Clinical trial NCT06093477: Studying Melatonin and Recovery in Teens
Official title: SurgerySMART: Studying Melatonin and Recovery in Teens
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Juvenile; Scoliosis
Scoliosis Idiopathic
Scoliosis; Adolescence
Scoliosis;Congenital
Kyphosis
Spondylolisthesis
Pectus Surgery
Hip Surgery
Keywords: sleep
pain medicine
pediatric pain medicine
melatonin
pilot feasibility trial
acute pain
chronic pain
CPSP
chronic postsurgical pain
spinal fusion surgery
adolescent
perioperative melatonin
hip surgery
pectus surgery
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2023-10-23
Enrollment: 45
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: The investigators will enroll a total of 45 adolescents ages 12-18 years old who are scheduled to undergo major musculoskeletal surgery and one of their caregivers who meet inclusion and exclusion criteria. Participants will be asked to:

1. Take melatonin or a placebo before and after surgery. All participants will receive sleep hygiene instructions.
2. Wear a watch-like actigraphy device before and after surgery
3. Complete 1-minute check-in surveys twice each day, for about 5 weeks total before and after surgery
4. Complete 10-20-minute online surveys 3 times over 4 months.

Researchers will compare participants randomized to the placebo arm and melatonin arm to see if the trial design and outcomes are both feasible and acceptable to patients and their families.

The main aims are:

Aim 1. To assess the feasibility and acceptability of melatonin for youth undergoing musculoskeletal surgery Aim 2. To determine optimal primary and secondary outcomes (sleep, pain, health-related quality of life) at short-term (during the initial 21 days) and at final follow-up (3 months after surgery). The investigators will examine completion rates, the extent and pattern of missing data, and gather data to provide effect estimates, variances, and 95% confidence intervals.

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

Parents/caregivers

* Biological parent or legal guardian of youth
* Can read and understand English

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\&#39;s participation in the study

Primary outcomes:
measure: Treatment Adherence
timeFrame: Treatment phase of 14 days before surgery through 21 days after surgery (T2), and 7 days at 3-month follow-up (T3)
measure: Study Acceptability
timeFrame: Assessed one time at Dav 21 post-op, and day before surgery (T2)
measure: Enrollment and Retention
timeFrame: 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)
measure: Treatment Side Effects
timeFrame: Assessed one time at Dav 21 post-op, and day before surgery (T2)
Secondary outcomes:
measure: Change in Sleep Quality
timeFrame: Pre-treatment (T1) and one time at 3-month follow-up (T3)
measure: Change in Peri-operative Sleep Quality
timeFrame: Treatment phase of 14 days before surgery through 21 days post-op (T2) and 7 days at 3-month follow-up (T3)
measure: Change in Sleep Duration
timeFrame: Treatment phase of 14 days before surgery through 21 days post-op (T2) and 7 days at 3-month follow-up (T3)
measure: Change in Health-related Quality of Life
timeFrame: Pre-treatment (T1) and one time at 3-month follow-up (T3)
measure: Change in Global Pain Severity
timeFrame: Pre-treatment (T1), one time at Day 21 post-op (T2), and one time at 3-month follow-up (T3)
measure: Change in Pain Intensity and Interference
timeFrame: Baseline pre-surgery assessment (T1), treatment phase of 14 days before surgery through 21 days after surgery (T2), and 7 days at 3-month follow-up (T3)
Other outcomes:
measure: Adverse Events
timeFrame: Treatment phase of 14 days before surgery through 21 days post-op (T2) and 7 days at 3-month follow-up (T3)
measure: Concomitant therapy
timeFrame: Assessed one time at 21 days post-op (T2) and one time at 3-month follow-up (T3)
measure: Pediatric Anxiety
timeFrame: Assessed one time on day before surgery (T2)
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
Study officials:
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