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
|
|
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
|
|
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. |