Total Joint Arthroplasty and Sleep
- Conditions
- Primary Total Hip ArthroplastyPrimary Total Knee Arthroplasty
- Interventions
- Registration Number
- NCT03968939
- Lead Sponsor
- James A. Keeney
- Brief Summary
To compare non-prescription sleep aids (low-dose diphenhydramine and melatonin) to sleep hygiene education for improving postoperative sleep quality after total joint arthroplasty.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
All patients undergoing elective primary total hip or knee arthroplasty
- History of substance abuse
- Workman's compensation patients
- Revision joint replacement
- History of prescription or over-the- counter sleep aid use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin) Diphenhydramine (Benadryl) Participants are given both: 1. Over-the-counter sleep aids:25 mg Diphenhydramine (Benadryl) and 3mg oral melatonin to be taken before bedtime; 2. and a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep." Sleep Hygiene Education Sleep Hygiene Education Sleep Hygiene Education: Participants are provided a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep." Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin) Melatonin Participants are given both: 1. Over-the-counter sleep aids:25 mg Diphenhydramine (Benadryl) and 3mg oral melatonin to be taken before bedtime; 2. and a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep." Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin) Sleep Hygiene Education Participants are given both: 1. Over-the-counter sleep aids:25 mg Diphenhydramine (Benadryl) and 3mg oral melatonin to be taken before bedtime; 2. and a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
- Primary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index (PSQI) 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) 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vicki L Jones
🇺🇸Columbia, Missouri, United States