Actively Recruiting

Phase Not Applicable
Age: 12Years - 18Years
All Genders
ID06093477

SurgerySMART: Studying Melatonin and Recovery in Teens

Led by Stanford University · Updated on 2026-03-18

45

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

S

Stanford University

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether melatonin can help teenagers undergoing major musculoskeletal surgery by improving their sleep. This feasibility clinical trial focuses on adolescents aged 12 to 18 who are scheduled for elective surgery for conditions such as scoliosis, kyphosis, spondylolisthesis, pectus surgery, or hip surgery. The study aims to assess how acceptable and practical melatonin use is for these youths and to identify the best ways to measure outcomes related to sleep, pain, and quality of life both shortly after surgery and months later. Participants will be randomly assigned to take either a 3mg fast-dissolve melatonin pill or a placebo pill daily before and after surgery. All participants will receive instructions on good sleep habits. They will wear an actigraphy device, which is like a watch, to monitor sleep patterns before and after surgery. The study includes a treatment phase starting 14 days before surgery and continuing 21 days after, as well as follow-up periods up to 3 months post-surgery. Teens and one of their caregivers will complete brief surveys twice daily for about five weeks and longer online surveys three times over four months. Researchers will monitor treatment adherence, side effects, study acceptability, and retention. They will also assess changes in sleep quality and duration, pain levels, and health-related quality of life. The total study duration involves activities from before surgery through a 3-month follow-up to gather comprehensive data on recovery and well-being.

CONDITIONS

Brief Title

Studying Melatonin and Recovery in Teens

Who Can Participate

Age: 12Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 12 to 18 years
  • Scheduled for elective major musculoskeletal surgery for eligible conditions
  • Resident of California
  • Regular access to internet and a smartphone
  • Able to read and understand English or Spanish
  • Biological parent or legal guardian able to read and understand English or Spanish (for caregiver)
Not Eligible

You will not qualify if you...

  • Taking prescription medication for premorbid insomnia
  • Cognitive impairment or developmental delay
  • Unwilling to undergo a 1-week washout if using other sleep aids before study
  • High risk for sleep-related breathing disorder
  • Severe or systemic chronic medical condition requiring regular treatment
  • Psychiatric admission within the past 30 days
  • Major surgery within the last 3 months or not fully recovered from prior surgery
  • Body mass index at or above the 99th percentile
  • Enrolled in another therapeutic study
  • Any serious underlying medical or psychiatric condition contraindicating participation as judged by the investigator

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 14 days before surgery through 21 days after surgery

Participants take either melatonin or a placebo daily, wear an actigraphy device, and complete brief check-in surveys twice daily and longer online surveys during the treatment period around surgery.

Twice daily check-in surveys and 1 to 3 online surveys during this period

Follow-up

Duration - 7 days at 3-month follow-up

Participants complete additional surveys and treatment adherence assessments approximately 3 months after surgery to monitor recovery and outcomes.

Surveys and assessments during this week

Trial Site Locations

Total: 1 location

1

Lucile Packard Children's Hospital

Palo Alto, California, United States, 94304

Actively Recruiting

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Research Team

J

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

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

Efficacy and safety of melatonin as an anxiolytic and analgesic in the perioperative period: a qualitative systematic review of randomized trials.

Farhanah Yousaf, Edwin Seet, Lashmi Venkatraghavan...

https://pubmed.ncbi.nlm.nih.gov/20823763

The clinical impact of preoperative melatonin on postoperative outcomes in patients undergoing abdominal hysterectomy.

Wolnei Caumo, Fernanda Torres, Nívio L Moreira...

https://pubmed.ncbi.nlm.nih.gov/17959953

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.

Wolnei Caumo, Rosa Levandovski, Maria Paz L Hidalgo

https://pubmed.ncbi.nlm.nih.gov/19010741