Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty
NCT ID: NCT04590742
Last Updated: 2020-10-19
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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UNKNOWN
NA
154 participants
INTERVENTIONAL
2018-02-27
2021-11-30
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
NONE
Study Groups
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Group 1
Placebo Tablet
Placebo
Patient given 6 weeks of placebo tablet
Group 2
Melatonin (6mg)
melatonin 6mg
6 weeks of melatonin (6mg) given to patient
Interventions
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melatonin 6mg
6 weeks of melatonin (6mg) given to patient
Placebo
Patient given 6 weeks of placebo tablet
Eligibility Criteria
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Inclusion Criteria
2. Patient willing and able to complete postoperative surveys
Exclusion Criteria
2. Patients who undergo bilateral total joint arthroplasty
3. Patients currently taking melatonin supplementation
4. Patient has history of substance abuse (drug or alcohol)
5. Patient is a workman's comp patient or patient has current litigation pending
6. Patient has an allergy to melatonin
7. Patient has a history of delirium/psychiatric/depression/on antidepressants
8. Patient has a history of insomnia/ on sleep aid medication
9. Anyone on warfarin
10. Sleep apnea
11. Patient discharged to SNF or rehab
12. Patients who have inflammatory conditions
13. Shift work or night work
18 Years
99 Years
ALL
Yes
Sponsors
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Rothman Institute Orthopaedics
OTHER
Responsible Party
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Locations
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Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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JJP17D.511
Identifier Type: -
Identifier Source: org_study_id
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