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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Fear; Therapeutic Play
• Intervention / Treatment: Combination product: toy nebulizer and toy mask

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bornova
    • İzmir, Bornova, Turkey
      • Ege University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 8 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Routine Treatment Group; Inhaler treatment was applied according to the routine procedure in the emergency department.
EXPERIMENTAL: Therapeutic Play Group; Inhaler treatment was applied according to the "Therapeutic Play Guide" prepared by the researcher.	Combination product: toy nebulizer and toy mask; The treatment was administered using therapeutic play.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reducing the child's fear	Reducing the child's fear during inhaler treatment	during inhaler treatment
Reducing the child's anxiety	Reducing the child's anxiety during inhaler treatment	during inhaler treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ege University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2021
• Primary Completion (ACTUAL): March 31, 2022
• Study Completion (ACTUAL): June 3, 2022

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (ACTUAL): June 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Nurse; Child; Toy Mask; Toy Nebulizer
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 21116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No