NCT06054802

Perioperative Sleep Quality and Postoperative Pain Outcomes

Enrolling by Invitation
Not specifiedAges 10–18Observational
Grant Heydinger
~166 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:eCAP

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pittsburgh Sleep Quality Index
Measured over Baseline
+1 more outcome measured
Surgery
Pain
Sleep
Spinal Fusion
1 sites across 1 states
Ohio1

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

\< 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
  • Pittsburgh Sleep Quality IndexBaseline

    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 eCapDays 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.