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Studying Melatonin and Recovery in Teens — SurgerySMART  

Spondylolisthesis Clinical Trial

Official title:
SurgerySMART: Studying Melatonin and Recovery in Teens

Clinical Trial Summary

The goal of this feasibility clinical trial is to learn if melatonin can help teens having spinal fusion 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 spinal fusion surgery, as well as determine optimal measured outcomes (sleep, pain, health-related quality of life) at short- and long-term follow-up.

Clinical Trial Description

The investigators will enroll a total of 40 adolescents ages 12-18 years old who are scheduled to undergo spinal fusion 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06093477
Study type Interventional
Source Stanford University
Contact Study Team
Phone 650-725-0540
Email rabbittslab@stanford.edu
Status Not yet recruiting
Phase N/A
Start date July 2024
Completion date June 2028
View Details
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