ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT04963751
Status
Recruiting
Apply to this trial

Conditions

  • Enhanced Recovery After Surgery
  • Gynecologic Disease

Eligibility Criteria

Sex
FEMALE
Age
9 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Enhanced Recovery After Surgery (ERAS) Counseling to Patients — OTHER
    In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the patient's caregiver rather than directly to the patient. It is possible that direct patient involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes.
  • Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver — OTHER
    In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the patient's caregiver rather than directly to the patient. It is possible that direct patient involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes.

Study Details

The Investigator propose a randomized trial that will assess whether participant involvement in pre-operative counseling for ERAS improves post-surgical pain scores. The Investigator will also assess participant compliance to ERAS-prescribed medications, and functionality (return to school). Each participant who is enrolled in the study will be assigned to 1) pre-operative counseling with participant's caregiver or 2) caregiver-only counseling.

Key Dates

Start date
Sep 8, 2022
Status verified
May 2025
Primary completion
Jan 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: pre-operative counseling with their caregiver
    Patients will be asked to attend a standard-of-care pre-operative teaching session with their parent.
  • Placebo Comparator: caregiver-only counseling.
    Parents-only will attend a standard-of-care pre-operative teaching session.

Primary Outcome Measure

Numeric Pain rating scores at post-op days 1 and 7 [ Time Frame: 1-7 days after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pediatric and Gynecology Clinic at Children's Hospital ColoradoAuroraColorado80045
Patricia Huguelet, MD
[email protected]
720-777-2238

Find similar trials in Aurora, CO

By research site
Pediatric and Gynecology Clinic at Children's Hospital Colorado· Aurora, CO

Related Studies