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Designing Animated Movie for Preoperative Period

Primary Purpose

Postoperative Pain, Fear, Surgery

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Educational animated movie group
Documentary movie group
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Postoperative Pain focused on measuring pediatric surgery, preoperative preparation, animation, fear, pain, nursing

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ege University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Educational Animated Movie Group

Documentary Movie Group

Control Group

Arm Description

All of the children's and parents' written and verbal informed consent were obtained before the study. Parents who did not want to participate in the study were assured that this would not have any adverse effect on their child's treatment. In the morning of surgery, the researcher administered the "Child and Family Identification Data Form" to the parents of children who had the following parameters. Later, both the child and the parents were asked to complete the "Children's Fear Scale". Children included in the study groups with randomization watched an educational animated movie through VR Goggles. The educational animated movie lasted around 3-4 minutes each. After watching the movie, children and parents were asked to complete the Children's Fear Scale again. Children, parents, and nurses were asked to grade the pain of the child with Wong-Baker FACES Pain Rating Scale when the children returned to their room and after 1 hour in the postoperative period.

All of the children's and parents' written and verbal informed consent were obtained before the study. Parents who did not want to participate in the study were assured that this would not have any adverse effect on their child's treatment. In the morning of surgery, the researcher administered the "Child and Family Identification Data Form" to the parents of children who had the following parameters. Later, both the child and the parents were asked to complete the "Children's Fear Scale". Children included in the study groups with randomization watched a documentary movie through VR Goggles. The documentary movie lasted around 3-4 minutes each. After watching the movie, children and parents were asked to complete the Children's Fear Scale again. Children, parents, and nurses were asked to grade the pain of the child with Wong-Baker FACES Pain Rating Scale when the children returned to their room and after 1 hour in the postoperative period.

No intervention was made, pain and fear levels were measured using scales only.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 1, 2019
Last Updated
November 25, 2019
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT04176822
Brief Title
Designing Animated Movie for Preoperative Period
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
September 28, 2018 (Actual)
Study Completion Date
March 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Fear, Surgery, Pain, Nursing Caries, Nurse's Role, Clinical Anxiety, Patient, Pediatric
Keywords
pediatric surgery, preoperative preparation, animation, fear, pain, nursing

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
There are 3 independent working groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational Animated Movie Group
Arm Type
Experimental
Arm Description
All of the children's and parents' written and verbal informed consent were obtained before the study. Parents who did not want to participate in the study were assured that this would not have any adverse effect on their child's treatment. In the morning of surgery, the researcher administered the "Child and Family Identification Data Form" to the parents of children who had the following parameters. Later, both the child and the parents were asked to complete the "Children's Fear Scale". Children included in the study groups with randomization watched an educational animated movie through VR Goggles. The educational animated movie lasted around 3-4 minutes each. After watching the movie, children and parents were asked to complete the Children's Fear Scale again. Children, parents, and nurses were asked to grade the pain of the child with Wong-Baker FACES Pain Rating Scale when the children returned to their room and after 1 hour in the postoperative period.
Arm Title
Documentary Movie Group
Arm Type
Experimental
Arm Description
All of the children's and parents' written and verbal informed consent were obtained before the study. Parents who did not want to participate in the study were assured that this would not have any adverse effect on their child's treatment. In the morning of surgery, the researcher administered the "Child and Family Identification Data Form" to the parents of children who had the following parameters. Later, both the child and the parents were asked to complete the "Children's Fear Scale". Children included in the study groups with randomization watched a documentary movie through VR Goggles. The documentary movie lasted around 3-4 minutes each. After watching the movie, children and parents were asked to complete the Children's Fear Scale again. Children, parents, and nurses were asked to grade the pain of the child with Wong-Baker FACES Pain Rating Scale when the children returned to their room and after 1 hour in the postoperative period.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention was made, pain and fear levels were measured using scales only.
Intervention Type
Other
Intervention Name(s)
Educational animated movie group
Intervention Description
Watching educational animation movie which were designed by the researcher before operation for fear and pain.
Intervention Type
Other
Intervention Name(s)
Documentary movie group
Intervention Description
Watching documentary movie about trees before operation for fear and pain.
Primary Outcome Measure Information:
Title
Change of Children's Preoperative Fear
Description
"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.
Time Frame
15 minutes (2 measurements are made-before and after intervention)
Title
Change of Children's Postopeartive Pain
Description
"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.
Time Frame
15 minutes (2 measurements are made-immediately after surgery and 1 hour after surgery) = total 90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ege University
City
İzmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The study will be prepared for publication

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Designing Animated Movie for Preoperative Period

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