NCT06093477 · Stanford University
Studying Melatonin and Recovery in Teens
(SurgerySMART)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Treatment Adherence
Time frame: Treatment phase of 14 days before surgery through 21 days after surgery (T2), and 7 days at 3-month follow-up (T3)
Youth will self-report daily medication administration on the morning and evening diaries, including the study drug as well as opioid and non-opioid analgesic medications. Medication administration will also be extracted from the EMR during hospitalization. Adherence will be measured as the percentages of doses taken.
Study Acceptability
Time frame: Assessed one time at Day 21 post-op, and at 3-month follow-up (T3)
Youth and parent will complete ratings of treatment acceptability using a 5-point scale, ranging from 1 (Strong Dislike or Strongly Disagree) to 5 (Strongly Like or Strongly Agree). A higher score indicates greater study acceptability.
Enrollment and Retention
Time frame: 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)
Research coordinators will record participant status at each stage including participants approached, assessed for eligibility, invited, consented, randomly assigned, and who received the intended treatment, and completed assessment timepoints, and will collect reasons for declining and dropout. Feasibility metrics will include enrollment rate and attrition rate.
Treatment Side Effects
Time frame: Assessed one time at Day 21 post-op, and at 3-month follow-up (T3)
Youth participants will be asked an open-ended question about side effects they may have experienced from the study drug. The rate of side effects of treatment will be self-reported by participants and extracted from EMR during hospitalization.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Palo Alto, California
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 18, 2026 · Source of record for eligibility and locations