Studying Melatonin to Improve Sleep and Recovery in Teens Undergoing Major Musculoskeletal Surgery

What this Trial Is About

Researchers are evaluating whether melatonin can help teenagers undergoing major musculoskeletal surgery by improving their sleep. This feasibility clinical trial focuses on adolescents aged 12 to 18 who are scheduled for elective surgery for conditions such as scoliosis, kyphosis, spondylolisthesis, pectus surgery, or hip surgery. The study aims to assess how acceptable and practical melatonin use is for these youths and to identify the best ways to measure outcomes related to sleep, pain, and quality of life both shortly after surgery and months later. Participants will be randomly assigned to take either a 3mg fast-dissolve melatonin pill or a placebo pill daily before and after surgery. All participants will receive instructions on good sleep habits. They will wear an actigraphy device, which is like a watch, to monitor sleep patterns before and after surgery. The study includes a treatment phase starting 14 days before surgery and continuing 21 days after, as well as follow-up periods up to 3 months post-surgery. Teens and one of their caregivers will complete brief surveys twice daily for about five weeks and longer online surveys three times over four months. Researchers will monitor treatment adherence, side effects, study acceptability, and retention. They will also assess changes in sleep quality and duration, pain levels, and health-related quality of life. The total study duration involves activities from before surgery through a 3-month follow-up to gather comprehensive data on recovery and well-being.

Studying Melatonin and Recovery in Teens