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

Primary Purpose

Therapeutic Play, Anxiety, Fear

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
toy nebulizer and toy mask
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Therapeutic Play focused on measuring Toy Mask, Toy Nebulizer, Child, Nurse

Eligibility Criteria

3 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ege University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Routine Treatment Group

Therapeutic Play Group

Arm Description

Inhaler treatment was applied according to the routine procedure in the emergency department.

Inhaler treatment was applied according to the "Therapeutic Play Guide" prepared by the researcher.

Outcomes

Primary Outcome Measures

Reducing the child's fear
Reducing the child's fear during inhaler treatment
Reducing the child's anxiety
Reducing the child's anxiety during inhaler treatment

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 8, 2022
Last Updated
June 10, 2022
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT05415566
Brief Title
The Effect of Therapeutic Play Applied by Using Toy Nebulizer and Toy Mask on Child's Fear and Anxiety Level
Official Title
The Effect of Therapeutic Play Applied by Using Toy Nebulizer and Toy Mask on Child's Fear and Anxiety Level
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
June 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Therapeutic Play, Anxiety, Fear
Keywords
Toy Mask, Toy Nebulizer, Child, Nurse

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The population of the randomized controlled experimental study was composed of children aged 3-8 years who applied to the pediatric emergency department due to respiratory system disease.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine Treatment Group
Arm Type
No Intervention
Arm Description
Inhaler treatment was applied according to the routine procedure in the emergency department.
Arm Title
Therapeutic Play Group
Arm Type
Experimental
Arm Description
Inhaler treatment was applied according to the "Therapeutic Play Guide" prepared by the researcher.
Intervention Type
Combination Product
Intervention Name(s)
toy nebulizer and toy mask
Intervention Description
The treatment was administered using therapeutic play.
Primary Outcome Measure Information:
Title
Reducing the child's fear
Description
Reducing the child's fear during inhaler treatment
Time Frame
during inhaler treatment
Title
Reducing the child's anxiety
Description
Reducing the child's anxiety during inhaler treatment
Time Frame
during inhaler treatment
Secondary Outcome Measure Information:
Title
Reducing the "Child Fear Scale" score
Description
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.
Time Frame
shortly after inhaler treatment
Title
Reducing the "Child Anxiety Scale-Stateness" score
Description
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.
Time Frame
shortly after inhaler treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Parent and child volunteering to participate in the study, The child is between the ages of 3-8, Being admitted due to respiratory system disease, Inhaler treatment with a nebulizer will be applied. Exclusion Criteria: Parent and child not voluntarily participating in the study, Intravenous, intramuscular or any other treatment request, The child has any genetic, congenital, chronic or metabolic disease, The child has vision, hearing and speech problems, The child's vital signs are unstable (no fever, tachypnea, etc.) and the need for any emergency intervention.
Facility Information:
Facility Name
Ege University
City
İzmir
State/Province
Bornova
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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