Sleep Disturbance, Total Joint Arthroplasty
Conditions
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
Interventions
DRUGmelatonin 6mg
6 weeks of melatonin (6mg) given to patient
DRUGPlacebo
Patient given 6 weeks of placebo tablet
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Sleep Quality | 6 weeks | Patients quality of sleep will be analyzed by having them answer a sleep quality index (PSQI) questionnaires |
Countries
United States
Outcome results
None listed