| CTRI Number |
CTRI/2023/08/056735 [Registered on: 22/08/2023] Trial Registered Prospectively |
| Last Modified On: |
18/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Biofeedback session through breathing exercise] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Deep breathing exercise on mental stress |
|
Scientific Title of Study
|
The Effect of a Brief Heart rate Variability Biofeedback session on Salivary Cortisol, Electrodermal activity and Cardiovascular reactivity to Mental stress |
| 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 Tangirala Siva Sankar Reddy |
| Designation |
Junior Resident (PG) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology
Maulana Azad Medical College
Bahadur shah zafar marg,
New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
8309106758 |
| Fax |
|
| Email |
sankarreddy1143@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mona Bedi |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology
Maulana Azad Medical College
Bahadur shah zafar marg,
New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
9990499927 |
| Fax |
|
| Email |
drmonabedi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mona Bedi |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology
Maulana Azad Medical College
Bahadur shah zafar marg,
New Delhi - 110002
DELHI
110002
India |
| Phone |
9990499927 |
| Fax |
|
| Email |
drmonabedi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College,
New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical college,
Bahadur shah zafar marg,
New Delhi - 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Tangirala Siva sankar Reddy |
Maulana Azad medical college |
Room Number 244, ANS Lab, Dept of Physiology, Pathology Block , 2nd floor
Central
DELHI |
08309106758
sankarreddy1143@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee , Maulana azad Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Heart rate variability Biofeedback |
Heart rate variability Biofeedback consists of providing an individual with real-time feedback on instantaneous heart rate, respiratory changes, and electrodermal activity while being instructed to breathe at low frequencies. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Participants with no previous exposure to HRV biofeedback and any other stress relieving techniques like yoga and meditation. |
|
| ExclusionCriteria |
| Details |
a)People with personal habits of smoking and alcohol intake.
b)Subjects who indulge in regular physical exercise.
c)Individuals with neuropsychiatric problems.
d)Individuals with Parental history of Hypertension, Diabetes Mellitus and Thyroid disorders (disease in either of the parents).
e)People with acute heart diseases and those who are equipped with pacemaker devices.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.mean of heart Rate variability before & after intervention
2.mean of salivary Cortisol levels before & after intervention
3. mean of electrodermal activity levels before & after intervention
4. cardiovascular reactivity before & after intervention which includes Blood pressure & heart rate |
Baseline & after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Blood pressure
|
Baseline & after intervention |
| Heart rate |
Baseline & after intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
31/08/2023 |
| 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="1"
Months="0"
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
|
In this Research project we aim to study the impact of a brief heart rate variability biofeedback session on salivary cortisol, electrodermal activity and cardiovascular reactivity to mental stress. The study will be conducted at Autonomic Function lab of Department of Physiology Maulana azad medical college , New Delhi. |