The Effect of Therapeutic Play Applied by Using Toy Nebulizer and Toy Mask on Child's Fear and Anxiety Level

Anxiety Clinical Trial

Official title:

The Effect of Therapeutic Play Applied by Using Toy Nebulizer and Toy Mask on Child's Fear and Anxiety Level

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05415566
• Other study ID #: 21116
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Fear

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