Perioperative Sleep Quality and Postoperative Pain Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: eCAP.
- Who it may be relevant to
- Registry conditions: Surgery, Pain, Sleep, Spinal Fusion. Basic parameters: 10 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Influence of Perioperative Sleep Quality on Postoperative Pain Outcomes in Pediatric Patients Undergoing Knee Surgery
Overview
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.
Interventions
- 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.
Primary outcome measures
- Pittsburgh Sleep Quality Index [Time frame: Baseline]
- Difference in opioid consumption between self-report and eCap [Time frame: Days 1-14 post-op]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Nationwide Children's Hospital — Columbus
Identifiers
NCT: NCT06054802 · STUDY00003629