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OpenTrials
Completed

NCT Number: NCT03968939

Total Joint Arthroplasty and Sleep

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vicki L Jones

Columbia, Missouri, 65212, United States

Who can participate

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

  • History of substance abuse
  • Workman's compensation patients
  • Revision joint replacement
  • History of prescription or over-the- counter sleep aid use

Treatment and study plan

Diphenhydramine (Benadryl)

Drug

Oral Diphenhydramine (Benadryl), 25 mg

melatonin

Dietary Supplement

Oral Melatonin, 3 mg

Sleep Hygiene Education

Behavioral

Brochure containing information about getting a "good night's sleep."

Primary outcomes

  1. Epworth Sleepiness Scale (ESS)

    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.

    • 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.

  2. Pittsburgh Sleep Quality Index (PSQI)

    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.

  3. Visual Analogue Scale (VAS) for Pain

    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

Sponsors and collaborators

Lead sponsor

James A. Keeney

Other

Registry information

Official study title

Postoperative Sleep Quality Following Total Joint Arthroplasty: A Prospective, Randomized, Controlled Trial of Diphenhydramine and Melatonin Versus Sleep Skills Training

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 30, 2019
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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