Improving Sleep Quality After Total Joint Arthroplasty ( TJA)

Status

Withdrawn

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03879707

Enrollment

Registered

2019-03-19

Start date

2025-06-30

Completion date

2028-06-30

Last updated

2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain After TJA

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.

Interventions

DRUGMelatonin 5 mg

Melatonin is known to induce sleep

DRUGPlacebo Oral Tablet

Placebo

DRUGMagnesium 500Mg Oral Tablet

Magnesium plays a role in supporting deep, restorative sleep by maintaining healthy levels of GABA, a neurotransmitter that promotes sleep. Research indicates supplemental magnesium can improve sleep quality, especially in people with poor sleep

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

-Adults 18 years and older

Exclusion criteria

- 1. No chronic pain 2. Patients underwent revision or bilateral surgery. 3. Patients underwent fracture. 4. Patients suffering from dementia / delirium 5. Patients on narcotics greater than 10mg hydrocodom before surgery 6. Not willing to participate

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Effect of melatonin on daily activities	90 days	Effect of interventions daily activities using VAS pain scores. Higher the score. more difficulty in performing daily activities

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026