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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05415566
Other study ID # 21116
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 8, 2021
Est. completion date June 3, 2022

Study information

Verified date June 2022
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, it was aimed to examine the effect of therapeutic play applied with a toy nebulizer and toy mask before inhaler treatment on children's fear and anxiety. It is the hypothesis of the study that the therapeutic play applied by using a toy mask and a toy nebulizer before inhaler treatment in children will reduce the child's fear and anxiety.


Description:

Acute diseases constitute the majority of applications made to pediatric emergency services. Inhaled drugs are frequently used in the treatment of childhood acute respiratory system diseases. Nebulizers are the preferred method of administering inhaled drugs. Medical procedures are one of the biggest fears of children, making it difficult to use nebulizers correctly and effectively. The negative reaction of the child to the mask and nebulizer during inhaler treatment causes incorrect inhalation patterns, reducing the safety and effectiveness of the treatment. This causes difficulties in relieving symptoms, increased hospital admission and hospitalization time, more treatment costs, and even negative consequences such as increased morbidity. Reducing the fear and anxiety seen in children due to the hospital environment and illness is important in terms of children's acceptance of the treatment process. One of the methods used for this purpose is therapeutic play. Pediatric nurses should fulfill their nursing roles and responsibilities by including therapeutic play in their care processes.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date June 3, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 8 Years
Eligibility Inclusion Criteria: 1. Parent and child volunteering to participate in the study, 2. The child is between the ages of 3-8, 3. Being admitted due to respiratory system disease, 4. Inhaler treatment with a nebulizer will be applied. Exclusion Criteria: 1. Parent and child not voluntarily participating in the study, 2. Intravenous, intramuscular or any other treatment request, 3. The child has any genetic, congenital, chronic or metabolic disease, 4. The child has vision, hearing and speech problems, 5. The child's vital signs are unstable (no fever, tachypnea, etc.) and the need for any emergency intervention.

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
toy nebulizer and toy mask
The treatment was administered using therapeutic play.

Locations

Country Name City State
Turkey Ege University Izmir Bornova

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reducing the child's fear Reducing the child's fear during inhaler treatment during inhaler treatment
Primary Reducing the child's anxiety Reducing the child's anxiety during inhaler treatment during inhaler treatment
Secondary Reducing the "Child Fear Scale" score The Child Fear Scale (CFS) used. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. The rater responds indicates the level of fear. Scores range from 0 to 4. shortly after inhaler treatment
Secondary Reducing the "Child Anxiety Scale-Stateness" score The Children's Anxiety Meter (CAM) used. It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety. Scores range from 0 to 10. shortly after inhaler treatment
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