The Use of Virtual Reality and Music Therapy for Hypertensive Urgency

May 1, 2026 updated by: Safa Dönmez, Ankara City Hospital Bilkent

Effect of Virtual Reality and Classical Music Therapy on Blood Pressure and Anxiety in Patients With Hypertensive Urgency

This study aims to evaluate whether virtual reality (VR) and classical music therapy, when added to standard antihypertensive treatment, can improve blood pressure control and reduce anxiety in patients presenting to the emergency department with hypertensive urgency. Patients with primary hypertension and no signs of end-organ damage will be randomly assigned to receive either standard treatment alone or standard treatment combined with VR and classical music. Blood pressure will be monitored at multiple time points over a 120-minute period, and anxiety will be assessed using the State Anxiety Inventory (STAI-I). The study seeks to determine if these non-pharmacological interventions can enhance the effectiveness of routine management of hypertensive urgency.

Study Overview

Detailed Description

Hypertensive urgency is characterized by severely elevated blood pressure without evidence of acute target-organ damage. Standard management typically involves the gradual reduction of blood pressure using oral antihypertensive agents such as captopril. Emotional stress and anxiety can contribute to elevated sympathetic activity, potentially worsening blood pressure control. Virtual reality (VR) environments and classical music therapy have been shown in prior studies to reduce stress, improve patient comfort, and modulate physiological responses.

In this randomized controlled study, patients with primary hypertension who present to the emergency department with hypertensive urgency will be assigned to one of two groups: standard pharmacological treatment alone or standard treatment combined with VR exposure and classical music therapy. The intervention will be delivered in a quiet and dimly lit room, and blood pressure will be measured at predefined intervals over 120 minutes. Anxiety levels will be assessed at baseline and at the end of the monitoring period using the State Anxiety Inventory (STAI-I).

This study aims to determine whether VR and classical music can enhance routine management by improving early percentage change in mean arterial pressure and decreasing anxiety levels during acute hypertensive episodes. Findings may support the incorporation of non-pharmacological strategies into the emergency management of hypertensive urgency.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Çankaya
      • Ankara, Çankaya, Turkey (Türkiye), 06170
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or older
  • Clinical diagnosis of primary hypertension
  • Presentation to the emergency department with hypertensive urgency
  • Absence of any signs of acute end-organ damage
  • Ability to understand the study and provide informed consent
  • Able to cooperate with serial blood pressure measurements

Exclusion Criteria:

  • Age younger than 18 years
  • Diagnosis of secondary hypertension
  • Any medication intolerance or known hypersensitivity to captopril or nitrate therapy
  • Current severe psychiatric disorder or cognitive impairment interfering with participation
  • Contraindications to using virtual reality (history of severe vertigo, epilepsy, motion sickness, etc.)
  • Hemodynamic instability requiring immediate high-intensity medical intervention
  • Pregnancy or breastfeeding
  • Inability or unwillingness to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Pharmacological Treatment
Participants in this arm will receive standard oral antihypertensive treatment consisting of 25 mg captopril. Additional doses (25 mg at 30 minutes and 25 mg at 60 minutes, total 75 mg) will be administered if systolic blood pressure remains ≥180 mmHg or diastolic blood pressure remains ≥110 mmHg during follow-up. Rescue therapy with IV nitrate (0.1 mg/kg/min) will be used if blood pressure remains uncontrolled after 90 minutes, following routine emergency department protocol. No VR or music therapy is administered in this arm.
This drug is administered to participants in both study arms. Standard oral antihypertensive treatment with 25 mg captopril is given at baseline, with additional doses administered during follow-up as needed according to the study protocol. Rescue therapy with IV nitrate (0.1 mg/kg/min) may be used if blood pressure remains uncontrolled after 90 minutes.
Experimental: Standard Treatment + VR and Classical Music Therapy
Participants in this arm will receive standard oral antihypertensive treatment consisting of 25 mg captopril. Additional doses (25 mg at 30 minutes and 25 mg at 60 minutes, total 75 mg) will be administered if systolic blood pressure remains ≥180 mmHg or diastolic blood pressure remains ≥110 mmHg during follow-up. In addition to standard treatment, participants will receive virtual reality exposure combined with classical music therapy. Patients will view a calming VR environment while listening to a selected piece of classical music. VR and music therapy are administered concurrently in a quiet and dimly lit room. Rescue therapy with IV nitrate (0.1 mg/kg/min) will be used if blood pressure remains uncontrolled after 90 minutes, following the same emergency department protocol as the control group.
This intervention is administered only to participants in the 'Standard Treatment + VR and Classical Music Therapy' arm. Participants listen to one of several selected classical music pieces at a comfortable volume (40-60 dB) during the VR exposure. Music therapy is applied simultaneously with standard antihypertensive treatment to support relaxation.
This intervention is administered only to participants in the 'Standard Treatment + VR and Classical Music Therapy' arm. Participants view a calming virtual environment of their choice using a non-proprietary VR headset.The session is delivered concurrently with standard antihypertensive treatment in a quiet, dimly lit room
This drug is administered to participants in both study arms. Standard oral antihypertensive treatment with 25 mg captopril is given at baseline, with additional doses administered during follow-up as needed according to the study protocol. Rescue therapy with IV nitrate (0.1 mg/kg/min) may be used if blood pressure remains uncontrolled after 90 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean Arterial Pressure (MAP) at 30 Minutes
Time Frame: Baseline (after 10 minutes of rest) and 30 minutes after treatment initiation
Mean arterial pressure will be measured at baseline (after 10 minutes of rest) and again at 30 minutes after the initial treatment. The primary endpoint is the percentage change in MAP at 30 minutes compared with baseline. Positive values indicate a reduction in MAP.
Baseline (after 10 minutes of rest) and 30 minutes after treatment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in State Anxiety Level (State Anxiety Inventory - Form I)
Time Frame: Baseline and 120 minutes
State anxiety will be measured using the State Anxiety Inventory - Form I (STAI-I), a validated 20-item scale assessing situational anxiety. Total scores range from 20 to 80, with higher scores indicating higher levels of state anxiety. STAI-I will be administered at baseline and at 120 minutes to evaluate changes during the observation period.
Baseline and 120 minutes
Incidence of Adverse Events
Time Frame: Up to 120 minutes
Frequency and type of adverse events related to antihypertensive medication or VR/music therapy (e.g., dizziness, nausea, hypotension) will be documented during the entire observation period.
Up to 120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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