The purpose of the study is to test the efficacy of sleep treatment in human patients following traumatic injury. Specifically, the study will determine if treatment consisting of melatonin and education related to sleep habits are effective in treating sleep disturbance and improving sleep quality in Orthopaedic trauma patients. We hope to learn if melatonin and sleep education effectively improve sleep following traumatic injury, and improve outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Melatonin 5mg daily and sleep education for 6 weeks following injury or surgery.
Daily placebo pills for 6 weeks following injury or surgery.
Stanford
Stanford, California, United States
Mean Change in Pittsburgh Sleep Quality Index Score
9-item self-rated questionnaire that assesses clinical sleep quality and disturbances. Global PSQI scores are sums of the component scores, and range from 0-21. Higher scores indicate worse sleep quality.
Time frame: Baseline, week 6, and week 12
36-Item Short Form Survey (SF-36) to measure quality of life
36-item, patient-reported survey of patient health-related quality of life.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time frame: Baseline, week 6, and week 12
Mean Change from Baseline in Pain Scores on the Visual Analog Scale (VAS)
VAS is scored on a continuum from 0-10 indicating "no pain" to "unbearable pain". Higher scores indicate more pain intensity.
Time frame: Baseline, week 6, and week 12
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