SurgerySMART: Studying Melatonin and Recovery in Teens
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Enrollment and Retention
研究概览
简要总结
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.
详细描述
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:
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 or Spanish
- •Parents/caregivers
- •Biological parent or legal guardian of youth
- •Can read and understand English or Spanish
排除标准
- •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
研究组 & 干预措施
3mg fast-dissolve pill
Participants will take a placebo of 3mg fast-dissolve pill (without melatonin), complete surveys, and wear an actigraphy device during the specified study period.
干预措施: Fast-Dissolve Placebo Pill (Other)
3mg fast-dissolve pill (containing melatonin)
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.
干预措施: Fast-Dissolve Melatonin Pill (Dietary Supplement)
结局指标
主要结局
Enrollment and Retention
时间窗: 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 Adherence
时间窗: 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 morning and evening diaries, 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
时间窗: Assessed one time at Day 21 post-op, and at 3-month follow-up (T3)
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.
Treatment Side Effects
时间窗: Assessed one time at Day 21 post-op, and at 3-month follow-up (T3)
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.
次要结局
- Change in Sleep Quality(Pre-treatment (T1) and one time at 3-month follow-up (T3))
- 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))
- 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))
- Change in Health-related Quality of Life(Pre-treatment (T1) and one time at 3-month follow-up (T3))
- 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))
- 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))
研究者
Jennifer Rabbitts
Professor, Department of Anesthesiology, Perioperative, and Pain Medicine
Stanford University