The Effectiveness of Preoperative Preparation for Improving Perioperative Outcomes in Children and Caregivers

October 17, 2017 updated by: Chiayi Christian Hospital

This study aimed to accomplish the following objectives:

  1. Develop a family-centered preoperative preparation program.
  2. Evaluate the effectiveness of this program in terms of children's preoperative emotional behaviors, postoperative behavior, and posthospital behavior and caregivers' anxiety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 3-12 years, received general anesthesia, and admitted for elective outpatient ear, nose and throat, orthopedic, ophthalmology or general surgery.

Exclusion Criteria:

  • Children with severe development delay or chronic illness were excluded. Caregivers were excluded if they could not accompany their child to the hospital on the day of the surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: standard care
Experimental: standard care plus preoperative preparation
experimental group received standard care plus preoperative preparation, which included a tour, a cartoon video depicting a boy's surgical journey and familiarization with medical equipment.
Behavioral: preoperative preparation
Participants in the experimental group received standard care plus our newly developed, multicomponent family-centered preoperative preparation program. This program included the following: (1) a tour of the preoperative area and recovery room; (2) a 4-min cartoon video entitled 'I am not afraid of surgery,' which was tailored to the child; this video included 29 scenes that depicted a boy's surgical journey with a particular emphasis on strategies for addressing postoperative pain; and (3) familiarization with medical equipment such as name badges, disposable hair caps, anesthetic masks, EKG leads, and pulse oximeters, which were placed on a doll, to help children understand the surgical instruments and promote better cooperation at the time of anesthesia induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Emotional Behaviors: The Children's Emotional Manifestation Scale
Time Frame: before the operative day
to assess children's emotional behaviors during stressful medical situations
before the operative day
Children's Emotional Behaviors: The Children's Emotional Manifestation Scale
Time Frame: the morning in the day of surgery
to assess children's emotional behaviors during stressful medical situations
the morning in the day of surgery
Children's Emotional Behaviors: The Children's Emotional Manifestation Scale
Time Frame: at induction of anesthesia
to assess children's emotional behaviors during stressful medical situations
at induction of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiayi Christian Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2014

Primary Completion (Actual)

May 15, 2016

Study Completion (Actual)

May 15, 2016

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 17, 2017

First Posted (Actual)

October 19, 2017

Study Record Updates

Last Update Posted (Actual)

October 19, 2017

Last Update Submitted That Met QC Criteria

October 17, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 103013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Children Who Underwent Minor Surgery

Clinical Trials on preoperative preparation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe