Postoperative Sleep Quality Following Total Joint Arthroplasty: A Prospective, Randomized, Controlled Trial of Diphenhydramine and Melatonin Versus Sleep Skills Training
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
To compare non-prescription sleep aids (low-dose diphenhydramine and melatonin) to sleep hygiene education for improving postoperative sleep quality after total joint arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
- Benadryl + Melatonin Group + Sleep Hygiene Education
- Sleep Hygiene Education Group
- Control group (Usual Care)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing elective primary total hip or knee arthroplasty
排除标准
- •History of substance abuse
- •Workman's compensation patients
- •Revision joint replacement
- •History of prescription or over-the- counter sleep aid use
研究组 & 干预措施
Sleep Hygiene Education
Sleep Hygiene Education: Participants are provided a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
干预措施: Sleep Hygiene Education (Behavioral)
Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin)
Participants are given both:
- Over-the-counter sleep aids:25 mg Diphenhydramine (Benadryl) and 3mg oral melatonin to be taken before bedtime;
- and a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
干预措施: Diphenhydramine (Benadryl) (Drug)
Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin)
Participants are given both:
- Over-the-counter sleep aids:25 mg Diphenhydramine (Benadryl) and 3mg oral melatonin to be taken before bedtime;
- and a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
干预措施: Melatonin (Dietary Supplement)
Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin)
Participants are given both:
- Over-the-counter sleep aids:25 mg Diphenhydramine (Benadryl) and 3mg oral melatonin to be taken before bedtime;
- and a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
干预措施: Sleep Hygiene Education (Behavioral)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline, 2 weeks, 6 weeks and 12 weeks post-op
The PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the nine component scores, providing an overall score ranging from 0 to 27, where lower scores denote a healthier sleep quality.
Epworth Sleepiness Scale (ESS)
时间窗: Baseline, 2 weeks, 6 weeks and 12 weeks post-op
Epworth Sleepiness Scale is widely used in the field of sleep medicine as a subjective measure of a patient's sleepiness. The test is a list of eight situations in which to rate the participants tendency to become sleepy. * No chance of dozing = 0 * Slight chance of dozing = 1 * Moderate chance of dozing = 2 * High chance of dozing = 3 Total the values of the responses. The total score is based on a scale of 0 to 24. The higher score the higher the chance the participant is experiencing excessive sleepiness.
Visual Analogue Scale (VAS) for Pain
时间窗: Baseline, 2 weeks, 6 weeks and 12 weeks post-op
Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain
次要结局
未报告次要终点
研究者
James A. Keeney
Chief Adult Hip and Knee Reconstruction Service, Department of Orthopaedic Surgery, University of Missouri
University of Missouri-Columbia