Cartoons and Musical-moving Toys in Invasive Procedure Applications Reduce Pain and Fear Levels of Children

March 29, 2022 updated by: ARZU SARIALİOĞLU, Ataturk University

Cartoons and Musical-moving Toys in Invasive Procedure Applications Reduce Pain and Fear Levels of Children: A Randomized Controlled Study

Aim: The aim of this study is to determine the effect of the cartoon and musical-moving toy watched in the invasive procedure application on the pain and fear level of children.

Material and Method: The research was carried out as a randomized controlled experiment in Atatürk University Health Research and Application Center Pediatric Emergency Service between March 2021 and February 2022. The population of the study consisted of children between the ages of 3 and 6 who came for treatment at the specified hospital. The sample of the research; 40 cartoons, 40 musical-moving toys, 40 control group, totally 120 children who applied to the pediatric emergency service between June 2021 and January 2022 and met the research criteria and volunteered to participate in the research. Data collection tools were collected through face-to-face interviews with "Survey Form", "Wong-Baker Faces Pain Rating Scale (WBS)" and "Child Fear Scale (CFS)". In the research, "cartoon" and "musical-moving toy" were used as intervention tools.

Study Overview

Status

Completed

Conditions

Detailed Description

Aim: The aim of this study is to determine the effect of the cartoon and musical-moving toy watched in the invasive procedure application on the pain and fear level of children.

Material and Method: The research was carried out as a randomized controlled experiment in Atatürk University Health Research and Application Center Pediatric Emergency Service between March 2021 and February 2022. There is one intervention room in the Pediatric Emergency Service. There are blood collection stretcher, vascular access-bleeding materials (intraket, cotton, 70% alcohol, tourniquet, plaster, injector, blood tubes, etc.) in this room.The population of the study consisted of children between the ages of 3 and 6 who came for treatment at the specified hospital. In order to ensure randomization, the children who met the criteria were included in the control group in the first week, the children in the second week were included in the cartoon group, and the children in the third week were included in the musical-moving toy group, and this cycle was continued until the end of the study and randomization was achieved.The sample of the research; 40 cartoons, 40 musical-moving toys, 40 control group, totally 120 children who applied to the pediatric emergency service between June 2021 and January 2022 and met the research criteria and volunteered to participate in the research. Children from 2 experimental and 2 control groups who did not want to participate in the study were excluded from the study. Prior power analysis was performed to determine the adequacy of the sample size of the study. In the power analysis, it was determined that the study was at the significance level of 0.05, at the 95% confidence interval, and the effect size was 0.551 and the power was 0.99. Data collection tools were collected through face-to-face interviews with "Survey Form", "Wong-Baker Faces Pain Rating Scale (WBS)" and "Child Fear Scale (CFS)". In the research, "cartoon" and "musical-moving toy" were used as intervention tools. Two different cartoons were used in the research, and these were the children's favorites, 'Red Fish' and 'Niloya'. Pepee is a toy suitable for the developmental characteristics of children aged three and over. The data were analyzed with the SPSS for Windows 22 package program. Ethical principles were followed in the research. The research sample is limited to pediatric patients who applied to Atatürk University Health Research and Application Center Pediatric Emergency Service between June and December 2021 and participated in the study voluntarily. Research results can be generalized to this group.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Center
      • Erzurum, Center, Turkey, 25240
        • Ataturk University Nursing of Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • between 3-6 years old,
  • Does not have a chronic disease,
  • Does not have a disability related to developmental areas,
  • Not receiving inpatient treatment in the hospital,
  • No history of sedative, analgesic or narcotic substance use within 24 hours before admission,
  • Not having a febrile illness at the time of application,
  • Children whose parents were with the child during the procedure were included in the study.

Exclusion Criteria:

  • NOT aged between 3-6 years,
  • Having a chronic illness
  • Having a disability related to developmental areas,
  • Receiving inpatient treatment in the hospital,
  • Having a history of sedative, analgesic or narcotic substance use within 24 hours before admission,
  • Having a febrile illness at the time of application,
  • Children whose parents were not present during the procedure were included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cartoons
Reduce Pain and Fear Levels of Children
cartoons were found to be effective in reducing children's pain and fear levels.
Experimental: Musical-moving Toys
Reduce Pain and Fear Levels of Children
musical-moving toys were found to be effective in reducing children's pain and fear levels.
No Intervention: CONTROL
NOT Reduce Pain and Fear Levels of Children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wong-Baker Facial Expression Rating Scale
Time Frame: 8 MONTHS
This scale is used to diagnose pain in children aged 3-18 years. In this scale, there are six facial expressions representing the increasing pain intensity from 0 to 5 from left to right. The leftmost facial expression has a smiling expression indicating a pain-free state, while the rightmost facial expression has a crying expression corresponding to the most severe pain. The child is instructed to choose the face that best expresses his or her feelings. Six facial expressions are scored between 0-5 points from left to right (0 points = very happy/no pain, 5 points = indicates the most severe pain). As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.
8 MONTHS
Child Fear Scale
Time Frame: 8 MONTHS
The CLS is a scale of 0-4, showing five faces ranging from a neutral expression (0 = no concern) to the feared face (4 = severe anxiety). The child is told to choose the best facial expression that expresses his or her feelings. As the score obtained from the scale increases, the child's fear level increases.
8 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2021

Primary Completion (Actual)

December 27, 2021

Study Completion (Actual)

February 19, 2022

Study Registration Dates

First Submitted

March 19, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • B.30.2.ATA.O.oı.OO/36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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