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Trial record 51 of 449 for:    diphenhydramine

Total Joint Arthroplasty and Sleep

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03968939
Recruitment Status : Not yet recruiting
First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Information provided by (Responsible Party):
James A. Keeney, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Primary Total Hip Arthroplasty Primary Total Knee Arthroplasty Drug: Diphenhydramine (Benadryl) Dietary Supplement: Melatonin Behavioral: Sleep Hygiene Education Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
  1. Benadryl + Melatonin Group + Sleep Hygiene Education
  2. Placebo + Sleep Hygiene Education Group
  3. Control group (Usual Care)
Primary Purpose: Treatment
Official Title: Postoperative Sleep Quality Following Total Joint Arthroplasty: A Prospective, Randomized, Controlled Trial of Diphenhydramine and Melatonin Versus Sleep Skills Training
Estimated Study Start Date : May 30, 2019
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021

Arm Intervention/treatment
No Intervention: Control group (Usual Care)
Placebo Comparator: Placebo + Sleep Hygiene Education Behavioral: Sleep Hygiene Education
Brochure containing information about getting a "good night's sleep."

Active Comparator: Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin) Drug: Diphenhydramine (Benadryl)
Oral Diphenhydramine (Benadryl), 25 mg

Dietary Supplement: Melatonin
Oral Melatonin, 3 mg

Behavioral: Sleep Hygiene Education
Brochure containing information about getting a "good night's sleep."

Primary Outcome Measures :
  1. Epworth Sleepiness Scale (ESS) [ Time Frame: 12 weeks post-op ]

    Patient Reported Outcome Measure - assess the "daytime sleepiness of the patient"

    Scale: 0-3. 0 being never dose, 3 being high chance of dozing

  2. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 12 weeks post-op ]

    Patient Reported Outcome Measure - measure the quality and patterns of sleep in the older adult

    Scale: 0-3. 0 no trouble sleeping in the past month/very good sleep, 3 three or more times having trouble sleeping in the past month/very bad sleep

  3. Visual Analogue Scale (VAS) for pain [ Time Frame: 12 weeks post-op ]
    Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

All patients undergoing elective primary total hip or knee arthroplasty

Exclusion Criteria:

  1. History of substance abuse
  2. Workman's compensation patients
  3. Revision joint replacement
  4. History of prescription or over-the- counter sleep aid use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03968939

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Contact: Stacee W Clawson, BSN, RN 573-884-9017

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United States, Missouri
University of Missouri Health System
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
James A. Keeney
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Principal Investigator: James A Keeney, MD University of Missouri Health System, Department of Orthopaedic Surgery

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Responsible Party: James A. Keeney, Chief Adult Hip and Knee Reconstruction Service, Department of Orthopaedic Surgery, University of Missouri, University of Missouri-Columbia Identifier: NCT03968939     History of Changes
Other Study ID Numbers: 2013726
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Sleep Aids, Pharmaceutical
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Anti-Allergic Agents
Dermatologic Agents