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Studying Melatonin and Recovery in Teens (SurgerySMART)

Primary Purpose

Juvenile; Scoliosis, Scoliosis Idiopathic, Scoliosis; Adolescence

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Syrup
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Juvenile; Scoliosis focused on measuring sleep, pain medicine, pediatric pain medicine, melatonin, pilot feasibility trial, acute pain, chronic pain, CPSP, chronic postsurgical pain, spinal fusion surgery, adolescent, perioperative melatonin

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Lucile Packard Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

5mg Liquid Placebo

5mg Liquid Melatonin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Treatment Adherence
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
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
October 9, 2023
Last Updated
October 16, 2023
Sponsor
Stanford University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT06093477
Brief Title
Studying Melatonin and Recovery in Teens
Acronym
SurgerySMART
Official Title
SurgerySMART: Studying Melatonin and Recovery in Teens
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2024 (Anticipated)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile; Scoliosis, Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis;Congenital, Kyphosis, Spondylolisthesis
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5mg Liquid Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will take a placebo of 5mg syrup, complete surveys, and wear an actigraphy device during the specified study period.
Arm Title
5mg Liquid Melatonin
Arm Type
Experimental
Arm Description
Participants will take 5mg of melatonin in liquid form, complete surveys, and wear an actigraphy device during the specified study period.
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin
Intervention Description
Participants in this arm will take 5mg of liquid melatonin daily during the specified study period.
Intervention Type
Other
Intervention Name(s)
Syrup
Intervention Description
Participants in this arm will take 5mg of liquid syrup daily during the specified study period.
Primary Outcome Measure Information:
Title
Treatment Adherence
Description
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.
Time Frame
Treatment phase of 14 days before surgery through 21 days after surgery (T2), and 7 days at 3-month follow-up (T3)
Title
Study Acceptability
Description
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.
Time Frame
Assessed one time at Dav 21 post-op, and day before surgery (T2)
Title
Enrollment and Retention
Description
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.
Time Frame
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)
Title
Treatment Side Effects
Description
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.
Time Frame
Assessed one time at Dav 21 post-op, and day before surgery (T2)
Secondary Outcome Measure Information:
Title
Change in Sleep Quality
Description
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.
Time Frame
Pre-treatment (T1) and one time at 3-month follow-up (T3)
Title
Change in Peri-operative Sleep Quality
Description
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.
Time Frame
Treatment phase of 14 days before surgery through 21 days post-op (T2) and 7 days at 3-month follow-up (T3)
Title
Change in Sleep Duration
Description
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.
Time Frame
Treatment phase of 14 days before surgery through 21 days post-op (T2) and 7 days at 3-month follow-up (T3)
Title
Change in Health-related Quality of Life
Description
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.
Time Frame
Pre-treatment (T1) and one time at 3-month follow-up (T3)
Title
Change in Global Pain Severity
Description
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.
Time Frame
Pre-treatment (T1), one time at Day 21 post-op (T2), and one time at 3-month follow-up (T3)
Title
Change in Pain Intensity and Interference
Description
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.
Time Frame
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 Pre-specified Outcome Measures:
Title
Adverse Events
Description
Youth and parents will be asked open-ended questions about adverse events.
Time Frame
Treatment phase of 14 days before surgery through 21 days post-op (T2) and 7 days at 3-month follow-up (T3)
Title
Concomitant therapy
Description
Youth and parents will be asked open-ended questions about concomitant therapies the patient may have taken (use of sleep aids).
Time Frame
Assessed one time at 21 days post-op (T2) and one time at 3-month follow-up (T3)
Title
Pediatric Anxiety
Description
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.
Time Frame
Pre-treatment (T1) and assessed one time on day before surgery (T2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Team
Phone
650-725-0540
Email
rabbittslab@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Vienna Y Wang, B.A.
Phone
650-498-8196
Email
vwang115@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer A Rabbitts, M.B.Ch.B.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucile Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer A Rabbitts, M.D.
Phone
650-725-0540
Email
rabbitts@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study team will follow the NIH (NATIONAL INSTITUTES OF HEALTH) Policy on the Dissemination of NIH-Funded Clinical Trial Information (Clinical Trials Policy) by producing a sharable database as soon as possible upon publication of the primary analyses. To protect participants' privacy, the dataset available for sharing will be deidentified at the aggregate level of the underlying primary data (demographic data, summary scores on survey measures, summary of actigraphy data) according to definitions provided in the Health Insurance Portability and Accountability Act (HIPAA). Namely, all identifiers specified in HIPAA will be re-coded in a manner that will make it impossible to deduce or impute the specific identity of any participant. The database will not contain any institutional identifiers. Data elements that are considered unreliable will be deleted to foster ease of data reuse. Informed consent forms will reflect plans for de-identification and aggregate sharing.
IPD Sharing Time Frame
Shared data generated from this project will be available as soon as possible, and no later than the time of publication of the analyses examining the study's primary aims. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.
IPD Sharing Access Criteria
Data will be made available in a data repository which allows research teams to restrict access to the data to qualified investigators with an appropriate research question and approved data use agreement. The data use agreement limits subsequent use to the terms of the approved request and requires that users maintain data security and refrain from any attempts to re-identify research participants or engage in any unauthorized use of the data. PI Dr. Jennifer Rabbitts, ORCID: https://orcid.org/0000-0003-4800-1080, will oversee day-to-day data management activities and data sharing. Dr. Rabbitts will also oversee broader issues of DMS (Data Management and Sharing) Plan compliance oversight reporting which will include maintaining databases, as part of general data stewardship, reporting, and compliance processes.
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Studying Melatonin and Recovery in Teens

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