CTRI Number |
CTRI/2025/04/084240 [Registered on: 07/04/2025] Trial Registered Prospectively |
Last Modified On: |
05/04/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) Other (Specify) [neurofeedback therapy ] |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Assess effect of Alpha Binaural rhythm and acupressure alone and in combination, on the autonomic functions, in hypertensive patients |
Scientific Title of Study
|
Comparative study to evaluate the impact of Alpha Binaural Rhythm and Acupressure on Autonomic Functions in patients with hypertension – A Randomised Trial |
Trial Acronym |
HIBA |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Madhuri Taranikanti |
Designation |
Additional professor |
Affiliation |
All India Institute of Medical Sciences, Bibinagar |
Address |
Dept of Physiology, AIIMS, Bibinagar (Hyderabad metropolitan Region), District Yadadri Bhuvanagiri
Hyderabad TELANGANA 508126 India |
Phone |
8008366030 |
Fax |
|
Email |
madhuri.tarani@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Madhuri Taranikanti |
Designation |
Additional professor |
Affiliation |
All India Institute of Medical Sciences, Bibinagar |
Address |
Dept of Physiology, AIIMS, Bibinagar (Hyderabad metropolitan Region), District Yadadri Bhuvanagiri
TELANGANA 508126 India |
Phone |
8008366030 |
Fax |
|
Email |
madhuri.tarani@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Madhuri Taranikanti |
Designation |
Additional professor |
Affiliation |
All India Institute of Medical Sciences, Bibinagar |
Address |
Dept of Physiology, AIIMS, Bibinagar (Hyderabad metropolitan Region), District Yadadri Bhuvanagiri
TELANGANA 508126 India |
Phone |
8008366030 |
Fax |
|
Email |
madhuri.tarani@gmail.com |
|
Source of Monetary or Material Support
|
All India Institute of Medical Sciences, Bibinagar, (Hyderabad Metropolitan Region), Dist Yadadari Bhuvanagiri, Telangana, India -508126 |
|
Primary Sponsor
|
Name |
All India Institute of Medical Sciences Bibinagar |
Address |
AIIMS, Bibinagar (Hyderabad metropolitan Region), District Yadadri Bhuvanagiri,Telangana, India 508126 |
Type of Sponsor |
Research institution and hospital |
|
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 Madhuri Taranikanti |
All India Institute of Medical Sciences, Bibinagar |
Dept of Physiology, AIIMS, Bibinagar (Hyderabad metropolitan Region), District Yadadri Bhuvanagiri Hyderabad TELANGANA |
8008366030
madhuri.tarani@gmail.com |
Dr Farheen Fatima |
ESIC Medical College Hyderabad |
7-1-634, Survey No 121/1 and 121/2, National Highway 65 Sanjeeva Reddy Nagar, Sanath Nagar, Hyderabad, Telangana 500038 Hyderabad TELANGANA |
9866210424
farheen.acad87@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Submittted/Under Review |
Institutional Ethics Committee (AIIMS BBN-IEC) |
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 |
Intervention |
Alpha binaural beats + acupressure points stimulation intervention |
Alpha Binaural Beats and Acupressure 3 Point Stimulation Intervention for 6 minutes |
Intervention |
Alpha binaural beats intervention |
Participants will be seated with eyes closed and listen to alpha binaural beats using head/ear phones for 6 minutes. |
Intervention |
GV 20, LI4 and GB20 accupressure stimulation |
Participants will receive acupressure stimulation at the GV 20, LI4 and GB20 acupressure points (located at the vertex of the head, between thumb and index finger and back of the neck) for a total duration 6 minutes (2 minutes at each point) |
Comparator Agent |
standard care for hypertension |
standard care for hypertension |
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Staff of the AIIMS Bibinagar and ESIC Medical College & Hospital, Hyderabad with history of hypertension belonging to both genders
BP more than equal to 140 and 90 mm Hg
Age between 25-60 years
BMI less than 25
Willingness to participate and provide informed consent
PSS cutoff 19 and above scores |
|
ExclusionCriteria |
Details |
History of neurological disorders, endocrine disorders, malignancy, coronary artery disease, stroke, psychiatric disorders, metabolic disorders, obesity, hearing deficits, , kidney disoders, hypercholesterolemia
Patients of hypertension on beta blockers, Calcium channel blockers
Pregnancy or lactation.
Those with a formal training in music
Regular Practitioners of any other alternate therapies like yoga and meditation |
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Effect of alpha binaural rhythm administration and accupressure point stimulation (GV20, LI4 and GB20) independently and in combination on autonomic function parameters and perceived stress levels among hypertensive individuals |
0 and 4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Variations in the levels of blood pressure, autonomic function parameters including heart rate variability (HRV), electrodermal response (EDR), photoplethysmography (PPG), and beat-to-beat blood pressure variability along with EEG before and after intervention between the intervention groups and the control group |
0 and 4 weeks |
|
Target Sample Size
|
Total Sample Size="88" Sample Size from India="88"
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)
|
05/05/2025 |
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="0" 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
|
Hypertension presents a significant health
challenge affecting individuals across various demographics and professions. Chronic
stress, a common consequence of the occupational demands, is intricately linked
to hypertension through its influence on the autonomic nervous system and the
hypothalamic-pituitary-adrenal (HPA) axis. Any dysregulation of these
physiological pathways can result in a disruption of autonomic functions,
elevation in stress hormones levels and alterations in cardiovascular function.
Previous studies have explored the effects of alpha
binaural beats and acupressure on stress and autonomic function in various
populations independently with varied outcomes. There exists a paucity of literature
regarding the effect of combination of these intervention therapies in this
regard. To the best of our knowledge, this is the first study to address this knowledge
gap and investigate the effects of alpha binaural beats and acupressure point
stimulation with GV 20 individually and in combination on stress levels and
autonomic function parameters in hypertensive individuals. This will be a multicentric
study, where 88 participants will be recruited as per the inclusion and exclusion
criteria and block randomized into four predefined groups (3 intervention and 1
control). All the interventions will be carried out as per the protocol in each
group. The parameters like Perceived Stress Scale (PSS)- Questionnaire
assessing perceived stress levels, GAD-7, Blood pressure, Autonomic Function
Parameters (including Heart Rate Variability (HRV) – LF, HF Power, RMSSD, LF/HF
ratio, Electrodermal Response (EDR), Photoplethysmography (PPG), Beat-to-beat
Blood Pressure and Electroencephalography (EEG) will be recorded at 0 and 4
weeks post intervention. Appropriate statistical analysis will be carried out
to analyze the data collected and summarize the results obtained. |