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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSF | Pediatric subjects undergoing posterior spinal fusion (PSF) surgery for idiopathic scoliosis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eCAP | Device | eCapâ„¢ has the look and feel of a regular prescription bottle and records real-time adherence data, tracking each opening with the date and time. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index | 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. | Baseline |
| Difference in opioid consumption between self-report and eCap | 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. | Days 1-14 post-op |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric/adolescent patients undergoing anterior cruciate ligament (ACL) repair or reconstruction at Nationwide Children's Hospital.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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