SurgerySMART: Studying Melatonin and Recovery in Teens

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: f
View:

⁃ 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

⁃ Parents/caregivers

• Biological parent or legal guardian of youth

• Can read and understand English

Locations
United States
California
Lucile Packard Children's Hospital
RECRUITING
Palo Alto
Contact Information
Primary
Jennifer A Rabbitts, M.B.Ch.B.
surgerysmart@stanford.edu
(650) 427-0187
Time Frame
Start Date: 2024-05-30
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 45
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Stanford University
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This content was sourced from clinicaltrials.gov