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

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

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