NCT05415566

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

1.1 years

First QC Date

June 8, 2022

Last Update Submit

June 10, 2022

Conditions

Keywords

Toy MaskToy NebulizerChildNurse

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Reducing the "Child Fear Scale" score

    shortly after inhaler treatment

  • Reducing the "Child Anxiety Scale-Stateness" score

    shortly after inhaler treatment

Study Arms (2)

Routine Treatment Group

NO INTERVENTION

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

Therapeutic Play Group

EXPERIMENTAL

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

Combination Product: toy nebulizer and toy mask

Interventions

toy nebulizer and toy maskCOMBINATION_PRODUCT

The treatment was administered using therapeutic play.

Therapeutic Play Group

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, Bornova, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 13, 2022

Study Start

February 8, 2021

Primary Completion

March 31, 2022

Study Completion

June 3, 2022

Last Updated

June 14, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations