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The purpose of this study is the evaluate and improve sleep quality after Total joint replacement.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Melatonin and magnesium for 14 days |
|
| Control | Placebo Comparator | Placebo for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin 5 mg | Drug | Melatonin is known to induce sleep |
| |
| 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 |
| 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 |
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Inclusion criteria -Adults 18 years and older
Exclusion criteria -
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| Name | Affiliation | Role |
|---|---|---|
| Derek Amanatullah, M.D. PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D008274 | Magnesium |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo Oral Tablet |
| Drug |
Placebo |
|
| Magnesium 500Mg Oral Tablet | Drug | 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 |
|
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 |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |