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Juvenile; ScoliosisSurgerySMARTNCT06093477

Studying Melatonin and Recovery in Teens

A study testing Fast-Dissolve Melatonin Pill in people with Juvenile; Scoliosis and Scoliosis Idiopathic, run by Stanford University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 18 years
What is being tested?
Fast-Dissolve Melatonin Pill
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteUnited States
Study dates
30 May 2024to 31 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Parents/caregivers
  • Biological parent or legal guardian of youth
  • Can read and understand English or Spanish

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer A Rabbitts, M.B.Ch.B. contact

(650) 427-0187

surgerysmart@stanford.edu

United States1 site, 1 recruiting

  • Lucile Packard Children's Hospital

    Palo Alto, California, 94304

    Jennifer A Rabbitts, M.D., 650-725-0540, rabbitts@stanford.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Fast-Dissolve Melatonin Pill, Fast-Dissolve Placebo Pill
Keywords
sleep, pain medicine, pediatric pain medicine, melatonin, pilot feasibility trial, acute pain, chronic pain, CPSP, chronic postsurgical pain, spinal fusion surgery, adolescent, perioperative melatonin, hip surgery, pectus surgery
Medical subject headings
Scoliosis, Kyphosis, Spondylolisthesis, Acute Pain, Chronic Pain, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fast-Dissolve Melatonin PillDietary supplement

    Participants in this arm will take 3mg of melatonin in fast-dissolve pill form daily during the specified study period.

  • Fast-Dissolve Placebo PillOther

    Participants in this arm will take 3mg of placebo in fast-dissolve pill form daily during the specified study period.

Study groups in NCT06093477
Study groupRoleWhat they receive
3mg fast-dissolve pillPlacebo comparatorParticipants will take a placebo of 3mg fast-dissolve pill (without melatonin), complete surveys, and wear an actigraphy device during the specified study period.
Receives: Other: Fast-Dissolve Placebo Pill
3mg fast-dissolve pill (containing melatonin)ExperimentalParticipants 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.
Receives: Dietary Supplement: Fast-Dissolve Melatonin Pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Treatment phase of 14 days before surgery through 21 days after surgery (T2), and 7 days at 3-month follow-up (T3)

  2. 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.

    Measured: Assessed one time at Day 21 post-op, and at 3-month follow-up (T3)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: Assessed one time at Day 21 post-op, and at 3-month follow-up (T3)

Secondary outcomes (6)

  1. 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.

    Measured: Pre-treatment (T1) and one time at 3-month follow-up (T3)

  2. 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.

    Measured: Treatment phase of 14 days before surgery through 21 days post-op (T2) and 7 days at 3-month follow-up (T3)

  3. 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.

    Measured: Treatment phase of 14 days before surgery through 21 days post-op (T2) and 7 days at 3-month follow-up (T3)

  4. 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.

    Measured: Pre-treatment (T1) and one time at 3-month follow-up (T3)

  5. 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.

    Measured: Pre-treatment (T1), one time at Day 21 post-op (T2), and one time at 3-month follow-up (T3)

  6. 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start30 May 2024
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06093477
Sponsor's protocol ID
IRB-71745
Other IDs
7K24AR080786-02
Acronym
SurgerySMART
Status last verified
Oct 2026
First submitted
9 Oct 2023
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Haack M, Simpson N, Sethna N, Kaur S, Mullington J. Sleep deficiency and chronic pain: potential underlying mechanisms and clinical implications. Neuropsychopharmacology. 2020 Jan;45(1):205-216. doi: 10.1038/s41386-019-0439-z. Epub 2019 Jun 17.

    PubMed 31207606

  • Moore S, Stockbridge L. Fresnel prisms in the management of combined horizontal and vertical strabismus. Am Orthopt J. 1972;22:14-21. No abstract available.

    PubMed 5052847

  • Nabavi SM, Nabavi SF, Sureda A, Xiao J, Dehpour AR, Shirooie S, Silva AS, Baldi A, Khan H, Daglia M. Anti-inflammatory effects of Melatonin: A mechanistic review. Crit Rev Food Sci Nutr. 2019;59(sup1):S4-S16. doi: 10.1080/10408398.2018.1487927. Epub 2019 Mar 21.

    PubMed 29902071

  • Madsen BK, Zetner D, Moller AM, Rosenberg J. Melatonin for preoperative and postoperative anxiety in adults. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009861. doi: 10.1002/14651858.CD009861.pub3.

    PubMed 33319916

  • Yousaf F, Seet E, Venkatraghavan L, Abrishami A, Chung F. Efficacy and safety of melatonin as an anxiolytic and analgesic in the perioperative period: a qualitative systematic review of randomized trials. Anesthesiology. 2010 Oct;113(4):968-76. doi: 10.1097/ALN.0b013e3181e7d626.

    PubMed 20823763

  • Andersen LP, Werner MU, Rosenberg J, Gogenur I. A systematic review of peri-operative melatonin. Anaesthesia. 2014 Oct;69(10):1163-71. doi: 10.1111/anae.12717. Epub 2014 May 19.

    PubMed 24835540

  • Caumo W, Torres F, Moreira NL Jr, Auzani JA, Monteiro CA, Londero G, Ribeiro DF, Hidalgo MP. The clinical impact of preoperative melatonin on postoperative outcomes in patients undergoing abdominal hysterectomy. Anesth Analg. 2007 Nov;105(5):1263-71, table of contents. doi: 10.1213/01.ane.0000282834.78456.90.

    PubMed 17959953

  • Caumo W, Levandovski R, Hidalgo MP. Preoperative anxiolytic effect of melatonin and clonidine on postoperative pain and morphine consumption in patients undergoing abdominal hysterectomy: a double-blind, randomized, placebo-controlled study. J Pain. 2009 Jan;10(1):100-8. doi: 10.1016/j.jpain.2008.08.007. Epub 2008 Nov 17.

    PubMed 19010741

  • Barlow KM, Brooks BL, Esser MJ, Kirton A, Mikrogianakis A, Zemek RL, MacMaster FP, Nettel-Aguirre A, Yeates KO, Kirk V, Hutchison JS, Crawford S, Turley B, Cameron C, Hill MD, Samuel T, Buchhalter J, Richer L, Platt R, Boyd R, Dewey D. Efficacy of Melatonin in Children With Postconcussive Symptoms: A Randomized Clinical Trial. Pediatrics. 2020 Apr;145(4):e20192812. doi: 10.1542/peds.2019-2812. Epub 2020 Mar 26.

    PubMed 32217739

  • Buscemi N, Vandermeer B, Hooton N, Pandya R, Tjosvold L, Hartling L, Baker G, Klassen TP, Vohra S. The efficacy and safety of exogenous melatonin for primary sleep disorders. A meta-analysis. J Gen Intern Med. 2005 Dec;20(12):1151-8. doi: 10.1111/j.1525-1497.2005.0243.x.

    PubMed 16423108

  • Wei S, Smits MG, Tang X, Kuang L, Meng H, Ni S, Xiao M, Zhou X. Efficacy and safety of melatonin for sleep onset insomnia in children and adolescents: a meta-analysis of randomized controlled trials. Sleep Med. 2020 Apr;68:1-8. doi: 10.1016/j.sleep.2019.02.017. Epub 2019 Mar 9.

    PubMed 31982807

  • Smits MG, van Stel HF, van der Heijden K, Meijer AM, Coenen AM, Kerkhof GA. Melatonin improves health status and sleep in children with idiopathic chronic sleep-onset insomnia: a randomized placebo-controlled trial. J Am Acad Child Adolesc Psychiatry. 2003 Nov;42(11):1286-93. doi: 10.1097/01.chi.0000085756.71002.86.

    PubMed 14566165

  • Smits MG, Nagtegaal EE, van der Heijden J, Coenen AM, Kerkhof GA. Melatonin for chronic sleep onset insomnia in children: a randomized placebo-controlled trial. J Child Neurol. 2001 Feb;16(2):86-92. doi: 10.1177/088307380101600204.

    PubMed 11292231

  • Karkela J, Vakkuri O, Kaukinen S, Huang WQ, Pasanen M. The influence of anaesthesia and surgery on the circadian rhythm of melatonin. Acta Anaesthesiol Scand. 2002 Jan;46(1):30-6. doi: 10.1034/j.1399-6576.2002.460106.x.

    PubMed 11903069

  • Rabbitts JA, Groenewald CB, Tai GG, Palermo TM. Presurgical psychosocial predictors of acute postsurgical pain and quality of life in children undergoing major surgery. J Pain. 2015 Mar;16(3):226-34. doi: 10.1016/j.jpain.2014.11.015. Epub 2014 Dec 22.

    PubMed 25540939

Questions about this trial

What is this clinical trial studying?

A study testing Fast-Dissolve Melatonin Pill in people with Juvenile; Scoliosis and Scoliosis Idiopathic, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer A Rabbitts, M.B.Ch.B. ((650) 427-0187, surgerysmart@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06093477, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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