Recruiting

Melatonin & Recovery

Sponsor:

Stanford University

Code:

NCT06093477

Conditions

Juvenile; Scoliosis

Scoliosis Idiopathic

Scoliosis; Adolescence

Scoliosis;Congenital

Kyphosis

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

Fast-Dissolve Melatonin Pill

Fast-Dissolve Placebo Pill

Study Details

Brief 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. 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.

Conditions

Juvenile; Scoliosis

Scoliosis Idiopathic

Scoliosis; Adolescence

Scoliosis;Congenital

Kyphosis

Study ID

NCT06093477

Start date

May 30, 2024

Status verified date

Mar, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Fast-Dissolve Melatonin Pill

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

Fast-Dissolve Placebo Pill

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

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) ]
  • Study Acceptability [ Time Frame: Assessed one time at Day 21 post-op, and at 3-month follow-up (T3) ]
  • 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) ]
  • Treatment Side Effects [ Time Frame: Assessed one time at Day 21 post-op, and at 3-month follow-up (T3) ]

Central Contacts and Locations

Central contacts

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

(650) 427-0187surgerysmart@stanford.edu

Locations

Lucile Packard Children's Hospital

Recruiting

Palo Alto, California, United States, 94304

Contacts

Jennifer A Rabbitts, M.D.

650-725-0540rabbitts@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stanford University on 2026-03-18.