SurgerySMART: Studying Melatonin and Recovery in Teens

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06093477

Collaborator

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

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this feasibility clinical trial is to learn if melatonin can help teens having spinal fusion 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 spinal fusion surgery, as well as determine optimal measured outcomes (sleep, pain, health-related quality of life) at short- and long-term follow-up.

Condition or Disease	Intervention/Treatment	Phase
Juvenile; Scoliosis Scoliosis Idiopathic Scoliosis; Adolescence Scoliosis;Congenital Kyphosis Spondylolisthesis	Dietary Supplement: Melatonin Other: Syrup	N/A

Detailed Description

The investigators will enroll a total of 40 adolescents ages 12-18 years old who are scheduled to undergo spinal fusion and one of their caregivers who meet inclusion and exclusion criteria. Participants will be asked to:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

SurgerySMART: Studying Melatonin and Recovery in Teens

Anticipated Study Start Date :

Jul 1, 2024

Anticipated Primary Completion Date :

Mar 1, 2027

Anticipated Study Completion Date :

Jun 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 5mg Liquid Placebo Participants will take a placebo of 5mg syrup, complete surveys, and wear an actigraphy device during the specified study period.	Other: Syrup Participants in this arm will take 5mg of liquid syrup daily during the specified study period.
Experimental: 5mg Liquid Melatonin Participants will take 5mg of melatonin in liquid form, complete surveys, and wear an actigraphy device during the specified study period.	Dietary Supplement: Melatonin Participants in this arm will take 5mg of liquid melatonin daily during the specified study period.

Arm

Intervention/Treatment

Placebo Comparator: 5mg Liquid Placebo

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

Other: Syrup

Participants in this arm will take 5mg of liquid syrup daily during the specified study period.

Experimental: 5mg Liquid Melatonin

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

Dietary Supplement: Melatonin

Participants in this arm will take 5mg of liquid melatonin daily during the specified study period.

Outcome Measures

Primary Outcome Measures

Treatment Adherence [Treatment phase of 14 days before surgery through 21 days after surgery (T2), and 7 days at 3-month follow-up (T3)]
Youth will self-report daily medication administration on the evening diary, including the study drug as well as opioid and non-opioid analgesic medications. Medication administration will also be extracted from the EMR during hospitalization. Adherence will be measured as the percentages of doses taken.
Study Acceptability [Assessed one time at Dav 21 post-op, and day before surgery (T2)]
Youth and parent will complete ratings of treatment acceptability using a 5-point scale, ranging from 1 (Strong Dislike or Strongly Disagree) to 5 (Strongly Like or Strongly Agree). A higher score indicates greater study acceptability.
Enrollment and Retention [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)]
Research coordinators will record participant status at each stage including participants approached, assessed for eligibility, invited, consented, randomly assigned, and who received the intended treatment, and completed assessment timepoints, and will collect reasons for declining and dropout. Feasibility metrics will include enrollment rate and attrition rate.
Treatment Side Effects [Assessed one time at Dav 21 post-op, and day before surgery (T2)]
Youth participants will be asked an open-ended question about side effects they may have experienced from the study drug. The rate of side effects of treatment will be self-reported by participants and extracted from EMR during hospitalization.

Secondary Outcome Measures

Change in Sleep Quality [Pre-treatment (T1) and one time at 3-month follow-up (T3)]
Youth will complete the Adolescent Sleep Wake Scale (ASWS), a 10-item measure of sleep quality over the past month rated on a 6-point Likert scale ranging from "Always" to "Never". The measure assesses five behavioral dimensions of sleep quality: (1) going to bed, (2) falling asleep/latency, (3) maintaining sleep, (4) re-initiating sleep, and (5) returning to wakefulness, and yields a total sleep quality score.
Change in Peri-operative Sleep Quality [Treatment phase of 14 days before surgery through 21 days post-op (T2) and 7 days at 3-month follow-up (T3)]
Youth will complete once daily online diaries assessing daily sleep quality in the morning. Sleep quality will be rated on an 11-point scale ranging from 0 (Extremely poor sleep) to 10 (Extremely good sleep). A higher score indicates higher quality sleep.
Change in Sleep Duration [Treatment phase of 14 days before surgery through 21 days post-op (T2) and 7 days at 3-month follow-up (T3)]
Youth will wear an actigraphy monitor to measure sleep duration. Youth will also report on sleep and wake times on the online morning diary, which will be used to assist with actigraphy scoring. Actigraphic sleep variables will include: minutes of estimated sleep, and sleep efficiency.
Change in Health-related Quality of Life [Pre-treatment (T1) and one time at 3-month follow-up (T3)]
Youth will complete the Pediatric Quality of Life Inventory (PedsQL), a 15-item measure that assesses self-reported physical, social, and emotional health-related qualify of life over the prior 7 days. The measure yields Physical Health, Psychosocial Health, and Total Health summary scores. The PedsQL is widely used and demonstrates good reliability for both the parent and child self-report measures. Scale scores range from 0 to 100. Higher scores indicate fewer difficulties (better) health-related quality of life.
Change in Global Pain Severity [Pre-treatment (T1), one time at Day 21 post-op (T2), and one time at 3-month follow-up (T3)]
Youth will complete the Global Impression of Severity, a single item measure that assesses self-reported patient global impression of pain severity in the preceding 7 days. Response options range from 0 (none) to 3 (severe) with higher scores indicating higher pain severity.
Change in Pain Intensity and Interference [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)]
Youth will complete the Brief Pain Inventory (BPI), which assesses worst, least, average, and current pain intensity (4 items) and pain interference on daily functions (7 items) in the prior 7 days, with response options indicated on 11-point NRS. Items are averaged to yield scale scores, ranging from 0 to 10, with higher scores indicating greater pain intensity or interference.

Other Outcome Measures

Adverse Events [Treatment phase of 14 days before surgery through 21 days post-op (T2) and 7 days at 3-month follow-up (T3)]
Youth and parents will be asked open-ended questions about adverse events.
Concomitant therapy [Assessed one time at 21 days post-op (T2) and one time at 3-month follow-up (T3)]
Youth and parents will be asked open-ended questions about concomitant therapies the patient may have taken (use of sleep aids).
Pediatric Anxiety [Pre-treatment (T1) and assessed one time on day before surgery (T2)]
Youth will complete the PROMIS Anxiety Short Form 8a, which assesses the pure domain of anxiety in children and adolescents (8 items) in the prior 7 days, with response options indicated on a 5-point scale. Higher scores indicate greater severity of anxiety. Response options range from 1 (Never) to 5 (Almost Always). Raw scores for anxiety and depression are obtained by summing the corresponding items' response values, and range from 8 to 40 with higher scores indicating higher distress.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients/youth:

Age 12-18 years
Participants undergoing elective spinal fusion 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