Juvenile; ScoliosisScoliosis IdiopathicScoliosis; AdolescenceScoliosis;CongenitalKyphosisSpondylolisthesisPectus SurgeryHip Surgery
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At a Glance
Age
12 – 18
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
45 (estimated)
Sponsor
Stanford University · Other
Who this trial is looking for
This trial is looking for teenagers aged 12-18 who are having major musculoskeletal surgery. Participants will take melatonin to see if it helps them sleep better during recovery.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 12 and 18 years old.
I am a California resident.
I have regular access to the internet and a smartphone.
I can read and understand English or Spanish.
I will have major musculoskeletal surgery.
You may not be able to join if
I have taken prescription medication for sleep issues before the study.
I have a cognitive impairment or developmental delay.
I have not agreed to a 1-week break from other sleep aids before starting.
I am at high risk for sleep-related breathing problems.
I have a severe chronic medical condition.
I was admitted for psychiatric care in the last 30 days.
I had major surgery in the last 3 months or have not fully recovered.
My BMI is at or above the 99th percentile.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 determ…
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.
Trial Locations
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Eligibility Criteria
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 pare…
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
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