- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07029633
- Original Trial
Effect of Cartoon and Storytelling on the Children's Fear and Anxiety Levels During Inhalation Therapy With Nebulizer in Emergency Department
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aimed to evaluate the impact of cartoons and storytelling during nebulizer inhalation treatment on procedure-related fear and anxiety in children. This randomized controlled study employed a 3-arm parallel design with 99 children aged 5-8 receiving nebulizer therapy in the pediatric emergency department. Groups 1 and 2 served as the experimental groups, while Group 3 acted as the control group, with no intervention addressing fear and anxiety. Group 1 utilized storytelling as a distraction, while Group 2 watched cartoons. Data were collected using the Descriptive Characteristics Form, the Child Follow-Up Form, the Children's Anxiety Meter-State, and the Child Fear Scale.
In the study, parental presence was ensured during the procedure in all groups. For this reason, parents were informed, and their questions about inhalation treatment with nebulizers were answered before data collection to reduce parents' stress and anxiety in all groups and to prevent children from being affected by their parents' emotional situation. The parents were seated in a comfortable chair beside the children's bed.
Before the inhalation treatment with a nebulizer, the procedure was explained to the child according to the child's developmental level, the fear and anxiety levels of the children were evaluated, and their cardiorespiratory rates were measured. Then, inhalation therapy with a nebulizer was started. During the procedure, children's anxiety levels, crying situations, and cardiorespiratory rates were measured. After the procedure, the nebulizer was turned off, the mask was removed, and their faces were cleaned. The children's fear and anxiety levels were evaluated for the last time, and their cardiorespiratory rates were measured. The duration of the inhalation treatment was approximately 15 minutes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pamukkale
-
Denizli, Pamukkale, Turkey, 20000
- Sibel Serap Ceylan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Children between 5 and 8 years old, who received inhalation therapy with a nebulizer for the first time, had no communication problems, and gave consent were included in the study.
Exclusion Criteria:
Children who had vision, hearing, and comprehension problems, mental and neurological diseases, life-threatening diseases, those who used any medication with sedative effects, or those who refused interventions during nebule treatment were not included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
To reduce fear and anxiety in the children in this group, the storytelling method was used by the parents during the nebulizer treatments.
|
to distract telling a story
|
|
Experimental: Group 2
During nebulizer treatments, children in this group collaboratively chose cartoons on YouTube with their parents and watched them on phones using the hospital's internet.
|
to distract watching a cartoon
|
|
No Intervention: Group 3
No intervention was performed on the children in the control group to reduce fear and anxiety related to inhalation therapy with a nebulizer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
fear level
Time Frame: 15-30 minute
|
The Child Fear Scale (CFS) was used children's fear level
|
15-30 minute
|
|
anxiety level
Time Frame: 15-30 minute
|
To determite anxiety level of children The Children's Anxiety Meter-State (CAM-S) was used.
|
15-30 minute
|
|
crying duration
Time Frame: 15-30 minute
|
The crying duration of the children during the procedure was measured and recorded by the researchers with a stopwatch.
|
15-30 minute
|
|
Cardiorespiratory rates:
Time Frame: 15-30 minute
|
Children's respiration rate was measured by observation, pulse rate and SPO2 levels were measured by finger pulse oximeter.
|
15-30 minute
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PamU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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