Fear AnxietyNCT06486389
The Effect of Reading Fairy Tales and Coloring on Children's Fear Level in Children Who Are Administered Inhaler Medication With a Mask.
A study testing reading fairy tales and painting in people with Fear Anxiety and Satisfaction, run by Trakya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Fear Anxiety, Satisfaction
- What is being tested?
- reading fairy tales and painting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 20 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Fear Anxiety, Satisfaction
- Being tested
- reading fairy tales, painting
- Keywords
- Inhaler medicine, Fear, Readin Fairy Tales, Coloring, Satisfaction
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reading fairy talesDevice
Reading fairy tales during inhaler medication administration.
paintingDevice
painting during inhaler medication administration
| Study group | Role | What they receive |
|---|---|---|
| distraction methods | Experimental | reading fairy tales Receives: Device: reading fairy tales |
| distraction method | Experimental | painting Receives: Device: painting |
| Control Grup | No intervention | Routine Treatment Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: baseline
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: within 10 minutes after inhaler treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start15 Sep 2023
- Primary completion20 Jan 2024
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuray Macuncu, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486389
- Sponsor's protocol ID
- TÜTF-GOBAEK 2022/318
- Status last verified
- Jun 2024
- First submitted
- 12 Mar 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06486389
- Acronym / sponsor ID
- TÜTF-GOBAEK 2022/318
- Conditions
- Fear Anxiety, Satisfaction
- Keywords
- Inhaler medicine, Fear, Readin Fairy Tales, Coloring, Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care
| Arm | Type | Receives |
|---|---|---|
| distraction methods | Experimental | Device: reading fairy talesreading fairy tales |
| distraction method | Experimental | Device: paintingpainting |
| Control Grup | No intervention | –Routine Treatment Group |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reading fairy talesReading fairy tales during inhaler medication administration. | Device | distraction methods |
| paintingpainting during inhaler medication administration | Device | distraction method |
Primary outcome
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 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.
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.
3 secondary outcomes
Child Fear Scale
Time frame: within 10 minutes after inhaler treatment
Child Emotional Manifestation Scale
Time frame: within 10 minutes after inhaler treatment
PedsQL Health Care Parental Satisfaction Scale
Time frame: within 10 minutes after inhaler treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reading fairy tales and painting in people with Fear Anxiety and Satisfaction, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal data collection form (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.