Perioperative Sleep Quality and Postoperative Pain Outcomes

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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Key information

Conditions

Surgery Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Spinal Fusion

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eCAP

Device

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.

Primary outcomes

Pittsburgh Sleep Quality Index

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Grant Heydinger

Other

Registry information

Official study title

The Influence of Perioperative Sleep Quality on Postoperative Pain Outcomes in Pediatric Patients Undergoing Knee Surgery

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Sep 26, 2023
Registry last updated: Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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