Using melatonin to improve recovery in teens after surgery
SurgerySMART: Studying Melatonin and Recovery in Teens
NA · Stanford University · NCT06093477
This study is testing if melatonin can help teenagers recover better and sleep well after having major surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Stanford University (other) |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT06093477 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility and acceptability of melatonin in promoting healthy sleep for adolescents undergoing major musculoskeletal surgery. A total of 45 participants aged 12-18 will be enrolled and randomized to receive either melatonin or a placebo, alongside sleep hygiene instructions. Participants will wear an actigraphy device and complete daily check-in surveys and online assessments over a four-month period to measure outcomes related to sleep, pain, and health-related quality of life. The study will assess both short-term and long-term effects of melatonin on recovery.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-18 who are scheduled for elective major musculoskeletal surgery and reside in California.
Not a fit: Patients with severe chronic medical conditions, cognitive impairments, or those currently taking sleep medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance recovery and quality of life for teens undergoing significant surgical procedures by improving their sleep quality.
How similar studies have performed: While the use of melatonin for sleep improvement is well-documented, this specific application in a surgical adolescent population is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Palo Alto, California
- Lucile Packard Children's Hospital — Palo Alto, California, United States (RECRUITING)
Study contacts
- Study coordinator: Jennifer A Rabbitts, M.B.Ch.B.
- Email: surgerysmart@stanford.edu
- Phone: (650) 427-0187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Juvenile, Scoliosis, Scoliosis Idiopathic, Adolescence, Congenital, Kyphosis, Spondylolisthesis, Pectus Surgery