Perioperative Sleep Quality and Postoperative Pain Outcomes

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06054802
• Other study ID #: STUDY00003629
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: August 2025

Study information

• Verified date: February 2024
• Source: Nationwide Children's Hospital
• Contact: Julie Rice-Weimer, BSN
• Phone: 6143553142
• Email: julie.rice-weimer[@]nationwidechildrens.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 166
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• able to read, understand, and speak English
• are undergoing ACL repair or reconstruction
• 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

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries
• Pain
• Pain, Postoperative
• Sleep
• Surgery

Intervention

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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Grant Heydinger

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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