NCT07029633

Brief Summary

Inhalation therapy with a nebulizer is a non-invasive and easy-to-use technology. However, the use of masks and the loud, unpleasant sound of the nebulizer can cause fear and anxiety in children. For nebulizer inhalation therapy to be effective, it is important to reduce children's fear and anxiety and to increase their compliance with treatment. Simple and inexpensive distraction methods can be used to achieve this. The results show that cartoon and storytelling methods reduce fear and anxiety in children undergoing inhalation therapy with the nebulizer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

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

January 2, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

10 months

First QC Date

June 11, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

anxietychildfearcartoonstorytelling

Outcome Measures

Primary Outcomes (4)

  • fear level

    The Child Fear Scale (CFS) was used children's fear level

    15-30 minute

  • anxiety level

    To determite anxiety level of children The Children's Anxiety Meter-State (CAM-S) was used.

    15-30 minute

  • crying duration

    The crying duration of the children during the procedure was measured and recorded by the researchers with a stopwatch.

    15-30 minute

  • Cardiorespiratory rates:

    Children's respiration rate was measured by observation, pulse rate and SPO2 levels were measured by finger pulse oximeter.

    15-30 minute

Study Arms (3)

Group 1

EXPERIMENTAL

To reduce fear and anxiety in the children in this group, the storytelling method was used by the parents during the nebulizer treatments.

Other: storytelling

Group 2

EXPERIMENTAL

During nebulizer treatments, children in this group collaboratively chose cartoons on YouTube with their parents and watched them on phones using the hospital's internet.

Other: cartoon

Group 3

NO INTERVENTION

No intervention was performed on the children in the control group to reduce fear and anxiety related to inhalation therapy with a nebulizer.

Interventions

to distract telling a story

Group 1
cartoonOTHER

to distract watching a cartoon

Group 2

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children between 5 and 8 years old, who received inhalation therapy with a nebulizer for the first time, had no communication problems, and gave consent were included in the study.

You may not qualify if:

  • Children who had vision, hearing, and comprehension problems, mental and neurological diseases, life-threatening diseases, those who used any medication with sedative effects, or those who refused interventions during nebule treatment were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sibel Serap Ceylan

Denizli, Pamukkale, 20000, 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: randomized controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, PhD, RN

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 19, 2025

Study Start

January 2, 2023

Primary Completion

October 15, 2023

Study Completion

October 30, 2023

Last Updated

June 19, 2025

Record last verified: 2025-06

Locations