Studying Melatonin and Recovery in Teens

Description

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, Spondylolisthesis, Pectus Surgery, Hip Surgery

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Study Overview

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Study Details

Study overview

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.

SurgerySMART: Studying Melatonin and Recovery in Teens

Studying Melatonin and Recovery in Teens

Condition
Juvenile; Scoliosis
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Lucile Packard Children's Hospital, Palo Alto, California, United States, 94304

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Biological parent or legal guardian of youth
  • * Can read and understand English
  • * 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

Ages Eligible for Study

12 Years to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Study Record Dates

2028-06