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

Study Overview
=================
Brief Summary
-----------------
This study aimed to accomplish the following objectives: Develop a family-centered preoperative preparation program. Evaluate the effectiveness of this program in terms of children's preoperative emotional behaviors, postoperative behavior, and posthospital behavior and caregivers' anxiety.

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

Conditions
-----------------
Children Who Underwent Minor Surgery

Intervention / Treatment
-----------------
* Behavioral: preoperative preparation


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard care plus preoperative preparation<br>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<br>* 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.<br>|
| No Intervention: standard care<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

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