- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07442019
Fear, Emotional Behaviors and Parental Care Satisfaction Related to Inhalation Therapy
Effects of Finger Puppet, Video Game and Stress Ball on Fear, Emotional Behaviors and Parental Care Satisfaction Related to Inhalation Therapy in 4-6 Year Old Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Karaman, Turkey (Türkiye), 7000
- Public Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- the child being between 4-6 years old,
- receiving inhaler treatment via mask,
- not having received inhaler treatment for the last 6 months,
- receiving bronchodilator medications as part of inhaler treatment,
- having no vision or speech problems,
- having no hearing problems,
- the child and parent being able to speak and understand Turkish fluently,
- being willing to participate in the study, and the families agreeing to participate in the research and signing the informed consent form.
Exclusion Criteria:
- the child receiving medications other than bronchodilators as part of inhaler treatment,
- the child and parent not being able to speak or understand Turkish fluently, and not being willing to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Finger Puppet
A "Finger Puppet Scenario Text" was prepared for use with children during inhaler treatment. The finger puppets used in the study were designed specifically for this research, being colorful and wearable on the finger for both boys and girls. This scenario text and the puppets were evaluated by experts. In the finger puppet application, the researcher introduced the finger puppets to the children before inhaler treatment. Then, the finger puppet scenario was implemented by the researcher. This stage lasted approximately 10 minutes. During inhaler treatment, as outlined in the finger puppet scenario text, the puppet remained silent and in a sleep mode (silent play) throughout the treatment, depending on the cooperation between the child and the puppet. The Child Fear Scale and the Emotional Indicators Scale were evaluated and recorded before, during, and after inhaler treatment. The PedsQL Healthcare Satisfaction Scale was evaluated at the end of inhaler treatment. |
Finger Puppet
|
|
Experimental: Video Game
The video game used in the study was selected from among the children's parent's mobile phones and chosen by the child themselves.
Ten minutes before the start of inhaler treatment, the video game was introduced and explained, and the child was asked to start playing and continue playing the video game throughout the inhaler treatment.
The video game playing time lasted approximately 10 minutes.
During inhaler treatment, children in the video game group were allowed to play the video game.
The mask remained on the child while playing the video game.
The Child Fear Scale and Emotional Indicators Scale were evaluated and recorded before, during, and after inhaler treatment.
The PedsQL Healthcare Satisfaction Scale was evaluated at the end of inhaler treatment.
|
Video Game
|
|
Experimental: Stress Ball
In this study, a stress ball was chosen that was soft and sized appropriately for the child's hand.
Children in the stress ball group were given a stress ball before the procedure and asked to squeeze it during the procedure.
Ten minutes before the start of inhaler treatment, the child was given the stress ball, introduced to it, and asked to squeeze, release, and play with it.
The Child Fear Scale and the Emotional Indicators Scale were evaluated and recorded before, during, and after inhaler treatment.
The PedsQL Healthcare Satisfaction Scale was evaluated at the end of inhaler treatment.
|
Stress Ball
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
child fear scale
Time Frame: The child was assessed 5 minutes before inhaler treatment. The child was assessed during inhaler treatment. The child was also assessed immediately after inhaler treatment was completed.
|
The scale can be used to determine the level of fear in children aged 4-10 years.
It is administered by showing the child five facial expressions, ranging from a neutral expression ("0") to a frightened face ("4").
|
The child was assessed 5 minutes before inhaler treatment. The child was assessed during inhaler treatment. The child was also assessed immediately after inhaler treatment was completed.
|
|
children's emotional manifestation scale
Time Frame: The child was assessed 5 minutes before inhaler treatment. The child was assessed during inhaler treatment. The child was also assessed immediately after inhaler treatment was completed.
|
The scale can evaluate children's emotional indicators based on five parameters.
These five parameters are: facial expression, vocal activity, interaction, and level of cooperation.
|
The child was assessed 5 minutes before inhaler treatment. The child was assessed during inhaler treatment. The child was also assessed immediately after inhaler treatment was completed.
|
|
PedsQL health care satisfaction scale
Time Frame: Parents were asked to evaluate and record their satisfaction with the PedsQL Healthcare Satisfaction Scale immediately after the inhaler treatment was completed.
|
The scale includes six main categories: information, family involvement, communication, technical skills, emotional needs, and overall satisfaction.
The scale is evaluated based on the understanding that higher scores indicate higher satisfaction levels.
|
Parents were asked to evaluate and record their satisfaction with the PedsQL Healthcare Satisfaction Scale immediately after the inhaler treatment was completed.
|
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
Other Study ID Numbers
- KMU-SBF-VAC-01
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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