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CTRI Number  CTRI/2024/07/069710 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Effects of pranayam on stress levels and physical fitness of first year MBBS students at RUHS College of Medical Sciences Jaipur 
Scientific Title of Study   Evaluate the impact of pranayam on stress score and cardiorespiratory fitness among First year MBBS students at RUHS College of Medical Sciences Jaipur 
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 Smriti Srivastava 
Designation  PG STUDENT 
Affiliation  RUHS COLLEGE OF MEDICAL SCIENCES 
Address  Department of Physiology RUHS College of Medical Sciences Sector 11 road Kumbha Marg Sector 11 Pratap Nagar Jaipur

Jaipur
RAJASTHAN
302033
India 
Phone  7015884327  
Fax    
Email  smriti.srivastava.01@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sudhanshu Kacker 
Designation  SENIOR PROFESSOR 
Affiliation  RUHS COLLEGE OF MEDICAL SCIENCES 
Address  Department of Physiology RUHS College of Medical Sciences Sector 11 road Kumbha Marg Sector 11 Pratap Nagar Jaipur

Jaipur
RAJASTHAN
302033
India 
Phone  9983723535  
Fax    
Email  sudhanshukacker@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SUDHANSHU KACKER 
Designation  SENIOR PROFESSOR 
Affiliation  RUHS COLLEGE OF MEDICAL SCIENCES 
Address  Department of Physiology RUHS college of medical sciences Jaipur

Jaipur
RAJASTHAN
302033
India 
Phone  9983723535  
Fax    
Email  sudhanshukacker@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF PHYSIOLOGY RUHS COLLEGE OF MEDICAL SCIENCES SECTOR 11 ROAD KUMBHA MARG SECTOR 11 PRATAP NAGAR JAIPUR RAJASTHAN 302033 
 
Primary Sponsor  
Name  Dr SMRITI SRIVASTAVA 
Address  DEPARTMENT OF PHYSIOLOGY RUHS COLLEGE OF MEDICAL SCIENCES SECTOR 11 ROAD KUMBHA MARG SECTOR 11 PRATAP NAGAR JAIPUR RAJASTHAN 302033 
Type of Sponsor  Other [SELF] 
 
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 SMRITI SRIVASTAVA  RUHS COLLEGE OF MEDICAL SCIENCES   Department of Physiology RUHS College of Medical Sciences Jaipur
Jaipur
RAJASTHAN 
7015884327

smriti.srivastava.01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RUHS-CMS Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Kyphosis, Scoliosis,chronic bronchitis, chronic obstructive pulmonary disease, congestive heart failure, emphysema,History of major trauma, cardiothoracic surgery.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1.First MBBS students in the age group of 18-25 years voluntarily involved.
2.Students without history of major illness in past like diabetes mellitus, depression, obesity.

 
 
ExclusionCriteria 
Details  1) Subjects who participated any physical activity like yoga, exercise in past 1 year.
2) Subject having musculoskeletal disorder Kyphosis, Scoliosis
3) Subjects with any cardiopulmonary disease like chronic bronchitis, chronic obstructive pulmonary disease, congestive heart failure, emphysema
4) History of major trauma, cardiothoracic surgery.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the impact of pranayam on stress score and cardiorespiratory fitness among first year MBBS students at RUHS college of Medical Science Jaipur.

 
Assessment at baseline, 3 months and at 6 months

 
 
Secondary Outcome  
Outcome  TimePoints 
To assess and correlate VO2 max with academic related stress score,Intrapersonal and interpersonal related stress score,Teaching and learning-related stress score,Social related stress score,Drive and desire related stress score and Group activities related stress score.  1 year 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   10/07/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Stress is defined as the ‘‘wear and tear” the body experiences as it adjusts to pressure or a threating situation. Many factors can contribute to medical school being a very stressful environment. Some of those factors include: extensive curricula, numerous academic requirements, frequent, difficult and various types of examinations. High levels of stress has negative effects on the physical and mental health of medical students. Personal and environmental events that cause stress are known as stressors. Stressors of medical students generally were grouped into six categories; academic related stressors (ARS), intrapersonal and interpersonal related stressors (IRS), teaching and learning-related stressors (TLRS), social related stressors (SRS), drive and desire related stressors (DRS), and group activities related stressors (GARS). Pranayama is derived from two sanskrit words- Prana (life) or Ayama (control). Prana means an inner life force, which provides energy to different organs and control vital life processes. Ayama means voluntary effort to control and direct the prana. Pranayama involves manipulation of the breath, which is a dynamic bridge between body and mind. Breathing exercise (pranayama) for a minimum of 3 weeks are reported to influence cardiorespiratory and autonomic functions. Cardiorespiratory fitness (CRF) also referred to as aerobic capacity is one of the most important components of physical fitness. It is the ability of the body to perform dynamic, large-muscle exercise, for prolonged periods, at moderate-to high intensity. Maximum oxygen consumption (VO2max) is considered to be the most widely accepted measure of CRF giving a baseline estimate of one’s heart and lung capacity and can be used to follow the progress of daily physical exercise.

