NCT07365488

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

Effect of Virtual Reality Versus Binaural Beat Stimulation on Sleep Disturbances and Patient Discomfort Following Prosthetic Mechanical Valve Replacement Surgery: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: University of Baghdad · Academic / Other
• Sex: All
• Age: 28 Years – 71 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Sleep Disturbances
• Postoperative Discomfort
• Heart Valve Diseases

Interventions

Type	Name	Description
BEHAVIORAL	Virtual Reality Relaxation	Guided VR relaxation sessions to reduce discomfort an enhance sleep quality
BEHAVIORAL	Binaural Beat Stimulation	Guide sessions BBS to reduce discomfort and enhance sleep quality
BEHAVIORAL	VR + Binaural Beat Group	Combined VR \& BBS sessions
OTHER	Standard Postoperative care	Usual postoperative care for patients

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-01-10
• Completion: 2026-01-10
• First posted: 2026-01-26
• Last updated: 2026-02-18

Locations

1 site across 1 country: Iraq