Actively Recruiting

Phase Not Applicable
Age: 9Years - 17Years
FEMALE
ID04963751

ERAS in Pediatric and Adolescent Gynecology: How Important is Preoperative Counseling in Patient Outcomes and Does Parent Versus Patient Counseling Impact Success?

Led by University of Colorado, Denver · Updated on 2025-05-06

60

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates the role of participant involvement in pre-operative counseling within Enhanced Recovery After Surgery (ERAS) protocols for pediatric and adolescent gynecology patients aged 9 to 17. It aims to determine if having the patient participate directly in counseling, rather than counseling only the caregiver, can improve post-surgical pain and recovery outcomes. The study will also evaluate adherence to prescribed medications and how quickly participants return to their normal activities, such as school. Participants will be randomly assigned to one of two groups: one where both the patient and their caregiver attend a pre-operative counseling session, and another where only the caregiver attends. This counseling is part of the standard ERAS care protocol, and the study compares these two approaches to find any differences in outcomes. The counseling sessions happen before abdominal surgery managed under the ERAS protocol. During the study, researchers will assess pain levels using numeric pain rating scores on the first and seventh days after surgery. They will also track how many participants have returned to school by seven days post-operation, monitor medication adherence, and record narcotic prescription rates from days one to seven after surgery. The study is randomized without masking and is sponsored by the University of Colorado, Denver. Participation lasts from pre-operative counseling through one week after surgery.

CONDITIONS

Brief Title

ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling

Who Can Participate

Age: 9Years - 17Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 9 to 17 years
  • Undergoing abdominal surgery managed under the ERAS protocol
Not Eligible

You will not qualify if you...

  • Developmental delay with IQ less than 70 as documented in medical records
  • Emergency or non-elective surgical cases
  • Patients who attend clinic appointments independently from their caregiver

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Pre-operative Counseling

Duration - Up to the day of surgery

Participants and/or their caregivers receive pre-operative counseling as part of the Enhanced Recovery After Surgery (ERAS) protocol, either together or caregiver-only depending on group assignment.

1 pre-operative counseling visit

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo abdominal surgery managed under the ERAS protocol followed by immediate post-operative care.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - 1 to 7 days after surgery

Participants are followed for post-surgical pain, medication adherence, return to school, and medication use outcomes.

2 visits (post-op day 1 and day 7)

Trial Site Locations

Total: 1 location

1

Pediatric and Gynecology Clinic at Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

P

Patricia S Huguelet, MD

J

Jaime Laurin, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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