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

N/A

Waitlist Available

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

SurgerySMART Trial 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.Check my eligibility

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.See study design

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.

SurgerySMART Trial 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.

SurgerySMART Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Enrollment and Retention

Study Acceptability

Treatment Adherence

+1 more

Secondary outcome measures

Change in Global Pain Severity

Change in Health-related Quality of Life

Change in Pain Intensity and Interference

+3 more

Other outcome measures

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%

Study treatment Arm

Melatonin

Placebo

SurgerySMART Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 5mg Liquid MelatoninExperimental Treatment1 Intervention

Participants will take 5mg of melatonin in liquid form, complete surveys, and wear an actigraphy device during the specified study period.

Group II: 5mg Liquid PlaceboPlacebo Group1 Intervention

Participants will take a placebo of 5mg syrup, complete surveys, and wear an actigraphy device during the specified study period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melatonin

2014

Completed Phase 4

~1150

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,386 Previous Clinical Trials

17,333,968 Total Patients Enrolled

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH

483 Previous Clinical Trials

1,086,900 Total Patients Enrolled

1 Trials studying Spondylolisthesis

304 Patients Enrolled for Spondylolisthesis

Jennifer A Rabbitts, M.B.Ch.B.Principal InvestigatorStanford University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this trial limited to those who are 85 years or younger?

"According to the clinical trial parameters, eligible participants must be between 12 and 18 years old. In total, there are 83 studies available for those below the age of majority while 46 trials focus on seniors over 65."

Answered by AI

Are there still chances to participate in this medical trial?

"This trial is no longer recruiting patients and was last edited on October 16th 2023, according to the information published on clinicaltrials.gov. Fortunately, there are 122 other trials taking part in patient recruitment at this moment."

Answered by AI

What is the objective of this research endeavor?

"The primary objective of this clinical experiment, monitored over a span of two weeks pre-surgery to three weeks post-surgery and seven days after the 3 month follow up is assessing acceptability. Secondary aims encompass gauging change in perioperative sleep quality via an 11-point scale ranging from 0 (Extremely poor) to 10 (Excellent), pinpointing alteration in sleep duration with actigraphy monitoring, plus appraising health related quality of life using the Pediatric Quality of Life Inventory's Physical Health, Psychosocial Health and Total Health summative scores."

Answered by AI

Are there any restrictions on who can participate in this experiment?

"Eligibility for this clinical trial requires that patients have spondylolisthesis and are between the ages of 12 to 18. So far, approximately 40 individuals meet these criteria and can participate in the study."

Answered by AI

Recent research and studies

The Journal of PainJournal

Presurgical Psychosocial Predictors of Acute Postsurgical Pain and Quality of Life in Children Undergoing Major Surgery

Rabbitts, Jennifer A., Cornelius B. Groenewald, Gabrielle G. Tai, and Tonya M. Palermo. 2015. “Presurgical Psychosocial Predictors of Acute Postsurgical Pain and Quality of Life in Children Undergoing Major Surgery”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2014.11.015.

PainJournal

Trajectories of Postsurgical Pain in Children

Rabbitts, Jennifer A., Chuan Zhou, Cornelius B. Groenewald, Lindsay Durkin, and Tonya M. Palermo. 2015. “Trajectories of Postsurgical Pain in Children”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/j.pain.0000000000000281.

The Journal of PainJournal

Pain and Health-related Quality of Life After Pediatric Inpatient Surgery

Rabbitts, Jennifer A., Tonya M. Palermo, Chuan Zhou, and Rita Mangione-Smith. 2015. “Pain and Health-related Quality of Life After Pediatric Inpatient Surgery”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2015.09.005.

The Journal of PainJournal