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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.  

 
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