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Melatonin and Recovery in Teens After Surgery

This study is looking at whether a fast-dissolve melatonin pill can help teenagers (ages 12-18) recover after major bone or muscle surgery. Melatonin is a dietary supplement that might improve sleep. Researchers want to see if giving teens 3mg of melatonin daily before and after surgery is practical and acceptable to them and their families. They also want to figure out the best ways to measure sleep, pain, and quality of life in these teens. You might be able to join if you are a California resident, aged 12-18, having major musculoskeletal surgery, and can use a smartphone and read English or Spanish. The study is currently unclear about its recruitment status and plans to enroll 45 participants.

Study design
This is an interventional study involving 45 participants, where some will receive a fast-dissolve melatonin pill and others a fast-dissolve placebo pill. It is designed to assess the feasibility and acceptability of the intervention.
What's involved
You would take melatonin or a placebo daily, wear a watch-like device, complete short daily check-in surveys for about 5 weeks, and fill out longer online surveys three times over four months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 21 days after surgery and then again at a 3-month follow-up.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06093477

Studying Melatonin and Recovery in Teens

Recruiting
NAAges 12–18Interventional
Stanford University
~45 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:Fast-Dissolve Melatonin PillFast-Dissolve Placebo Pill

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment Adherence
Measured over Treatment phase of 14 days before surgery through 21 days after surgery (T2), and 7 days at 3-month follow-up (T3)
+3 more outcomes measured

Conditions

Juvenile; Scoliosis
Scoliosis Idiopathic
Scoliosis; Adolescence
Scoliosis;Congenital
Kyphosis
Spondylolisthesis
Pectus Surgery
Hip Surgery

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KyphosisLip DisorderPectus ExcavatumScoliosisSpondylolisthesis

Where it's being run

1 sites across 1 states
California1

Who to contact

Jennifer A Rabbitts, M.B.Ch.B.
[email protected]
(650) 427-0187
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Biological parent or legal guardian of youth
Can read and understand English or Spanish

Exclusion

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

What this trial measures

  • Treatment AdherenceTreatment 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 AcceptabilityAssessed 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 RetentionPre-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 EffectsAssessed 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.