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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)
Awards & highlights

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
Select...
I am between 12 and 18 years old.
Select...
I am scheduled for spinal fusion surgery for a specific condition.

Timeline

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

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373
42%
Fatigue
39%
Early Morning Wakening
36%
Daytime drowsiness
11%
Weakness
11%
Dizziness
11%
Nausea
11%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo

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.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,349 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
493 Previous Clinical Trials
1,089,385 Total Patients Enrolled
Jennifer A Rabbitts, M.B.Ch.B.Principal InvestigatorStanford University
~30 spots leftby Mar 2027
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