NCT06093477

Studying Melatonin and Recovery in Teens

SurgerySMART: Studying Melatonin and Recovery in Teens

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 will compare participants randomized to the placebo arm and melatonin arm to see if the trial design and outcomes are both feasible and acceptable to patients and their families. The main aims are: Aim 1. To assess the feasibility and acceptability of melatonin for youth undergoing musculoskeletal surgery Aim 2. To determine optimal primary and secondary outcomes (sleep, pain, health-related quality of life) at short-term (during the initial 21 days) and at final follow-up (3 months after surgery). The investigators will examine completion rates, the extent and pattern of missing data, and gather data to provide effect estimates, variances, and 95% confidence intervals.

Conditions

• Juvenile; Scoliosis
• Scoliosis Idiopathic
• Scoliosis; Adolescence
• Scoliosis;Congenital
• Kyphosis
• Spondylolisthesis
• Pectus Surgery
• Hip Surgery

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fast-Dissolve Melatonin Pill	Participants in this arm will take 3mg of melatonin in fast-dissolve pill form daily during the specified study period.
OTHER	Fast-Dissolve Placebo Pill	Participants in this arm will take 3mg of placebo in fast-dissolve pill form daily during the specified study period.

Timeline

• Start date: 2024-05-30
• Primary completion: 2026-10-01
• Completion: 2028-03-31
• First posted: 2023-10-23
• Last updated: 2026-03-18

Locations

1 site across 1 country: United States