Pain, Sleep, Spinal Fusion, Surgery
Conditions
Brief summary
This is a prospective, observational cohort study that will examine how sleep quality impacts postoperative pain and opioid consumption for pediatric patients. The investigators will administer a questionnaire preoperatively to determine which patients have poor or good sleep quality. They will then compare postoperative pain and opioid use between groups for two weeks following surgery. For a secondary aim, investigators will use electronic medication vials (eCAP) to monitor participants' medication use at home and compare to self-reporting.
Interventions
DEVICEeCAP
eCap™ has the look and feel of a regular prescription bottle and records real-time adherence data, tracking each opening with the date and time.
Sponsors
Grant Heydinger
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* able to read, understand, and speak English * are undergoing posterior spinal fusion surgery * have availability of a mobile device/computer to receive text messages
Exclusion criteria
* \< 10 or \> 18 years of age * have a history of sleep-disordered breathing including sleep apnea * have a history of chronic pain or current opioid use * have a history of developmental delay that would preclude study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index | Baseline | Pittsburgh Sleep Quality Index (PSQI) is a validated, self-report questionnaire that assesses sleep quality over a one-month period that takes five to ten minutes to complete. It offers seven component scores (e.g., subjective sleep quality, latency, duration, and efficiency) as well as a composite score that measures overall sleep quality. A total score greater than five yields a sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p \<0.001) in distinguishing good from poor sleepers. |
| Difference in opioid consumption between self-report and eCap | Days 1-14 post-op | The eCAP Electronic Content Monitor (ECM) is a smart pill bottle used to monitor and improve medication adherence. When opened, an event is recorded, and the data is securely stored. The eCAP device timestamps medication usage and provides a visualization demonstrating how patients are taking medications, providing robust analytics. Subjects will also record each time they take an opioid pain medicine on a daily diary. |
Countries
United States
Outcome results
None listed