Improving Sleep Quality After Total Joint Arthroplasty ( TJA)

Study Overview
=================
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.

Official Title
-----------------
Improving Sleep Quality After Total Joint Arthroplasty ( TJA)

Conditions
-----------------
Pain After TJA

Intervention / Treatment
-----------------
* Drug: Melatonin 5 mg
* Drug: Placebo Oral Tablet
* Drug: Magnesium 500Mg Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria -Adults 18 years and older Exclusion criteria - No chronic pain Patients underwent revision or bilateral surgery. Patients underwent fracture. Patients suffering from dementia / delirium Patients on narcotics greater than 10mg hydrocodom before surgery Not willing to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Melatonin and magnesium for 14 days | Drug: Melatonin 5 mg<br>* Melatonin is known to induce sleep<br>Drug: Magnesium 500Mg Oral Tablet<br>* 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<br>|
| Placebo Comparator: Control<br>Placebo for 14 days | Drug: Placebo Oral Tablet<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of melatonin and magnesium on pain | Effect of interventions on pain will be measured. It will done at follow up period of 2 wks, 6 wks and 3 months. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of melatonin on daily activities | Effect of interventions daily activities using VAS pain scores. Higher the score. more difficulty in performing daily activities | 90 days | 
| Effect of melatonin on daily activities | Effect of interventions on daily activities using Hip Disability and Osteoarthritis Outcome ( HOOS ) or Knee Disability and Osteoarthritis Outcome ( KOOS) score. The interval score ranges from 0 to 100 where 0 represents total hip/knee disability and 100 represents perfect hip/knee health | 90 days | 
| Effect of melatonin on daily activities | Effect of intervention on daily activities using Western Ontario and McMaster Universities Arthritis Index (WOMAC). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | 90 days | 
| Effect of melatonin on daily activities | Effect of intervention on daily activities using Pittsberg sleep quality index. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. | 90 days | 
| Effect of melatonin on daily activities | Effect of intervention on daily activities using SF 12 score. The lower the score the more disability | 90 days |