Vicki L Jones
Columbia, Missouri, 65212, United States
NCT Number: NCT03968939
To compare non-prescription sleep aids (low-dose diphenhydramine and melatonin) to sleep hygiene education for improving postoperative sleep quality after total joint arthroplasty.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Columbia, Missouri, 65212, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All patients undergoing elective primary total hip or knee arthroplasty
Exclusion criteria
Oral Diphenhydramine (Benadryl), 25 mg
Oral Melatonin, 3 mg
Brochure containing information about getting a "good night's sleep."
Time frame: 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.
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.
Time frame: 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.
Time frame: 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
James A. Keeney
Other
Postoperative Sleep Quality Following Total Joint Arthroplasty: A Prospective, Randomized, Controlled Trial of Diphenhydramine and Melatonin Versus Sleep Skills Training
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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