Perioperative Sleep Quality and Postoperative Pain Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-03

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Surgery ACL Injury Pain Sleep

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ACL surgery

Pediatric subjects undergoing surgery for ACL repair.

eCAP

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No