To compare non-prescription sleep aids (low-dose diphenhydramine and melatonin) to sleep hygiene education for improving postoperative sleep quality after total joint arthroplasty.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
55
Oral Diphenhydramine (Benadryl), 25 mg
Oral Melatonin, 3 mg
Brochure containing information about getting a "good night's sleep."
Vicki L Jones
Columbia, Missouri, United States
Epworth Sleepiness Scale (ESS)
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.
Time frame: Baseline, 2 weeks, 6 weeks and 12 weeks post-op
Pittsburgh Sleep Quality Index (PSQI)
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
Visual Analogue Scale (VAS) for Pain
Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain
Time frame: Baseline, 2 weeks, 6 weeks and 12 weeks post-op
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