Improving Sleep Quality After Total Joint Arthroplasty ( TJA)

Early Phase 1

Withdrawn

• Conditions: Pain After TJA
• Interventions: Drug: Melatonin 5 mg; Drug: Placebo Oral Tablet; Drug: Magnesium 500Mg Oral Tablet

• Registration Number: NCT03879707
• Lead Sponsor: Stanford University

Brief Summary

The purpose of this study is the evaluate and improve sleep quality after Total joint replacement.

Detailed Description

Patients in early stage after TKA tend to suffer from sleep problem. Sleep disturbances frequently occur in patients after surgery, and its occurrence is harmful for postoperative recovery. Many factors can affect the quality of sleep after a major surgery including anesthesia-type, narcotic use and discomfort due to pain or restricted leg movements. Pain directly leads to sleep disruption or even deprivation and, in turn, poor-quality sleep aggravates pain sensation. There seems to be a vicious circle: pain - poor-quality sleep - intensified pain - even poorer-quality sleep.

Presumably, if a patient suffers from catastrophizing, depression and anxiety , the result of TKA will be worse due to poor sleep.

Study Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-19
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18
• Study Start: 2020-06
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Melatonin 5 mg	Melatonin and magnesium for 14 days
Control	Placebo Oral Tablet	Placebo for 14 days
Experimental	Magnesium 500Mg Oral Tablet	Melatonin and magnesium for 14 days

Primary Outcome Measures

Name	Time	Method
Effect of melatonin and magnesium on pain	90 days	Effect of interventions on pain will be measured. It will done at follow up period of 2 wks, 6 wks and 3 months.

Secondary Outcome Measures

Name	Time	Method
Effect of melatonin on daily activities	90 days	Effect of intervention on daily activities using SF 12 score. The lower the score the more disability

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States