Effect of Virtual Reality Versus Binaural Beat Stimulation on Sleep Disturbances and Patient Discomfort Following Prosthetic Mechanical Valve Replacement Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Patient Discomfort
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Not applicable - study is open label; all participants and staff are aware of the interventions.
入排标准
- 年龄范围
- 28 Years 至 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
VR + Binaural Beat Group
Combined VR & BBS sessions
干预措施: VR + Binaural Beat Group (Behavioral)
VR Group
Guided VR relaxation sessions
干预措施: Virtual Reality Relaxation (Behavioral)
VR Group
Guided VR relaxation sessions
干预措施: VR + Binaural Beat Group (Behavioral)
Control Group
Standard postoperative care
干预措施: Standard Postoperative care (Other)
Binaural Beat Group
sessions BBS for reducing discomfort and enhance sleep quality
干预措施: Binaural Beat Stimulation (Behavioral)
Binaural Beat Group
sessions BBS for reducing discomfort and enhance sleep quality
干预措施: VR + Binaural Beat Group (Behavioral)
结局指标
主要结局
Patient Discomfort
时间窗: 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.
次要结局
未报告次要终点
研究者
Ali Abdul-Rasool Abbas
MSc Nursing, University of Baghdad, Adult Nursing
University of Baghdad