CompletedNot Applicable

Effect of Virtual Reality and Binaural Beat on Sleep and Comfort in Adults After Mechanical Valve Replacement Surgery

Iraq140 participantsStarted 2025-11-01

Plain-language 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. 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.

Who can participate

Age range

28 Years – 71 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient Discomfort

Timeframe: From postoperative day 3 until discharge from the cardiac surgery ward

Trial details

NCT IDNCT07365488

SponsorUniversity of Baghdad

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-10

View on ClinicalTrials.gov More Sleep Disturbances trials