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Completed

NCT Number: NCT04176822

Designing Animated Movie for Preoperative Period

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.

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Key information

Conditions

Postoperative Pain Clinical Anxiety Fear Neurologic Manifestations Nurse's Role Nursing Caries Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Pediatric Postoperative Complications Signs and Symptoms Surgery

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, 35100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational animated movie group

Other

Watching educational animation movie which were designed by the researcher before operation for fear and pain.

Documentary movie group

Other

Watching documentary movie about trees before operation for fear and pain.

Primary outcomes

  1. Change of Children's Preoperative Fear

    Time frame: 15 minutes (2 measurements are made-before and after intervention)

    "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.

  2. Change of Children's Postopeartive Pain

    Time frame: 15 minutes (2 measurements are made-immediately after surgery and 1 hour after surgery) = total 90 minutes

    "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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 25, 2019
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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