Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
55 participants
INTERVENTIONAL
2019-10-01
2022-05-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
2. Sleep Hygiene Education Group
3. Control group (Usual Care)
Study Groups
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Control group (Usual Care)
Control Group (Usual Care): Participants do not use any type of sleep education or non-prescription sleep medications to assist with getting a "good night's sleep".
No interventions assigned to this group
Sleep Hygiene Education
Sleep Hygiene Education: Participants are provided a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
Sleep Hygiene Education
Brochure containing information about getting a "good night's sleep."
Over-the-counter sleep aids (25 mg Benadryl + 3mg 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."
Diphenhydramine (Benadryl)
Oral Diphenhydramine (Benadryl), 25 mg
Melatonin
Oral Melatonin, 3 mg
Sleep Hygiene Education
Brochure containing information about getting a "good night's sleep."
Interventions
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Diphenhydramine (Benadryl)
Oral Diphenhydramine (Benadryl), 25 mg
Melatonin
Oral Melatonin, 3 mg
Sleep Hygiene Education
Brochure containing information about getting a "good night's sleep."
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Workman's compensation patients
3. Revision joint replacement
4. History of prescription or over-the- counter sleep aid use
18 Years
ALL
No
Sponsors
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James A. Keeney
OTHER
Responsible Party
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James A. Keeney
Chief Adult Hip and Knee Reconstruction Service, Department of Orthopaedic Surgery, University of Missouri
Locations
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Vicki L Jones
Columbia, Missouri, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2013726
Identifier Type: -
Identifier Source: org_study_id
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