Studying Melatonin and Recovery in Teens

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06093477
Status
Recruiting
Apply to this trial

Conditions

  • Hip Surgery
  • Juvenile; Scoliosis
  • Kyphosis
  • Pectus Surgery
  • Scoliosis Idiopathic
  • Scoliosis; Adolescence
  • Scoliosis;Congenital
  • Spondylolisthesis

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Fast-Dissolve Melatonin Pill — DIETARY_SUPPLEMENT
    Participants in this arm will take 3mg of melatonin in fast-dissolve pill form daily during the specified study period.
  • Fast-Dissolve Placebo Pill — OTHER
    Participants in this arm will take 3mg of placebo in fast-dissolve pill form daily during the specified study period.

Study Details

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.

Key Dates

Start date
May 30, 2024
Status verified
Mar 2026
Primary completion
Oct 1, 2026
Completion
Mar 31, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lucile Packard Children's HospitalPalo AltoCalifornia94304
Jennifer A Rabbitts, M.D.
[email protected]
650-725-0540

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By research site
Lucile Packard Children's Hospital· Palo Alto, CA

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