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

University of Baghdad140 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

140

Conditions

Sleep Disturbances

Interventions

Virtual Reality RelaxationBEHAVIORAL

Guided VR relaxation sessions to reduce discomfort an enhance sleep quality

Binaural Beat StimulationBEHAVIORAL

Guide sessions BBS to reduce discomfort and enhance sleep quality

VR + Binaural Beat GroupBEHAVIORAL

Combined VR \& BBS sessions

Standard Postoperative careOTHER

Usual postoperative care for patients

Eligibility

Sex: ALLMin age: 28 YearsMax age: 71 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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