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Completed

NCT Number: NCT06486389

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

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.

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Key information

Conditions

Fear Anxiety Behavior Personal Satisfaction Satisfaction

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TÜRKİYE

Edirne, Merkez, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

reading fairy tales

Device

Reading fairy tales during inhaler medication administration.

painting

Device

painting during inhaler medication administration

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Child Fear Scale

    Time frame: within 10 minutes after inhaler treatment

    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

  2. Child Emotional Manifestation Scale

    Time frame: within 10 minutes after inhaler treatment

    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

  3. PedsQL Health Care Parental Satisfaction Scale

    Time frame: within 10 minutes after inhaler treatment

    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

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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