Perioperative Sleep Quality and Postoperative Pain Outcomes

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Grant Heydinger
Study ID
NCT06054802
Status
Enrolling By Invitation

Conditions

  • Pain
  • Sleep
  • Spinal Fusion
  • Surgery

Eligibility Criteria

Sex
ALL
Age
10 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Sep 26, 2023
Start date
Feb 3, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
166 participants (estimated)

Arms

  • Arm: PSF
    Pediatric subjects undergoing posterior spinal fusion (PSF) surgery for idiopathic scoliosis.

Primary Outcome Measure

Pittsburgh Sleep Quality Index [ Time Frame: Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205-

Find similar trials in Columbus, OH

By research site
Nationwide Children's Hospital· Columbus, OH

Related Studies