Perioperative Sleep Quality and Postoperative Pain Outcomes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ACL surgery Pediatric subjects undergoing surgery for ACL repair. |
Device: eCAP
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.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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able to read, understand, and speak English
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are undergoing ACL repair or reconstruction
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have availability of a mobile device/computer to receive text messages
Exclusion Criteria:
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< 10 or > 18 years of age
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have a history of sleep-disordered breathing including sleep apnea
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have a history of chronic pain or current opioid use
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have a history of developmental delay that would preclude study participation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nationwide Children's Hospital | Columbus | Ohio | United States | 43205 |
Sponsors and Collaborators
- Grant Heydinger
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00003629