| CTRI Number |
CTRI/2024/07/069972 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Pranayama on Stress during Blood Donations |
|
Scientific Title of Study
|
Effect of Pranayama on Physiological, Biochemical and Psychological Stress-Anxiety Response Patterns in Whole Blood Donors at Risk of Vasovagal Reaction at a Tertiary Care Centre: An Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Umesh Kumar Singh |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Department of Transfusion Medicine
AIIMS, Rishikesh
Veerbhadra Marg, Rishikiesh
Dehradun
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9634772914 |
| Fax |
|
| Email |
umeshaiims2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Umesh Kumar Singh |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Department of Transfusion Medicine
AIIMS, Rishikesh
Veerbhadra Marg, Rishikiesh
Dehradun
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9634772914 |
| Fax |
|
| Email |
umeshaiims2013@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Jain |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Department of Transfusion Medicine
AIIMS, Rishikesh
Veerbhadra Marg, Rishikiesh
Dehradun
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9917817515 |
| Fax |
|
| Email |
ashish.jain.modi@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Veerbhadra Marg, Rishikesh, District- Dehradun, Uttarakhand, India
PIN: 249203 |
|
|
Primary Sponsor
|
| Name |
Dr Umesh Kumar Singh |
| Address |
Department of transfusion Medicine, All India Institute of Medical Sciences, Veerbhadra Marg, Rishikesh, District- Dehradun, Uttarakhand, India PIN: 249203 |
| Type of Sponsor |
Other [Invstigator is the primary sponser] |
|
|
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 Umesh Kumar Singh |
All India Institute of Medical Sciences, Rishikesh |
Room no.201, Blood Bank, All India Institute of Medical Sciences, Veerbhadra Marg, Rishikesh, District- Dehradun, Uttarakhand, India PIN: 249203
Dehradun
UTTARANCHAL |
9634772914
umeshaiims2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy blood donors |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alternate Nostril Yogic Breathing and Left nostril Yogic Breathing for 10 minutes |
Effect of Pranayama on Physiological, Biochemical and Psychological Stress-Anxiety Response Patterns in Whole Blood Donors at Risk of Vasovagal Reaction |
| Comparator Agent |
healthy blood donors without pranayama |
Assessing Physiological, Biochemical and Psychological Stress-Anxiety Response Patterns in Whole Blood Donors at Risk of Vasovagal Reaction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1- Donors meeting the criteria of blood donation laid down by the Government of India Under the Drug and Cosmetic Rules 1945 (Amendment 2020) and Blood donors at risk vasovagal reaction.
a. Donors with prior history of Vasovagal reaction
b. Donors having overt apprehension or anxiety
c. Family donors whose first-degree relative is admitted in the hospital
d. First time donors
e. Female donors
f. Donors who slept in the hospital the previous night
g. Young donors (Age group 18-25 years)
2- Donors willing to be part of the study
|
|
| ExclusionCriteria |
| Details |
Donors not willing to be part of the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in blood pressure, heart rate variability, galvanic stimulation response, anxiety status, and serum cortisol levels in whole blood donors at risk of vasovagal reaction after giving a session of 10 minutes of pranayama with the control group. |
1. At baseline
2. After Blood donation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify various risk factors for the vasovagal reaction in the donor population. |
Post Donation |
|
|
Target Sample Size
|
Total Sample Size="424"
Sample Size from India="424"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/07/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Blood donors visiting the blood centre of the Department of Transfusion Medicine to donate blood will be enrolled in this study using the inclusion criteria of the study. The pre-donation psychological stress-anxiety will be evaluated by questionnaire. The physiological stress anxiety will be evaluated by AD ( Analog and Digital ) instruments along with LabChart software and a sample will be taken for measuring cortisol level to evaluate biochemical parameter in study group with intervention given and also in control group that is whole blood donors not given any intervention.After this, these donors will be allocated in either study group or control group in a continuous sampling. In the study group, intervention in the form of Pranayama will be given for 10 minutes while in the control group, the donors will be rested for 10 minutes only. After 10 minutes, donors of both the groups will undergo blood donation. The physiological parameter will also be evaluated during blood donation. Twenty minutes after the blood donation, the same psychological, physiological and biochemical parameters will be evaluated from the donors of both the groups. The donors of both groups will also be observed for vasovagal reaction if any.The observer (Nursing staff and the doctor present in the blood donation room will be blinded. The intervention will be given in pre-donation room by the investigator |