Aim:-  Evaluate the Impact of Pranayam on Stress and Cardiorespiratory Fitness among First year MBBS students at RUHS College of Medical Sciences Jaipur.

Objectives of study are:

1.      Primary Objective: To evaluate the impact of pranayam on stress score and cardiorespiratory fitness among first year MBBS students  at RUHS college

of Medical Science Jaipur at baseline, three month and six month.

 

 

2.      Secondary objective:

  • ·     To assess and correlate VO2 max with  academic related stress score (ARS)

at baseline, three months and six months after pranayam intervention.

  • ·        To assess and correlate VO2 max with Intrapersonal and interpersonal related stress score (IRS) at baseline, three months and six months after pranayam intervention.
  • ·         To assess and correlate VO2 max with Teaching and learning-related stress score (TLRS)

at baseline, three months and six months after pranayam intervention.

  • ·         To assess and correlate VO2 max with Social related stress score (SRS)

at baseline, three months and six months after pranayam intervention.

  • ·         To assess and correlate VO2 max with Drive and desire related stress score (DRS)

at baseline, three months and six months after pranayam intervention.

  • ·         To assess and correlate VO2 max with Group activities related stress score (GARS)

at baseline, three months and six months after pranayam intervention.

  • ·         To assess and correlate academic related stressors (ARS), intrapersonal and interpersonal related stressors (IRS), teaching and learning-related stressors (TLRS), social related stressors (SRS), drive and desire related stressors (DRS), and group activities related stressors (GARS) at baseline, three months and at six months.

 

·   

METHODS:-

1. Study design: Observational type

2. Study place: Department of physiology at RUHS College of Medical Sciences, Jaipur.

3. Study Universe: All first year MBBS students of either sex from RUHS College of Medical Sciences, Jaipur.

4. Study population: First year MBBS students of either sex, shall be included from RUHS college of Medical Sciences Jaipur who will given written informed consent form.

5. Study duration: 1 year

  Data collection: 8 month

  Data analysis: 4 month

6. Sample size:  Out of 150 students who will give written informed consent form.

7. Inclusion criteria:

 A) First MBBS students in the age group of 18-25 years voluntarily involved.

B) Students without history of major illness in past like diabetes mellitus, depression, obesity.

8. Exclusion criteria:

A) Subjects who participated any physical activity like yoga, exercise in past 1 year.

B) Subject having musculoskeletal disorder Kyphosis, Scoliosis

C) Subjects with any cardiopulmonary disease like chronic bronchitis, chronic obstructive pulmonary disease, congestive heart failure, emphysema

D) History of major trauma, cardiothoracic surgery.

 

INTERVENTION

We will give pranayam training. Students will perform the pranayama in the morning for 30 minutes, six days in a week, for 24 weeks under expert’s observation. Data collection will be done at baseline, three months and six months of pranayam.

 

CARDIORESPIRATORY FITNESS:- We will asses cardiorespiratory fitness by VO2max. For determination of VO2max we are here using direct method AD Instrument Gas analyzer (model-ML206)

 

QUESTIONNAIRE: Medical Student Stressor Questionnaire (MSSQ) for stress score and Global physical activity questionnaire (GPAQ) for assessment of physical activity will be use at baseline, three months and after six months of pranayam intervention.

 

We are performing this study to evaluate the impact of Pranayam on Stress and Cardiorespiratory Fitness among First year MBBS students at RUHS College of Medical Sciences Jaipur.

 
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