Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty

Not Applicable

• Conditions: Sleep Disturbance; Total Joint Arthroplasty
• Interventions: Drug: Placebo; Drug: melatonin 6mg

• Registration Number: NCT04590742
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

The purpose of this study is to determine whether melatonin when used as a supplement after surgery improves sleep following total joint arthroplasty

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-27
• Status Verified: 2020-10
• Study First Submitted: 2020-10-12
• Study First Submitted QC: 2020-10-15
• Last Update Submitted: 2020-10-15
• Study First Posted: 2020-10-19
• Last Update Posted: 2020-10-19
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

1. Patients who undergo unilateral primary total joint arthroplasty
2. Patient willing and able to complete postoperative surveys

Exclusion Criteria

1. Patients who undergo revision total joint arthroplasty
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Placebo	Placebo Tablet
Group 2	melatonin 6mg	Melatonin (6mg)

Primary Outcome Measures

Name	Time	Method
Patient Sleep Quality	6 weeks	Patients quality of sleep will be analyzed by having them answer a sleep quality index (PSQI) questionnaires

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States