Assess effect of Alpha Binaural rhythm and acupressure alone and in combination, on the autonomic functions, in hypertensive patients

Not yet recruiting

Conditions: Essential (primary) hypertension,

Registration Number: CTRI/2025/04/084240

Lead Sponsor: All India Institute of Medical Sciences Bibinagar

Brief Summary: Hypertension presents a significant healthchallenge affecting individuals across various demographics and professions. Chronicstress, a common consequence of the occupational demands, is intricately linkedto hypertension through its influence on the autonomic nervous system and thehypothalamic-pituitary-adrenal (HPA) axis. Any dysregulation of thesephysiological 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 alphabinaural beats and acupressure on stress and autonomic function in variouspopulations independently with varied outcomes. There exists a paucity of literatureregarding the effect of combination of these intervention therapies in thisregard. To the best of our knowledge, this is the first study to address this knowledgegap and investigate the effects of alpha binaural beats and acupressure pointstimulation with GV 20 individually and in combination on stress levels andautonomic function parameters in hypertensive individuals. This will be a multicentricstudy, where 88 participants will be recruited as per the inclusion and exclusioncriteria and block randomized into four predefined groups (3 intervention and 1control). All the interventions will be carried out as per the protocol in eachgroup. The parameters like Perceived Stress Scale (PSS)- Questionnaireassessing perceived stress levels, GAD-7, Blood pressure, Autonomic FunctionParameters (including Heart Rate Variability (HRV) – LF, HF Power, RMSSD, LF/HFratio, Electrodermal Response (EDR), Photoplethysmography (PPG), Beat-to-beatBlood Pressure and Electroencephalography (EEG) will be recorded at 0 and 4weeks post intervention. Appropriate statistical analysis will be carried outto analyze the data collected and summarize the results obtained.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 88

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (2): All India Institute of Medical Sciences, Bibinagar
🇮🇳
Hyderabad, TELANGANA, India
ESIC Medical College Hyderabad
🇮🇳
Hyderabad, TELANGANA, India
All India Institute of Medical Sciences, Bibinagar
🇮🇳Hyderabad, TELANGANA, India
Dr Madhuri Taranikanti
Principal investigator
8008366030
madhuri.tarani@gmail.com