Juvenile; Scoliosis study: Fast-Dissolve Melatonin Pill
Official title Studying Melatonin and Recovery in Teens
ClinicalTrials.gov ID: NCT06093477
What this study is testing
- What it's testing
- The study will see if melatonin is feasible and acceptable for teens after major musculoskeletal surgery and will measure sleep, pain, and quality of life at short and long‑term follow‑up.
- Who it's for
- Teens who are having major musculoskeletal surgery such as scoliosis, kyphosis, spondylolisthesis, pectus or hip surgery
- What's involved
- Participants will take a melatonin supplement and attend scheduled visits for sleep, pain, and quality‑of‑life assessments, along with routine post‑surgery care
- Time commitment
- The study lasts from before surgery through follow‑up visits over several months, with several clinic visits and questionnaires during recovery
- Time commitment: about 4 months
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Palo Alto, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 4 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Palo Alto, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.