Studying Melatonin and Recovery in Teens
SurgerySMART: Studying Melatonin and Recovery in Teens
Stanford University
45 participants
May 30, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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 Criteria11
- 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 ≥ 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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Interventions
Participants in this arm will take 3mg of melatonin in fast-dissolve pill form daily during the specified study period.
Participants in this arm will take 3mg of placebo in fast-dissolve pill form daily during the specified study period.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06093477