Studying Melatonin and Recovery in Teens

Treatment Adherence

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

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.

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.

Adverse Events

Youth and parents will be asked questions about adverse events.

Concomitant therapy

Youth and parents will be asked open-ended questions about concomitant therapies the patient may have taken (use of sleep aids).

Pediatric Anxiety

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.