Clinical trial NCT06486389: The Effect of Reading Fairy Tales and Coloring on Children's Fear Level in Children Who Are Administered Inhaler Medication With a Mask.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear Anxiety
Satisfaction
Keywords: Inhaler medicine
Fear
Readin Fairy Tales
Coloring
Satisfaction
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 99
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Personal data collection form
timeFrame: baseline
measure: Child Fear Scale
timeFrame: baseline
measure: Child Emotional Manifestation Scale
timeFrame: baseline
Secondary outcomes:
measure: Child Fear Scale
timeFrame: within 10 minutes after inhaler treatment
measure: Child Emotional Manifestation Scale
timeFrame: within 10 minutes after inhaler treatment
measure: PedsQL Health Care Parental Satisfaction Scale
timeFrame: within 10 minutes after inhaler treatment
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: TÜRKİYE
state: Merkez
Study officials:
References: