat99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE AIIMS RISHIKESH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B338||Other specified viral diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  To compare the effect of yog nidra and music therapy on the sleep quality, mental health and global wellbeing of the patients recovered from covid-19  Subjects in the third arm will continue to take their routine standard of care without receiving any intervention. Patients in all the arms will be continued on standard care of treatment and no modification in their ongoing treatment if any will be done. Yog nidra and music therapy will be adding on to their ongoing treatment.  
Intervention  To compare the effect of yog nidra and music therapy on the sleep quality, mental health and global wellbeing of the patients recovered from covid-19.  Participant recruitment will be done using consecutive sampling method, at the respective OPD aiims, Rishikesh. Eligible participants will be allocated to three arms (ratio 1:1:1) with the help of computer generated randomized sequence. The random allocation sequence will be generated by a third person with no clinical involvement ensuring unpredictable allocation sequence. All the participants will be randomised and the allocated group will be given in a concealed fashion sequentially numbered opaque sealed envelopes (snose). Envelopes will contain a small sheet of aluminium foil in order to make them impermeable to intense/immense light. Envelopes will be opened sequentially and only after writing participant’s name and other details in order to remove any chance of selection bias. All the participants will be divided in 3 groups. All subjects in first group will receive yog nidra, in the second group will receive music therapy(mt) sessions and third group will get placebo only. yog nidra- the online version of yog nidra will be delivered by at least one certified volunteer of SSIAR, with at least one back up teacher at all times. The online version of yog nidra for all the participants has a total duration of 30 minutes every day for 30 days total. These sessions will be given via zoom application. There will not be any funds involved in this. music therapy (mt)- online music therapy sessions will be provided by a certified volunteer from SSIAR. Participants will be given 30 min of music therapy session daily for a period of 30 days total. There will not be any funds involved in this. All the mt sessions will be delivered online via zoom application. participants with less than 75% days of compliance to intervention will be excluded from study.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ● 40 years to 60 years of age both genders
● History of being covid positive who have been recovered and discharged from Aiims Rishikesh with more than 5 days of hospitalisation within 6 months duration.
● Patient with PSQI more than 5, who wellbeing index less than 40.
● Participants who are having smartphone, internet connection and zoom application.
● Willing to commit to regular yog nidra and music therapy sessions at home
 
 
ExclusionCriteria 
Details  ● Pregnant women
● Patients unable to understand instructions.
● Patients not willing to attend more than 75 percent of sessions
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome for this study will be compare the impact on mental health, sleep quality and global wellbeing between all 3 groups  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
respective group assessment  30 days 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   25/07/2021 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   COVID -19 has caused not only great public concern but also brought huge psychological distress, especially in patients recently recovered from this infection.
A large number of population who has suffered from the disease and facing psychological challenges have been overlooked. 
recent studies have shown benefits of yog nidra and music therapy sessions in prevention and treatment of PTSD with significant result but their is no study which showed benefit in sleep quality, mental health and overall well being of recent covid-19 recovered patients.
hypothesis- yog nidra and music therapy sessions can improve sleep quality, mental health and global well being of recently recovered hospitalized covid-19 patients.
 
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