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CompletedNCT05303454Updated Mar 31, 2022

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

An interventional study of Cartoons and musical-moving toys in Pediatric Disorder, sponsored by Ataturk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Ataturk University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Mar 2021, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pediatric Disorder
03

In context

Lead sponsor

Ataturk University is the lead sponsor of 456 studies on the registry; 124 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Cartoons

    Reduce Pain and Fear Levels of Children

    Behavioral: Cartoons

  • Experimental
    Musical-moving Toys

    Reduce Pain and Fear Levels of Children

    Behavioral: musical-moving toys

  • No intervention
    CONTROL

    NOT Reduce Pain and Fear Levels of Children

Interventions

  • BehavioralCartoons

    cartoons were found to be effective in reducing children's pain and fear levels.

  • Behavioralmusical-moving toys

    musical-moving toys were found to be effective in reducing children's pain and fear levels.

06

What researchers measure

Primary outcomes

  1. Wong-Baker Facial Expression Rating Scale

    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.

    Time frame: 8 MONTHS

  2. Child Fear Scale

    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.

    Time frame: 8 MONTHS

07

Study locations

1 site
  • Ataturk University Nursing of Faculty
    Erzurum, Center 25240, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: No — THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2021 to primary completion in Dec 2021, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2022
First posted
Mar 31, 2022
StartActual
Mar 19, 2021
Primary completionActual
Dec 27, 2021
CompletionActual
Feb 19, 2022
Last update
Mar 31, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05303454
Lead sponsor
Ataturk University
Responsible party
ARZU SARIALİOĞLU (Principal Investigator, Ataturk University) — Principal investigator
First posted
Mar 31, 2022
Start date
Mar 19, 2021
Primary completion
Dec 27, 2021
Completion
Feb 19, 2022
Last update
Mar 31, 2022

Study contacts

ARZU SARIALİOĞLU, PHD
study director · Ataturk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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