Studying Melatonin and Recovery in Teens

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorStanford University

About this trial

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.

Eligibility criteria

Qualifiers

Age 12-18 years

Participants undergoing elective major musculoskeletal surgery for eligible conditions

California state resident

Regular access to internet and smartphone

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Fast-Dissolve Melatonin Pill
  • Fast-Dissolve Placebo Pill

Treatment groups

45 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Stanford University

Lead sponsor

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

Collaborator