The Effect of Reading Fairy Tales and Coloring on Children's Fear Level in Children Who Are Administered Inhaler Medication With a Mask.

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

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.

Study Overview

• Status: Completed
• Conditions: Satisfaction; Fear Anxiety
• Intervention / Treatment: Device: reading fairy tales; Device: painting

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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Edirne, Merkez, Turkey
      • Türkiye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: distraction methods; reading fairy tales	Device: reading fairy tales; Reading fairy tales during inhaler medication administration.
Experimental: distraction method; painting	Device: painting; painting during inhaler medication administration
No Intervention: Control Grup; Routine Treatment Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal data collection form	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.	baseline
Child Fear Scale	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.	baseline
Child Emotional Manifestation Scale	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.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Fear Scale	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 by the child within 10 minutes of treatment	within 10 minutes after inhaler treatment
Child Emotional Manifestation Scale	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. inhaler was filled by the researcher within 10 minutes of treatment	within 10 minutes after inhaler treatment
PedsQL Health Care Parental Satisfaction Scale	This scale was created to evaluate parents' satisfaction with health care and to increase the level of satisfaction with health care; It consists of six subheadings and 25 questions: information, family participation, communication, technical skills, emotional needs and general satisfaction. The statements in the PedsQL Health Care Satisfaction Scale are; never satisfied = 0, sometimes satisfied = 25, It was quantified with a score of most of the time = 50, almost always satisfied = 75, always satisfied = 100 points. inhaler filled by parent within 10 minutes of treatment	within 10 minutes after inhaler treatment

Collaborators and Investigators

• Sponsor: Trakya University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): January 20, 2024
• Study Completion (Actual): January 20, 2024

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: June 30, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 30, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Satisfaction; Fear; Coloring; Inhaler medicine; Readin Fairy Tales
• Other Study ID Numbers: TÜTF-GOBAEK 2022/318

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No