Hypertensive UrgencyNCT07272486
The Use of Virtual Reality and Music Therapy for Hypertensive Urgency
A study testing Captopril 25Mg Tab, Virtual Reality Exposure and Classic Music Therapy in people with Hypertensive Urgency and Primary Hypertension, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertensive Urgency, Primary Hypertension
- What is being tested?
- Captopril 25Mg Tab, Virtual Reality Exposure and Classic Music Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06170
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertensive Urgency, Primary Hypertension
- Being tested
- Captopril 25Mg Tab, Virtual Reality Exposure, Classic Music Therapy
- Keywords
- Hypertensive Urgency, Primary Hypertension, Virtual Reality Therapy, Classical Music Therapy, Stress Reduction, Blood Pressure Control, Emergency Department
- Medical subject headings
- Hypertensive Crisis, Essential Hypertension, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Captopril 25Mg TabDrug
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.
Virtual Reality ExposureDevice
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
Classic Music TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 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. Receives: Drug: Captopril 25Mg Tab |
| Standard Treatment + VR and Classical Music Therapy | Experimental | 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. Receives: Drug: Captopril 25Mg Tab; Device: Virtual Reality Exposure; Behavioral: Classic Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 change in MAP at 30 minutes compared with baseline. Positive values indicate a reduction in MAP.
Measured: 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)
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.
Measured: Baseline and 120 minutes
Incidence of Adverse Events
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.
Measured: Up to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Aug 2024
- Primary completion31 Jul 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hypertensive UrgencyStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safa Dönmez, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272486
- Sponsor's protocol ID
- E2-24-7802
- Other IDs
- E2-24-7802
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 37644380Jiravska 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.
PubMed 38132649Patel 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.
PubMed 27294333Kulkarni 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.
PubMed 36418425Qin 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.
PubMed 34825613Unger 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.
PubMed 32371787
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality and Classical Music Therapy on Blood Pressure and Anxiety in Patients With Hypertensive Urgency
- ClinicalTrials.gov ID
- NCT07272486
- Acronym / sponsor ID
- E2-24-7802
- Conditions
- Hypertensive Urgency, Primary Hypertension
- Keywords
- Hypertensive Urgency, Primary Hypertension, Virtual Reality Therapy, Classical Music Therapy, Stress Reduction, Blood Pressure Control, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Standard Pharmacological Treatment | Active comparator | Drug: Captopril 25Mg TabParticipants 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. |
| Standard Treatment + VR and Classical Music Therapy | Experimental | Drug: Captopril 25Mg Tab, Device: Virtual Reality Exposure, Behavioral: Classic Music TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Captopril 25Mg TabThis 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. | Drug | Standard Pharmacological Treatment, Standard Treatment + VR and Classical Music Therapy |
| Virtual Reality ExposureThis 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 | Device | Standard Treatment + VR and Classical Music Therapy |
| Classic Music TherapyThis 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. | Behavioural | Standard Treatment + VR and Classical Music Therapy |
Primary outcome
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.
2 secondary outcomes
Change in State Anxiety Level (State Anxiety Inventory - Form I)
Time frame: Baseline and 120 minutes
Incidence of Adverse Events
Time frame: Up to 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Results publication: PubMed 37644380Vorwerg-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.
- Results publication: PubMed 38132649Jiravska 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.
- Results publication: PubMed 27294333Patel 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.
- Results publication: PubMed 36418425Kulkarni 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.
- Results publication: PubMed 34825613Qin 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.
- Results publication: PubMed 32371787Unger 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Captopril 25Mg Tab, Virtual Reality Exposure and Classic Music Therapy in people with Hypertensive Urgency and Primary Hypertension, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Arterial Pressure (MAP) at 30 Minutes (time frame: Baseline (after 10 minutes of rest) and 30 minutes after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07272486, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.