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CTRI Number  CTRI/2023/05/053150 [Registered on: 26/05/2023] Trial Registered Prospectively
Last Modified On: 11/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Postural exercises and perceived distress among under graduate students of health professions Program. 
Scientific Title of Study   Effect of Postural exercises on Psychological and Biological markers of perceived distress among under graduate students of health professions Program. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR R Harihara Prakash 
Designation  Professor 
Affiliation  K M Patel Institute of Physiotherapy 
Address  Opd no-152, Physiotherapy department, K M Patel Institute of Physiotherapy Bhaikaka University, Shree Krishna Hospital, Karamsad

Anand
GUJARAT
388325
India 
Phone  8238238685  
Fax    
Email  hariharap@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Ashish Gupta 
Designation  Associate Professor 
Affiliation  K M Patel Institute of Physiotherapy, Karamsad, District - Anand, State - Gujarat 
Address  Opd no-152, Physiotherapy department, K M Patel Institute of Physiotherapy Bhaikaka University, Shree Krishna Hospital, Karamsad

Anand
GUJARAT
388325
India 
Phone  09925048223  
Fax    
Email  ashishvg@charutarhealth.org  
 
Details of Contact Person
Public Query
 
Name  Ashish Gupta 
Designation  Associate Professor 
Affiliation  K M Patel Institute of Physiotherapy, Karamsad, District - Anand, State - Gujarat 
Address  Opd no-152, Physiotherapy department, K M Patel Institute of Physiotherapy Bhaikaka University, Shree Krishna Hospital, Karamsad

Anand
GUJARAT
388325
India 
Phone  09925048223  
Fax    
Email  ashishvg@charutarhealth.org  
 
Source of Monetary or Material Support  
OPD no. 152, Department: Physiotherapy, K M Patel Institute of Physiotherapy, Bhaikaka University, Shree Krishna Hospital, Karamsad-388325, Anand, Gujarat, India 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 R Harihara Prakash  K M Patel Institute of Physiotherapy   OPD no. 152, Department: Physiotherapy, K M Patel Institute of Physiotherapy, Bhaikaka University, Shree Krishna Hospital, Karamsad-388325, Anand, Gujarat, India Anand GUJARAT
Anand
GUJARAT 
8238238685

hariharap@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-2, Bhaikaka University, Karamsad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  students of health professions education having stress, burnout and anxiety  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional program  Jacobson’s Progressive muscle relaxation for 2 weeks 
Intervention  Postural exercise program  postural exercises program along with Jacobson’s Progressive muscle relaxation for 2 weeks 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  23.00 Year(s)
Gender  Both 
Details  Undergraduate students of any of Health Professional Program viz. Physiotherapy, MBBS, Nursing and Medical laboratory technology from constituent institutes of Bhaikaka University and willing to participate in study 
 
ExclusionCriteria 
Details  Participants who are already diagnosed case of Psychiatric illness and on Psychiatric medication.

Participants with history of physical disorders and systemic illness for which they are under any standard of medical care that can limit their participation for postural exercises.

Participants who are already doing YOGA or Postural exercise. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Perceived Stress Scale (PSS)  2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
State-Trait Anxiety Inventory (STAI), Maslach Burnout Inventory (MBI), Rosenberg Self-Esteem Scale, Blood cortisol level, Heart rate variability  2 weeks 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   01/06/2023 
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="2"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Plenty of literature has demonstrated the higher prevalence of stress, anxiety and burnout among students of health profession education. Majority of literature has only assessed the level of psychological stress in university students but there is dearth of literature which states about managing these problems. In the recent era, considering the higher prevalence of psychological distress among students, majority of the schools and colleges have special cells where students can report such issues or events. However, majority of the students do not opt for such services considering it a social stigma. This creates the need of some new intervention to manage such problems in university students. Emotion and mental attitude have profound effect upon the nervous system as a whole. Depressed and Anxious individuals tend to have slower gait, slumped posture, and less steadiness when walking than normal individuals. Joy, Winning, Happiness, Success and confidence are stimulating and are reflected by an alert posture in which position of extension predominates. Conversely, Unhappiness, Conflict, feeling looser and inferiority have just the opposite effect and result in postures in which positions of flexion are conspicuous. The persistent feeling of worries, sadness or loss of interest that characterises anxiety and major depression can lead to chronic postural changes. It is certain that the mental attitude affects the physical, either temporarily or permanently. Is it not possible that this can also happen in reverse? Can not a physical attitude adopted consciously affect the mental attitude?  This phenomenon (Posture changes in anxiety and stress) is neither well studied in context of physiotherapy nor any treatment protocol addresses the need of posture exercise program in treatment of stress, anxiety which includes awareness about posture, relation between mind and posture, power pose, body expansion postural exercises in different positions, which is very safe, easy to perform without any harm and can be incorporate in daily life easily.
 
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