MedDataX Logo

The Use of Virtual Reality and Music Therapy for Hypertensive Urgency

NCT ID: NCT07272486

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 240-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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 240 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 blood pressure reduction and decreasing anxiety levels during acute hypertensive episodes. Findings may support the incorporation of non-pharmacological strategies into the emergency management of hypertensive urgency.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertensive Urgency Primary Hypertension

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 240 minutes with repeated blood pressure and anxiety assessments
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 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.

Group Type ACTIVE_COMPARATOR

Captopril 25Mg Tab

Intervention Type 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 Treatment + VR and Classical Music Therapy

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 for approximately 20 minutes while listening to a selected classical music piece. 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.

Group Type EXPERIMENTAL

Captopril 25Mg Tab

Intervention Type 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

Virtual Reality Exposure

Intervention Type 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 for approximately 20 minutes using a non-proprietary VR headset. The session is delivered concurrently with standard antihypertensive treatment in a quiet, dimly lit room

Classic Music Therapy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Captopril 25Mg Tab

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

Intervention Type DRUG

Virtual Reality Exposure

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 for approximately 20 minutes using a non-proprietary VR headset. The session is delivered concurrently with standard antihypertensive treatment in a quiet, dimly lit room

Intervention Type DEVICE

Classic Music Therapy

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Safa Dönmez

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ankara Bilkent City Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 37644380 (View on PubMed)

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.

Reference Type RESULT
PMID: 38132649 (View on PubMed)

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.

Reference Type RESULT
PMID: 27294333 (View on PubMed)

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.

Reference Type RESULT
PMID: 36418425 (View on PubMed)

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.

Reference Type RESULT
PMID: 34825613 (View on PubMed)

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.

Reference Type RESULT
PMID: 32371787 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E2-24-7802

Identifier Type: OTHER

Identifier Source: secondary_id

E2-24-7802

Identifier Type: -

Identifier Source: org_study_id