Studying Melatonin and Recovery in Teens (SurgerySMART)

Stanford University

Status: Enrolling

Conditions: Hip Surgery; Spondylolisthesis; Juvenile; Scoliosis; Scoliosis; Adolescence; Scoliosis;Congenital; Scoliosis Idiopathic; Pectus Surgery; Kyphosis

Treatments: Dietary Supplement: Fast-Dissolve Melatonin Pill; Other: Fast-Dissolve Placebo Pill

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06093477

7K24AR080786-02 (U.S. NIH Grant/Contract)

IRB-71745

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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's participation in the study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups, including a placebo group

3mg fast-dissolve pill

Placebo Comparator group

Description:

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

Treatment:

Other: Fast-Dissolve Placebo Pill

3mg fast-dissolve pill (containing melatonin)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fast-Dissolve Melatonin Pill