Studying Melatonin and Recovery in Teens

Launched by STANFORD UNIVERSITY · Oct 16, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at whether melatonin can help teens who are having major surgeries on their bones and muscles get better sleep. Melatonin is a natural supplement that may help people sleep longer and better. The researchers want to see if giving melatonin to teens before and after their surgery can improve their sleep quality, reduce pain, and enhance their overall recovery and quality of life.

To be part of this study, teens need to be between 12 and 18 years old, live in California, and have access to the internet and a smartphone. They should be scheduled for elective major musculoskeletal surgery, such as for scoliosis or hip issues. Participants will need to be able to read and understand English. Importantly, they should not have been taking certain sleep medications or have serious health issues that could interfere with the study. If eligible, participants can expect to receive melatonin and will be monitored for improvements in their sleep and recovery both shortly after surgery and in the long term.

Gender

ALL

Eligibility criteria

• 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
• • Parents/caregivers
• • Biological parent or legal guardian of youth
• • Can read and understand English
• 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 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