Education and Training
Studying Melatonin and Recovery in Teens
The goal of this feasibility clinical trial is to learn if melatonin can help teens having spinal fusion 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 spinal fusion surgery, as well as determine optimal measured outcomes (sleep, pain, health-related quality of life) at short- and long-term follow-up.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- dietary supplement: Melatonin
- other: Syrup
Eligibility
Inclusion Criteria:
Patients/youth:
- Age 12-18 years
- Participants undergoing elective spinal fusion 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
Ages Eligible for Study
12 Years - 18 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jennifer A Rabbitts, M.D.
650-725-0540
Not Recruiting