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

NCT07365488 | Completed

• 2 other identifiers: VRBBS-MVR-SOUND-OF-THE- VALVE24-18-Nov-2025
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Discomfort; Heart Valve Diseases; Sleep Disturbances

Keywords

Virtual Reality; Binaural Beat Stimulation; Cardiac Surgery; Mechanical Heart Valve; Sleep Quality; Patient Discomfort

Outcome Measures

Primary Outcomes (1)

• 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.

  From postoperative day 3 until discharge from the cardiac surgery ward

Study Arms (4)

VR Group

EXPERIMENTAL

Guided VR relaxation sessions

Behavioral: Virtual Reality Relaxation; Behavioral: VR + Binaural Beat Group

Binaural Beat Group

EXPERIMENTAL

sessions BBS for reducing discomfort and enhance sleep quality

Behavioral: Binaural Beat Stimulation; Behavioral: VR + Binaural Beat Group

VR + Binaural Beat Group

EXPERIMENTAL

Combined VR \& BBS sessions

Behavioral: VR + Binaural Beat Group

Control Group

OTHER

Standard postoperative care

Other: Standard Postoperative care

Interventions

Virtual Reality Relaxation BEHAVIORAL

Guided VR relaxation sessions to reduce discomfort an enhance sleep quality

VR Group

Binaural Beat Stimulation BEHAVIORAL

Guide sessions BBS to reduce discomfort and enhance sleep quality

Binaural Beat Group

VR + Binaural Beat Group BEHAVIORAL

Combined VR \& BBS sessions

Binaural Beat Group; VR + Binaural Beat Group; VR Group

Standard Postoperative care OTHER

Usual postoperative care for patients

Control Group

Eligibility Criteria

• Age: 28 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Ibn Al-Nafees Teaching Hospital

Baghdad, Baghdad Governorate, Iraq

Location

Related Links

• University of Baghdad, College of Nursing

MeSH Terms

Conditions

Parasomnias; Heart Valve Diseases; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Heart Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Waffa AR Hattab, Ph.D.

  University of Baghdad, College of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable - study is open label; all participants and staff are aware of the interventions.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Nursing, University of Baghdad, Adult Nursing

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 26, 2026
• Study Start: November 1, 2025
• Primary Completion: January 10, 2026
• Study Completion: January 10, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)