Designing Animated Movie for Preoperative Period

Pain Clinical Trial

Official title:

The Effects of Designing an Educational Animated Movie About Preoperative Preparation on Fear and Post-Operative Pain in Children:A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04176822
• Other study ID #: SYaz
• Secondary ID: Ege
• Status: Completed
• Phase: N/A
• Start date: September 4, 2017
• Est. completion date: March 12, 2019

Study information

• Verified date: November 2019
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Using visual materials is effective in education to decrease children's pre-operative fear and post-operative pain. Children, especially those aged between 6 and 12 years, are interested in technology. This study aims to investigate the effects of watching an educational animated movie in the pre-operative period on fear and postoperative pain in children who are having surgery.

Methods: The study was a prospective randomized controlled trial. This study was conducted between 6- to 12-year-old children in the Pediatric Surgery Clinic of Ege University Medical Faculty Hospital. The current study includes data from 132 children who were chosen doing block randomization. The "Child and Family Identification Data Form", "Children's Fear Scale" and "Wong-Baker FACES Pain Rating Scale" was used in data collection. The patients were divided randomly into three groups as the "Educational Animated Movie Group" (EAMG), "Documentary Movie Group" (DMG) and "Control Group" (CG). The Educational Animated Movie and Documentary Movie were screened using Virtual Reality (VR). Data were collected by the researcher in the pre-operative period. The pre-operative fear of the child was evaluated by the child and the parent, and the post-operative pain of the child was evaluated by the child, parent, and nurse using scales about fear and pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: March 12, 2019
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• First surgery

• Daily surgery and uncomplicated surgery

• Agree to participate in the study

• Speaking Turkish

Exclusion Criteria:

• Refusal to participate in the study

• A genetic/congenital disease

• A chronic disease

• Second or more surgery

• Not speaking Turkish

Related Conditions & MeSH terms

• Clinical Anxiety
• Fear
• Nurse's Role
• Nursing Caries
• Pain
• Pain, Postoperative
• Patient
• Pediatric
• Postoperative Pain
• Surgery

Intervention

Other:
• Educational animated movie group
Watching educational animation movie which were designed by the researcher before operation for fear and pain.
• Documentary movie group
Watching documentary movie about trees before operation for fear and pain.

Locations

Country	Name	City	State
Turkey	Ege University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Children's Preoperative Fear	"Children's Fear Scale" (CFS) was developed and adapted by McMurtry et al. (2011).; This scale includes 5 different facial expressions. This scale, graded between 0 and 4, ("0" is none fear, "4" is maximum fear) is a reliable and valid measurement tool for assessing fear.; It includes measuring and evaluating preoperative fears of children.	15 minutes (2 measurements are made-before and after intervention)
Primary	Change of Children's Postopeartive Pain	"Wong-Baker FACES Pain Rating Scale" This scale includes six different facial expressions and is scored between 0 and 10 ("0" is none pain, "10" is maximum pain). It is a reliable and valid measurement tool for acute pain assessment, and it does not require words or numeric value.; It includes measuring and evaluating postoperative pains of children.	15 minutes (2 measurements are made-immediately after surgery and 1 hour after surgery) = total 90 minutes