The Use of Virtual Reality and Music Therapy for Hypertensive Urgency

NCT07272486 | Completed

• 1 other identifier: E2-24-7802
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertensive Urgency; Primary Hypertension

Keywords

Hypertensive Urgency; Primary Hypertension; Virtual Reality Therapy; Classical Music Therapy; Stress Reduction; Blood Pressure Control; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Change in Mean Arterial Pressure (MAP) at 30 Minutes

  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 reduction in MAP at 30 minutes compared with baseline, with a target reduction of at least 25%.

  Baseline (after 10 minutes of rest) and 30 minutes after treatment initiation

Secondary Outcomes (2)

• Change in State Anxiety Level (State Anxiety Inventory - Form I)

  Baseline and 120 minutes

• Incidence of Adverse Events

  Up to 120 minutes

Study Arms (2)

Standard Pharmacological Treatment

ACTIVE COMPARATOR

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 MAP reduction of ≥25% is not achieved. 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.

Drug: Captopril 25Mg Tab

Standard Treatment + VR and Classical Music Therapy

EXPERIMENTAL

Participants in this arm will receive standard oral antihypertensive treatment (25 mg captopril; additional doses at 30 and 60 minutes if needed) combined with virtual reality exposure and classical music therapy. Patients will view a calming VR environment of their choice 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 will be used according to the same emergency department protocol as the control group.

Drug: Captopril 25Mg Tab; Device: Virtual Reality Exposure; Behavioral: Classic Music Therapy

Interventions

Virtual Reality Exposure DEVICE

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

Standard Treatment + VR and Classical Music Therapy

Classic Music Therapy BEHAVIORAL

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.

Standard Treatment + VR and Classical Music Therapy

Captopril 25Mg Tab DRUG

This drug is administered to participants in both study arms. Standard oral antihypertensive treatment with 25 mg captopril is given at baseline. Additional 25 mg doses may be administered at 30 and 60 minutes if ≥25% MAP reduction is not achieved. Rescue therapy with IV nitrate may be used after 90 minutes according to routine emergency department protocol

Standard Pharmacological Treatment; Standard Treatment + VR and Classical Music Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06170, Turkey (Türkiye)

Location

Related Publications (6)

• Vorwerg-Gall S, Stamm O, Haink M. Virtual reality exergame in older patients with hypertension: a preliminary study to determine load intensity and blood pressure. BMC Geriatr. 2023 Aug 30;23(1):527. doi: 10.1186/s12877-023-04245-x.

  PMID: 37644380 RESULT

• Jiravska Godula B, Jiravsky O, Matheislova G, Kuriskova V, Valkova A, Puskasova K, Dokoupil M, Dvorakova V, Prifti A, Foral D, Jiravsky F, Hecko J, Hudec M, Neuwirth R, Miklik R. Virtual Reality for Patient Education about Hypertension: A Randomized Pilot Study. J Cardiovasc Dev Dis. 2023 Nov 29;10(12):481. doi: 10.3390/jcdd10120481.

  PMID: 38132649 RESULT

• Patel KK, Young L, Howell EH, Hu B, Rutecki G, Thomas G, Rothberg MB. Characteristics and Outcomes of Patients Presenting With Hypertensive Urgency in the Office Setting. JAMA Intern Med. 2016 Jul 1;176(7):981-8. doi: 10.1001/jamainternmed.2016.1509.

  PMID: 27294333 RESULT

• Kulkarni S, Glover M, Kapil V, Abrams SML, Partridge S, McCormack T, Sever P, Delles C, Wilkinson IB. Management of hypertensive crisis: British and Irish Hypertension Society Position document. J Hum Hypertens. 2023 Oct;37(10):863-879. doi: 10.1038/s41371-022-00776-9. Epub 2022 Nov 22.

  PMID: 36418425 RESULT

• Qin Z, Zhou C, Zhu Y, Wang Y, Cao H, Li W, Huang Z. Virtual Reality for Hypertension in Tooth Extraction: A Randomized Trial. J Dent Res. 2022 Apr;101(4):400-406. doi: 10.1177/00220345211049393. Epub 2021 Nov 26.

  PMID: 34825613 RESULT

• Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, Ramirez A, Schlaich M, Stergiou GS, Tomaszewski M, Wainford RD, Williams B, Schutte AE. 2020 International Society of Hypertension global hypertension practice guidelines. J Hypertens. 2020 Jun;38(6):982-1004. doi: 10.1097/HJH.0000000000002453. No abstract available.

  PMID: 32371787 RESULT

MeSH Terms

Conditions

Hypertensive Crisis; Essential Hypertension; Emergencies

Interventions

Captopril

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study uses a two-arm parallel assignment model in which participants are randomized in a 1:1 ratio to receive either standard pharmacological treatment alone or standard treatment combined with virtual reality and classical music therapy. All interventions are delivered concurrently with routine management in a controlled emergency department environment, and participants are followed for 120 minutes with repeated blood pressure and anxiety assessments

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: August 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: April 15, 2026

Record last verified: 2025-12

Locations

TU (1)