Sleep DisturbancesVR-BBSNCT07365488
Effect of Virtual Reality and Binaural Beat on Sleep and Comfort in Adults After Mechanical Valve Replacement Surgery
A study testing Virtual Reality Relaxation, Binaural Beat Stimulation and VR + Binaural Beat Group in people with Sleep Disturbances and Postoperative Discomfort, run by University of Baghdad at 1 site in Iraq.
Trial summary
This study will compare the effects of Virtual Reality and Binaural Beat Stimulation on sleep quality and discomfort in adult patients who have undergone prosthetic mechanical valve replacement surgery. Many patients experience sleep disturbances and discomfort due to the sound of the mechanical valve. Read more about this study
- Who is it for?
- Ages 28 to 71 years
- Conditions the study is for
- Sleep Disturbances, Postoperative Discomfort, Heart Valve Diseases
- What is being tested?
- Virtual Reality Relaxation, Binaural Beat Stimulation and VR + Binaural Beat Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIraq
- Study dates
- 1 Nov 2025to 10 Jan 2026
- 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 28 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be eligible for participation following mechanical valve replacement surgery if they are willing to participate, able to provide informed consent, and meet the following criteria: male or female aged 18 years or older, hemodynamically stable, oriented and conscious without cognitive impairment, free from visual or auditory impairments, able to communicate orally in Arabic, not receiving analgesics or sedatives within at least four hours prior to the intervention, and having no history of epilepsy, seizure disorders, or recurrent migraines.
Who cannot join
- The study's exclusion criteria will include participants with facial or head injuries, a history of vertigo or severe motion sickness, immediate postoperative cardiac arrest, the use of hypnotic medications, the presence of a tracheostomy, or any implanted body hardware.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Virtual Reality Versus Binaural Beat Stimulation on Sleep Disturbances and Patient Discomfort Following Prosthetic Mechanical Valve Replacement Surgery: A Randomized Controlled Trial
This study will compare the effects of Virtual Reality and Binaural Beat Stimulation on sleep quality and discomfort in adult patients who have undergone prosthetic mechanical valve replacement surgery. Many patients experience sleep disturbances and discomfort due to the sound of the mechanical valve. Participants will be randomly assigned to one of two non-drug interventions to see which method improves sleep and reduces discomfort after surgery. The study aims to help improve recovery and comfort for patients after valve replacement.
Read the detailed description
This randomized clinical trial will evaluate the effects of four interventions on sleep disturbances and patient discomfort in adult patients after prosthetic mechanical valve replacement. Sleep disturbances are common due to the sound of the mechanical valve. Participants will be randomly assigned to one of four groups: (1) VR Group (2) Binaural Beat Group listening to binaural beats for 20 minutes (3) VR + Binaural Beat Group combining both interventions, and (4) Control Group receiving standard postoperative care without interventions. Primary outcomes include sleep quality and patient-reported discomfort measured during the early postoperative period. The study aims to identify which intervention or combination is most effective in improving recovery and patient comfort.
- Being tested
- Virtual Reality Relaxation, Binaural Beat Stimulation, VR + Binaural Beat Group, Standard Postoperative care
- Keywords
- Virtual Reality, Binaural Beat Stimulation, Cardiac Surgery, Mechanical Heart Valve, Sleep Quality, Patient Discomfort
- Medical subject headings
- Parasomnias, Heart Valve Diseases, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality RelaxationBehavioural
Guided VR relaxation sessions to reduce discomfort an enhance sleep quality
Binaural Beat StimulationBehavioural
Guide sessions BBS to reduce discomfort and enhance sleep quality
VR + Binaural Beat GroupBehavioural
Combined VR \& BBS sessions
Standard Postoperative careOther
Usual postoperative care for patients
| Study group | Role | What they receive |
|---|---|---|
| VR Group | Experimental | Guided VR relaxation sessions Receives: Behavioral: Virtual Reality Relaxation; Behavioral: VR + Binaural Beat Group |
| Binaural Beat Group | Experimental | sessions BBS for reducing discomfort and enhance sleep quality Receives: Behavioral: Binaural Beat Stimulation; Behavioral: VR + Binaural Beat Group |
| VR + Binaural Beat Group | Experimental | Combined VR \& BBS sessions Receives: Behavioral: VR + Binaural Beat Group |
| Control Group | Other | Standard postoperative care Receives: Other: Standard Postoperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Discomfort
Patient-reported discomfort measured using the Kolcaba Verbal Rating Comfort Scale (KCS), assessing the intensity of postoperative discomfort following prosthetic mechanical valve replacement. This measure captures the level of discomfort experienced by the patient during hospitalization that result from mechanical valve sound.
