Studying Melatonin and Recovery in Teens (SurgerySMART)

March 16, 2026 updated by: Jennifer Rabbitts, Stanford University

SurgerySMART: Studying Melatonin and Recovery in Teens

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  1. Take melatonin or a placebo before and after surgery. All participants will receive sleep hygiene instructions.
  2. Wear a watch-like actigraphy device before and after surgery
  3. Complete 1-minute check-in surveys twice each day, for about 5 weeks total before and after surgery
  4. Complete 10-20-minute online surveys 3 times over 4 months.

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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Lucile Packard Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3mg fast-dissolve pill
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 in this arm will take 3mg of placebo in fast-dissolve pill form daily during the specified study period.
Experimental: 3mg fast-dissolve pill (containing melatonin)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment and Retention
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)
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.
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 Adherence
Time Frame: Treatment 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.
Treatment phase of 14 days before surgery through 21 days after surgery (T2), and 7 days at 3-month follow-up (T3)
Study Acceptability
Time Frame: Assessed 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.
Assessed one time at Day 21 post-op, and at 3-month follow-up (T3)
Treatment Side Effects
Time Frame: Assessed 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.
Assessed one time at Day 21 post-op, and at 3-month follow-up (T3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sleep Quality
Time Frame: Pre-treatment (T1) and one time at 3-month follow-up (T3)
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.
Pre-treatment (T1) and one time at 3-month follow-up (T3)
Change in Peri-operative Sleep Quality
Time Frame: Treatment phase of 14 days before surgery through 21 days post-op (T2) and 7 days at 3-month follow-up (T3)
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.
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
Time Frame: Treatment phase of 14 days before surgery through 21 days post-op (T2) and 7 days at 3-month follow-up (T3)
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.
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
Time Frame: Pre-treatment (T1) and one time at 3-month follow-up (T3)
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.
Pre-treatment (T1) and one time at 3-month follow-up (T3)
Change in Global Pain Severity
Time Frame: Pre-treatment (T1), one time at Day 21 post-op (T2), and one time at 3-month follow-up (T3)
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.
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
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)
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.
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concomitant therapy
Time Frame: Assessed one time at 21 days post-op (T2) and one time at 3-month follow-up (T3)
Youth and parents will be asked open-ended questions about concomitant therapies the patient may have taken (use of sleep aids).
Assessed one time at 21 days post-op (T2) and one time at 3-month follow-up (T3)
Pediatric Anxiety
Time Frame: Assessed one time on day before surgery (T2)
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.
Assessed one time on day before surgery (T2)
Adverse Events
Time Frame: Assessed one time at 3-month follow-up (T3)
Youth and parents will be asked questions about adverse events.
Assessed one time at 3-month follow-up (T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: Jennifer A Rabbitts, M.B.Ch.B., Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-71745
  • 7K24AR080786-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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