NCT05303454

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2022

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

March 19, 2022

Last Update Submit

March 29, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    8 MONTHS

  • 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.

    8 MONTHS

Study Arms (3)

Cartoons

EXPERIMENTAL

Reduce Pain and Fear Levels of Children

Behavioral: Cartoons

Musical-moving Toys

EXPERIMENTAL

Reduce Pain and Fear Levels of Children

Behavioral: musical-moving toys

CONTROL

NO INTERVENTION

NOT Reduce Pain and Fear Levels of Children

Interventions

CartoonsBEHAVIORAL

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

Cartoons

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

Musical-moving Toys

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Nursing of Faculty

Erzurum, Center, 25240, Turkey (Türkiye)

Location

Study Officials

  • ARZU SARIALİOĞLU, PHD

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 19, 2022

First Posted

March 31, 2022

Study Start

March 19, 2021

Primary Completion

December 27, 2021

Study Completion

February 19, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED

Locations