| CTRI Number |
CTRI/2025/11/097734 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Slow breathing and heart-rate biofeedback for improving blood pressure and mental abilities in people with hypertension. |
|
Scientific Title of Study
|
Effects of Biofeedback and Coherent Breathing on
Autonomic and Cognitive Function in Hypertensive
Adults: A Randomized Controlled Trial |
| 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 Subodh Pandey |
| Designation |
Professor & Head |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Department of Physiology, Gandhi Medical College, Sultania Road, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9406511402 |
| Fax |
|
| Email |
subodhpandey97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subodh Pandey |
| Designation |
Professor & Head |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Department of Physiology, Gandhi Medical College, Sultania Road, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9406511402 |
| Fax |
|
| Email |
subodhpandey97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gourav Singh Raghuwanshi |
| Designation |
Junior Resident |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Department of Physiology, Gandhi Medical College, Sultania Road, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8447090731 |
| Fax |
|
| Email |
gourav.link@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Subodh Pandey |
| Address |
Department of Physiology, Gandhi Medical College, Bhopal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gourav Singh Raghuwanshi |
Hamidia Hospital |
Cardiology Research Lab, Cardiology Department, 11th Floor, Hospital Block 1
Bhopal
MADHYA PRADESH |
8447090731
gourav.link@gmail.com |
| Dr Subodh Pandey |
Hamidia Hospital |
Neurophysiology lab, Physiology department, 2nd floor, Gandhi medical college, Hamidia hospital Campus
Bhopal
MADHYA PRADESH |
9406511402
subodhpandey97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Gandhi Medical College, Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Group C (Control): Eyes-open quiet rest, 10 minutes, no feedback or breathing instructions. |
| Intervention |
Heart Rate Biofeedback |
Group A (Heart Rate Biofeedback): 10-minute session using BIOPAC MP160 system with real-time heart rate feedback (visual bar-graph). |
| Intervention |
Slow Coherent Breathing |
Group B (Slow Coherent Breathing): 10-minute nasal, diaphragmatic breathing at 6 breaths/min, guided by audio metronome (5s in/5s out). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed with Stage I or Stage II hypertension (SBP 130–179 mmHg or DBP 80–119 mmHg).
2. Either untreated or on a stable antihypertensive regimen for more than 4 weeks.
3. Willing and able to provide informed consent and comply with study procedures. |
|
| ExclusionCriteria |
| Details |
1. Secondary hypertension.
2. Diabetes mellitus (HbA1c less than 6.5%).
3. Major organ dysfunction (renal, hepatic, or cardiac failure).
4. History of stroke, epilepsy, dementia, schizophrenia, or bipolar disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Systolic Blood Pressure (SBP, mmHg) measured immediately post-intervention compared to baseline. |
Baseline and Post-intervention/control |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Autonomic function: Heart Rate Variability indices (RMSSD, LF/HF ratio). |
Baseline, during intervention and after intervention |
| Cognitive function: Stroop Task (interference score, accuracy); SART (commission and omission errors) |
Baseline and Post-intervention/control |
| Psychological measures: Perceived Stress Scale (PSS-10), Visual Analogue Scales (calmness, attention) |
Baseline and Post-intervention/control |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/12/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This randomized controlled trial will evaluate the immediate effects of heart rate biofeedback and slow coherent breathing on blood pressure, autonomic function (heart rate variability), and cognitive function in adults with Stage I or II hypertension. Ninety participants will be randomized into three groups: HR biofeedback, coherent breathing, and control (quiet rest). Primary outcome is change in systolic blood pressure post-intervention; secondary outcomes include HRV, Stroop/SART task performance, and subjective stress and calmness. The study aims to clarify the role of non-pharmacological autonomic modulation strategies in hypertension management. |