Studying Melatonin and Recovery in Teens (NCT06093477) | Clinical Trial Compass
RecruitingNot Applicable
Studying Melatonin and Recovery in Teens
United States45 participantsStarted 2024-05-30
Plain-language 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.
Who can participate
Age range
12 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment Adherence
Timeframe: Treatment phase of 14 days before surgery through 21 days after surgery (T2), and 7 days at 3-month follow-up (T3)
2
Study Acceptability
Timeframe: Assessed one time at Day 21 post-op, and at 3-month follow-up (T3)
3
Enrollment and Retention
Timeframe: Pre-treatment (T1), treatment phase of 14 days before surgery through 21 days after surgery (T2), and 7 days at 3-month follow-up (T3)
4
Treatment Side Effects
Timeframe: Assessed one time at Day 21 post-op, and at 3-month follow-up (T3)