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Melatonin for Post-Surgery Recovery in Teens with Scoliosis (SurgerySMART Trial)

N/A

Recruiting

Led By Jennifer A Rabbitts, M.B.Ch.B.

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients/youth: Age 12-18 years

Participants undergoing elective spinal fusion surgery for eligible conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment phase of 14 days before surgery through 21 days post-op (t2) and 7 days at 3-month follow-up (t3)

Summary

This trial will assess if melatonin can help teens having spinal fusion surgery by improving their sleep, pain and quality of life.

Who is the study for?

This trial is for English-speaking teens aged 12-18 in California who are having spinal fusion surgery. They must have internet access and a smartphone, and their parents or guardians need to be involved. Teens with recent psychiatric admissions, very high BMI, untreated major medical conditions, or those on certain medications can't participate.

What is being tested?

The study is testing if melatonin syrup helps teens recover after spinal fusion surgery by improving sleep quality. It will check how well the treatment works and whether it's something patients are okay with using both short-term and long-term.

What are the potential side effects?

Melatonin may cause drowsiness, headache, dizziness or nausea. However, since it's generally considered safe as a dietary supplement when used correctly, serious side effects are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 18 years old.

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I am scheduled for spinal fusion surgery for a specific condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-treatment (t1), treatment phase of 14 days before surgery through 21 days after surgery (t2), and 7 days at 3-month follow-up (t3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-treatment (t1), treatment phase of 14 days before surgery through 21 days after surgery (t2), and 7 days at 3-month follow-up (t3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment (t1), treatment phase of 14 days before surgery through 21 days after surgery (t2), and 7 days at 3-month follow-up (t3) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Enrollment and Retention

Study Acceptability

Treatment Adherence

+1 more

Secondary study objectives

Change in Global Pain Severity

Change in Health-related Quality of Life

Change in Pain Intensity and Interference

+3 more

Other study objectives

Adverse Events

Concomitant therapy

Pediatric Anxiety

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 3mg fast-dissolve pill (containing melatonin)Experimental Treatment1 Intervention

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.

Group II: 3mg fast-dissolve pillPlacebo Group1 Intervention

Participants will take a placebo of 3mg fast-dissolve pill (without melatonin), complete surveys, and wear an actigraphy device during the specified study period.

0 / 2Eligibility criteria met