Treatment for Sleep Disturbance in Orthopaedic Trauma Patients
NCT ID: NCT03779243
Last Updated: 2021-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2019-01-07
2021-08-24
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
Study Groups
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5mg Melatonin and Sleep Education
Participants will take 5mg Melatonin nightly, 1 hour before bedtime and be provided educational materials to improve sleep hygiene. They will have study visits in clinic as part of standard-of-care at 6 weeks and 12 weeks. They will complete Pittsburgh Sleep Quality Index and SF-36 Quality of Life questionnaires at enrollment and at their clinic visits.
Melatonin 5mg and Sleep Education
Melatonin 5mg daily and sleep education for 6 weeks following injury or surgery.
Placebo Control
Participants will be given placebo pills to be taken daily 1 hour before bedtime and are a "sleep aid". Participants will not receive any sleep education materials. They will have study visits in clinic as part of standard-of-care at 6 weeks and 12 weeks. They will complete Pittsburgh Sleep Quality Index and SF-36 Quality of Life questionnaires at enrollment and at their clinic visits.
Placebo
Daily placebo pills for 6 weeks following injury or surgery.
Interventions
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Melatonin 5mg and Sleep Education
Melatonin 5mg daily and sleep education for 6 weeks following injury or surgery.
Placebo
Daily placebo pills for 6 weeks following injury or surgery.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Michael J. Gardner
PROFESSOR OF ORTHOPAEDIC SURGERY AT THE STANFORD UNIVERSITY MEDICAL CENTER
Principal Investigators
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Michael J Gardner, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford Department of Orthopaedic Surgery
Locations
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Stanford
Stanford, California, United States
Countries
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References
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Swann MC, Batty M, Hu G, Mitchell T, Box H, Starr A. Sleep Disturbance in Orthopaedic Trauma Patients. J Orthop Trauma. 2018 Oct;32(10):500-504. doi: 10.1097/BOT.0000000000001276.
Other Identifiers
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IRB-48700
Identifier Type: -
Identifier Source: org_study_id