An interventional study of Fast-Dissolve Melatonin Pill and Fast-Dissolve Placebo Pill in Juvenile; Scoliosis, Scoliosis Idiopathic and Scoliosis; Adolescence, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Stanford University · Not applicable, Interventional, and Other
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.
The investigators will enroll a total of 45 adolescents ages 12-18 years old who are scheduled to undergo major musculoskeletal surgery and one of their caregivers who meet inclusion and exclusion criteria. Participants will be asked to:
Researchers will compare participants randomized to the placebo arm and melatonin arm to see if the trial design and outcomes are both feasible and acceptable to patients and their families.
The main aims are:
Aim 1. To assess the feasibility and acceptability of melatonin for youth undergoing musculoskeletal surgery Aim 2. To determine optimal primary and secondary outcomes (sleep, pain, health-related quality of life) at short-term (during the initial 21 days) and at final follow-up (3 months after surgery). The investigators will examine completion rates, the extent and pattern of missing data, and gather data to provide effect estimates, variances, and 95% confidence intervals.
660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.
This study's planned enrollment of 45 is close to the median of 45 across 386 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients/youth:
Parents/caregivers
Exclusion Criteria:
Patients/youth
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will take a placebo of 3mg fast-dissolve pill (without melatonin), complete surveys, and wear an actigraphy device during the specified study period.
Other: Fast-Dissolve Placebo Pill
Participants will take 3mg in fast-dissolve pill form containing the active ingredient melatonin, complete surveys, and wear an actigraphy device during the specified study period.
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.
Participants in this arm will take 3mg of placebo in fast-dissolve pill form daily during the specified study period.
Treatment Adherence
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.
Time frame: Treatment phase of 14 days before surgery through 21 days after surgery (T2), and 7 days at 3-month follow-up (T3)
Study Acceptability
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.
Time frame: Assessed one time at Day 21 post-op, and at 3-month follow-up (T3)
Enrollment and Retention
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.
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)
Treatment Side Effects
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.
Time frame: Assessed one time at Day 21 post-op, and at 3-month follow-up (T3)
Change in Sleep Quality
Youth will complete the Adolescent Sleep Wake Scale (ASWS), a 10-item measure of sleep quality over the past month rated on a 6-point Likert scale ranging from "Always" to "Never". The measure assesses five behavioral dimensions of sleep quality: (1) going to bed, (2) falling asleep/latency, (3) maintaining sleep, (4) re-initiating sleep, and (5) returning to wakefulness, and yields a total sleep quality score.
Time frame: Pre-treatment (T1) and one time at 3-month follow-up (T3)
Change in Peri-operative Sleep Quality
Youth will complete once daily online diaries assessing daily sleep quality in the morning. Sleep quality will be rated on an 11-point scale ranging from 0 (Extremely poor sleep) to 10 (Extremely good sleep). A higher score indicates higher quality sleep.
Time frame: Treatment phase of 14 days before surgery through 21 days post-op (T2) and 7 days at 3-month follow-up (T3)
Change in Sleep Duration
Youth will wear an actigraphy monitor to measure sleep duration. Youth will also report on sleep and wake times on the online morning diary, which will be used to assist with actigraphy scoring. Actigraphic sleep variables will include: minutes of estimated sleep, and sleep efficiency.
Time frame: Treatment phase of 14 days before surgery through 21 days post-op (T2) and 7 days at 3-month follow-up (T3)
Change in Health-related Quality of Life
Youth will complete the Pediatric Quality of Life Inventory (PedsQL), a 15-item measure that assesses self-reported physical, social, and emotional health-related qualify of life over the prior 7 days. The measure yields Physical Health, Psychosocial Health, and Total Health summary scores. The PedsQL is widely used and demonstrates good reliability for both the parent and child self-report measures. Scale scores range from 0 to 100. Higher scores indicate fewer difficulties (better) health-related quality of life.
Time frame: Pre-treatment (T1) and one time at 3-month follow-up (T3)
Change in Global Pain Severity
Youth will complete the Global Impression of Severity, a single item measure that assesses self-reported patient global impression of pain severity in the preceding 7 days. Response options range from 0 (none) to 3 (severe) with higher scores indicating higher pain severity.
Time frame: Pre-treatment (T1), one time at Day 21 post-op (T2), and one time at 3-month follow-up (T3)
Change in Pain Intensity and Interference
Youth will complete the Brief Pain Inventory (BPI), which assesses worst, least, average, and current pain intensity (4 items) and pain interference on daily functions (7 items) in the prior 7 days, with response options indicated on 11-point NRS. Items are averaged to yield scale scores, ranging from 0 to 10, with higher scores indicating greater pain intensity or interference.
Time frame: Baseline pre-surgery assessment (T1), treatment phase of 14 days before surgery through 21 days after surgery (T2), and 7 days at 3-month follow-up (T3)
Adverse Events
Youth and parents will be asked questions about adverse events.
Time frame: Assessed one time at 3-month follow-up (T3)
Concomitant therapy
Youth and parents will be asked open-ended questions about concomitant therapies the patient may have taken (use of sleep aids).
Time frame: Assessed one time at 21 days post-op (T2) and one time at 3-month follow-up (T3)
Pediatric Anxiety
Youth will complete the PROMIS Anxiety Short Form 8a, which assesses the pure domain of anxiety in children and adolescents (8 items) in the prior 7 days, with response options indicated on a 5-point scale. Higher scores indicate greater severity of anxiety. Response options range from 1 (Never) to 5 (Almost Always). Raw scores for anxiety and depression are obtained by summing the corresponding items' response values, and range from 8 to 40 with higher scores indicating higher distress.
Time frame: Assessed one time on day before surgery (T2)
Plan to share: Yes — The study team will follow the NIH (NATIONAL INSTITUTES OF HEALTH) Policy on the Dissemination of NIH-Funded Clinical Trial Information (Clinical Trials Policy) by producing a sharable database as soon as possible upon publication of the primary analyses. To protect participants' privacy, the dataset available for sharing will be deidentified at the aggregate level of the underlying primary data (demographic data, summary scores on survey measures, summary of actigraphy data) according to definitions provided in the Health Insurance Portability and Accountability Act (HIPAA). Namely, all identifiers specified in HIPAA will be re-coded in a manner that will make it impossible to deduce or impute the specific identity of any participant. The database will not contain any institutional identifiers. Data elements that are considered unreliable will be deleted to foster ease of data reuse. Informed consent forms will reflect plans for de-identification and aggregate sharing.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Shared data generated from this project will be available as soon as possible, and no later than the time of publication of the analyses examining the study's primary aims. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.
Access criteria: Data will be made available in a data repository which allows research teams to restrict access to the data to qualified investigators with an appropriate research question and approved data use agreement. The data use agreement limits subsequent use to the terms of the approved request and requires that users maintain data security and refrain from any attempts to re-identify research participants or engage in any unauthorized use of the data. PI Dr. Jennifer Rabbitts, ORCID: https://orcid.org/0000-0003-4800-1080, will oversee day-to-day data management activities and data sharing. Dr. Rabbitts will also oversee broader issues of DMS (Data Management and Sharing) Plan compliance oversight reporting which will include maintaining databases, as part of general data stewardship, reporting, and compliance processes.
Started May 2024 (actual). Primary completion is estimated for Jun 2027, 36 months after the start.
Of 223 non-industry interventional studies with no phase under Scoliosis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 58. This study's planned 36 months is above that.
Counting every sponsor, half of 233 studies reached it within 22 months; a quarter within 8 and three quarters within 60.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 27, 2026: primary completion Oct 2026 → Jun 2027 and completion Mar 2028 → Oct 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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