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

Children Who Underwent Minor Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03314220
• Other study ID #: 103013
• Status: Completed
• Phase: N/A
• First received: October 2, 2017
• Last updated: October 17, 2017
• Start date: May 15, 2014
• Est. completion date: May 15, 2016

Study information

• Verified date: October 2017
• Source: Chiayi Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 15, 2016
• Est. primary completion date: May 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children Who Underwent Minor Surgery

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chiayi Christian Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Emotional Behaviors: The Children's Emotional Manifestation Scale	to assess children's emotional behaviors during stressful medical situations	before the operative day
Primary	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
Primary	Children's Emotional Behaviors: The Children's Emotional Manifestation Scale	to assess children's emotional behaviors during stressful medical situations	at induction of anesthesia