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Clinical Trials/NCT06486389
NCT06486389
Completed
Not Applicable

The Effect of Reading Fairy Tales and Coloring on Children's Fear Level and Parental Health Care Satisfaction in Children Aged 3-6 Years Who Are Administered Inhaler Drugs

Trakya University1 site in 1 country99 target enrollmentSeptember 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fear Anxiety
Sponsor
Trakya University
Enrollment
99
Locations
1
Primary Endpoint
Child Fear Scale
Status
Completed
Last Updated
last year

Overview

Brief Summary

This thesis study was conducted as an unblinded, randomized controlled experiment to examine the effects of reading and coloring fairy tales, which can be used during inhaler medication administration with a mask, on children's fear level and parental health care satisfaction.

Detailed Description

Data were collected at Edirne Sultan 1. Murat State Hospital Pediatrics Clinic between September 2023 and January 2024. Children aged 3-6 were included in the study. In the research, the sample was divided into three groups. 99 children participated in the study, 33 children in each group. Using the randomization program, it was determined which sample group the children would be included in. In the study, reading fairy tales and coloring were used as distraction methods for the experimental group. Inhaler medication was administered via mask to the control group without any application. The implementation period of the research lasted an average of four months. Necessary ethical permissions were obtained before the research. In the study, the Child Fear Scale was used to measure the level of fear, the PedsQL Health Care Satisfaction Scale was used to measure parental satisfaction, and the Children's Emotional Indicators Scale was used to measure emotional indicators. Explanatory information about the application was given to the children and their parents by the researcher, and they were voluntarily informed and signed a consent form. Research data were collected by the researcher by meeting children and parents face to face.

Registry
clinicaltrials.gov
Start Date
September 15, 2023
End Date
January 20, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nuray Macuncu

Nurse

Trakya University

Eligibility Criteria

Inclusion Criteria

  • Parent and child volunteering to participate in the study,
  • The child is between the ages of 3-6,
  • Being admitted due to respiratory system disease,
  • Inhaler treatment with a mask will be applied.

Exclusion Criteria

  • Parent and child not voluntarily participating in the study,
  • The child has any genetic, congenital, chronic or metabolic disease,
  • The child has vision, hearing and speech problems,
  • The child's vital signs are unstable (no fever, tachypnea, etc.) and the need for any emergency intervention.

Outcomes

Primary Outcomes

Child Fear Scale

Time Frame: baseline

The scale was developed to determine the anxiety level of children aged 5-10 years. There are various facial expressions in the scale and a numerical value is given for each facial expression. The lowest score obtained from the scale is "0" and the highest score is "4". The higher the score obtained from the scale, the higher the level of anxiety felt in the child. The inhaler was filled by the child before medication administration.

Personal data collection form

Time Frame: baseline

The data collection form was prepared by the researchers in line with the literature. In this form 8 questions about the characteristics of children.There are 18 questions in total, 10 of which include parent and family characteristics.

Child Emotional Manifestation Scale

Time Frame: baseline

In the scale, emotional indicators are evaluated in terms of 5 parameters. These parameters are; facial expression, voice, activity, interaction and cooperation level. These five parameters are scored from 1 to 5, and the lowest "5" and the highest "25" points are obtained at the end of the evaluation of the scale. A low score from the scale indicates a positive emotional state, and an increase in a score indicates a negative emotional state. The inhaler was filled out by the researcher before drug administration.

Secondary Outcomes

  • PedsQL Health Care Parental Satisfaction Scale(within 10 minutes after inhaler treatment)
  • Child Emotional Manifestation Scale(within 10 minutes after inhaler treatment)
  • Child Fear Scale(within 10 minutes after inhaler treatment)

Study Sites (1)

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