Perioperative Sleep Quality and Postoperative Pain Outcomes

March 31, 2026 updated by: Grant Heydinger

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

166

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric/adolescent patients undergoing anterior cruciate ligament (ACL) repair or reconstruction at Nationwide Children's Hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PSF
Pediatric subjects undergoing posterior spinal fusion (PSF) surgery for idiopathic scoliosis.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Days 1-14 post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grant Heydinger

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003629

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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