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โ† Trials
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Studying Melatonin and Recovery in Teens

RecruitingNAAges 12 Years - 18 YearsAllStanford University
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In plain words

What the trial is, and whether it could suit you

The goal of this feasibility clinical trial is to learn if melatonin can help teens having major musculoskeletal surgery by promoting healthy sleep. Melatonin is available as a dietary supplement that may be effective in promoting longer, higher quality sleep. This study will assess the feasibility and acceptability of melatonin for teens undergoing major musculoskeletal surgery, as well as determine optimal measured outcomes (sleep, pain, health-related quality of life) at short- and long-term follow-up.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Patients/youth: * Age 12-18 years * Participants undergoing elective major musculoskeletal surgery for eligible conditions * California state resident * Regular access to internet and smartphone * Can read and understand English or Spanish Parents/caregivers * Biological parent or legal guardian of youth * Can read and understand English or Spanish Exclusion Criteria: Patients/youth * Prescription medication for premorbid insomnia * Cognitive impairment or developmental delay * Does not agree to a 1-week washout if taking over the counter supplements or other sleep aids prior to the start of the study medication * High risk for sleep related breathing disorder * Chronic medical condition that is severe/systemic or requires regular treatment regimen * Psychiatric admission in prior 30 days * Patients that underwent major surgery in the last 3 months, or those that have not fully recovered from a prior surgery * BMI โ‰ฅ 99th percentile * Enrollment in another therapeutic study * Any serious underlying medical or psychiatric condition, that, in the opinion of the investigator, would contraindicate the patient's participation in the study
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What it tests

  • Fast-Dissolve Melatonin Pill
  • Fast-Dissolve Placebo Pill
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Where

1 site
Lucile Packard Children's Hospital
Palo Alto, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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