- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07272486
The Use of Virtual Reality and Music Therapy for Hypertensive Urgency
Effect of Virtual Reality and Classical Music Therapy on Blood Pressure and Anxiety in Patients With Hypertensive Urgency
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Çankaya
-
Ankara, Çankaya, Turkey (Türkiye), 06170
- Ankara Bilkent City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2-24-7802 (Other Identifier: Ankara Bilkent City Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Hypertensive Urgency
-
Russian Cardiology Research and Production CenterKRKACompleted
-
Saglik Bilimleri UniversitesiEtimesgut Military HospitalRecruiting
-
RWTH Aachen UniversityCompletedHypertensive Urgency | Hypertensive EmergencyGermany
-
The Cleveland ClinicEKR Therapeutics, IncCompletedHypertensive UrgencyUnited States
-
Khon Kaen UniversityCompleted
-
Centre Hospitalier Departemental VendeeRecruiting
-
Neuspera Medical, Inc.Active, not recruitingUrinary Urgency IncontinenceUnited States, Netherlands, Belgium
-
Oregon Health and Science UniversityCompleted
-
Albany Medical CollegeNot yet recruiting
-
Neuspera Medical, Inc.RecruitingUrinary Urgency IncontinenceUnited States
Clinical Trials on Classic Music Therapy
-
KTO Karatay UniversityCompleted
-
Selcuk UniversityCompletedMusic | Preterm | Vital Signs | Nutrition Disorder, InfantTurkey
-
Universidad de AlmeriaCompletedLow Back Pain | Musculoskeletal ManipulationsSpain
-
Case Comprehensive Cancer CenterCompletedMultiple Myeloma | Hodgkin Lymphoma | Non-Hodgkin LymphomaUnited States
-
University of North Carolina, Chapel HillNorth Carolina Translational and Clinical Sciences InstituteCompletedAutonomic Nervous System Imbalance | Hypothalamic Pituitary Adrenal Axis SuppressionUnited States
-
University of PennsylvaniaConestoga High SchoolCompletedStress | Cognitive Impairment | DementiaUnited States
-
Wayne State UniversityCompletedNeurological DisordersUnited States
-
Icahn School of Medicine at Mount SinaiCompletedSARS-CoV 2 | Dyspnea | Post Covid-19 RespiratoryUnited States
-
Icahn School of Medicine at Mount SinaiCompleted