Measured: From postoperative day 3 until discharge from the cardiac surgery ward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Nov 2025
- Primary completion10 Jan 2026
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbancesStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. VR Group - receiving a Virtual Reality relaxation sessiones. 2. Binaural Beat Group - receiving a Binaural Beat Stimulation sessions. 3. VR + Binaural Beat Group - receiving both interventions. 4. Control Group - receiving standard postoperative care without interventionsز Randomization ensures that each participant has an equal chance of being assigned to any group, and all groups are followed concurrently to compare outcome.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Abdul-Rasool Abbas, University of Baghdad
- Investigators
- Waffa AR Hattab, Ph.D., Principal investigator, University of Baghdad, College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365488
- Sponsor's protocol ID
- VRBBS-MVR-SOUND-OF-THE- VALVE
- Other IDs
- 24-18-Nov-2025
- Acronym
- VR-BBS
- Status last verified
- Feb 2026
- First submitted
- 16 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Versus Binaural Beat Stimulation on Sleep Disturbances and Patient Discomfort Following Prosthetic Mechanical Valve Replacement Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07365488
- Acronym / sponsor ID
- VR-BBS / VRBBS-MVR-SOUND-OF-THE- VALVE
- Keywords
- Virtual Reality, Binaural Beat Stimulation, Cardiac Surgery, Mechanical Heart Valve, Sleep Quality, Patient Discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 26 Jan 2026 (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 will compare the effects of Virtual Reality and Binaural Beat Stimulation on sleep quality and discomfort in adult patients who have undergone prosthetic mechanical valve replacement surgery. Many patients experience sleep disturbances and discomfort due to the sound of the mechanical valve. Participants will be randomly assigned to one of two non-drug interventions to see which method improves sleep and reduces discomfort after surgery. The study aims to help improve recovery and comfort for patients after valve replacement.
Detailed description
This randomized clinical trial will evaluate the effects of four interventions on sleep disturbances and patient discomfort in adult patients after prosthetic mechanical valve replacement. Sleep disturbances are common due to the sound of the mechanical valve. Participants will be randomly assigned to one of four groups: (1) VR Group (2) Binaural Beat Group listening to binaural beats for 20 minutes (3) VR + Binaural Beat Group combining both interventions, and (4) Control Group receiving standard postoperative care without interventions. Primary outcomes include sleep quality and patient-reported discomfort measured during the early postoperative period. The study aims to identify which intervention or combination is most effective in improving recovery and patient comfort.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 1. VR Group - receiving a Virtual Reality relaxation sessiones. 2. Binaural Beat Group - receiving a Binaural Beat Stimulation sessions. 3. VR + Binaural Beat Group - receiving both interventions. 4. Control Group - receiving standard postoperative care without interventionsز Randomization ensures that each participant has an equal chance of being assigned to any group, and all groups are followed concurrently to compare outcome.
| Arm | Type | Receives |
|---|---|---|
| VR Group | Experimental | Behavioral: Virtual Reality Relaxation, Behavioral: VR + Binaural Beat GroupGuided VR relaxation sessions |
| Binaural Beat Group | Experimental | Behavioral: Binaural Beat Stimulation, Behavioral: VR + Binaural Beat Groupsessions BBS for reducing discomfort and enhance sleep quality |
| VR + Binaural Beat Group | Experimental | Behavioral: VR + Binaural Beat GroupCombined VR \& BBS sessions |
| Control Group | Other | Other: Standard Postoperative careStandard postoperative care |
Who may qualify
- Ages
- 28 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will be eligible for participation following mechanical valve replacement surgery if they are willing to participate, able to provide informed consent, and meet the following criteria: male or female aged 18 years or older, hemodynamically stable, oriented and conscious without cognitive impairment, free from visual or auditory impairments, able to communicate orally in Arabic, not receiving analgesics or sedatives within at least four hours prior to the intervention, and having no history of epilepsy, seizure disorders, or recurrent migraines.
Key exclusion criteria (1 listed)
- The study's exclusion criteria will include participants with facial or head injuries, a history of vertigo or severe motion sickness, immediate postoperative cardiac arrest, the use of hypnotic medications, the presence of a tracheostomy, or any implanted body hardware.
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 |
|---|---|---|
| Virtual Reality RelaxationGuided VR relaxation sessions to reduce discomfort an enhance sleep quality | Behavioural | VR Group |
| Binaural Beat StimulationGuide sessions BBS to reduce discomfort and enhance sleep quality | Behavioural | Binaural Beat Group |
| VR + Binaural Beat GroupCombined VR \& BBS sessions | Behavioural | Binaural Beat Group, VR + Binaural Beat Group, VR Group |
| Standard Postoperative careUsual postoperative care for patients | Other | Control Group |
Primary outcome
Patient Discomfort
Time frame: From postoperative day 3 until discharge from the cardiac surgery ward
Patient-reported discomfort measured using the Kolcaba Verbal Rating Comfort Scale (KCS), assessing the intensity of postoperative discomfort following prosthetic mechanical valve replacement. This measure captures the level of discomfort experienced by the patient during hospitalization that result from mechanical valve sound.
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 18 Feb 2026.
- University of Baghdad, College of NursingLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Waffa AR Hattab, Ph.D. principal investigator
University of Baghdad, College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Relaxation, Binaural Beat Stimulation and VR + Binaural Beat Group in people with Sleep Disturbances and Postoperative Discomfort, run by University of Baghdad at 1 site in Iraq.
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 1 inclusion and 1 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 18 Feb 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 Iraq. 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?
Patient Discomfort (time frame: From postoperative day 3 until discharge from the cardiac surgery ward). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2026.