SurgerySMART: Studying Melatonin and Recovery in Teens
Stanford University
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.
Description
The investigators will enroll a total of 45 adolescents ages 12-18 years old who are scheduled to undergo major musculoskeletal surgery and one of their caregivers who meet inclusion and exclusion criteria. Participants will be asked to: 1. Take melatonin or a placebo before and after surgery. All participants will receive sleep hygiene instructions. 2. Wear a watch-like actigraphy device before and after surgery 3. Complete 1-minute check-in surveys twice each day, for about 5 weeks total before and after surgery 4. Complete 10-20-minute online surveys 3 times over 4 months. Researchers wil…
Eligibility
- Age range
- 12–18 years
- Sex
- All
- Healthy volunteers
- No
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 a…
Interventions
- Dietary SupplementFast-Dissolve Melatonin Pill
Participants in this arm will take 3mg of melatonin in fast-dissolve pill form daily during the specified study period.
- OtherFast-Dissolve Placebo Pill
Participants in this arm will take 3mg of placebo in fast-dissolve pill form daily during the specified study period.
Location
- Lucile Packard Children's HospitalPalo Alto, California