Ibn Al-Nafees Teaching Hospital
Baghdad, Baghdad Governorate, Iraq
NCT Number: NCT07365488
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.
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Notify Me28 year–71 year
All sexes
Interventional
Not applicable
Baghdad, Baghdad Governorate, Iraq
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Guided VR relaxation sessions to reduce discomfort an enhance sleep quality
Guide sessions BBS to reduce discomfort and enhance sleep quality
Combined VR & BBS sessions
Usual postoperative care for patients
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.
University of Baghdad
Other
Effect of Virtual Reality Versus Binaural Beat Stimulation on Sleep Disturbances and Patient Discomfort Following Prosthetic Mechanical Valve Replacement Surgery: A Randomized Controlled Trial
Acronym: VR-BBS
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