NCT06486389

Brief Summary

This thesis study was conducted as an unblinded, randomized controlled experiment to examine the effects of reading and coloring fairy tales, which can be used during inhaler medication administration with a mask, on children's fear level and parental health care satisfaction.

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 Sep 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

March 12, 2024

Last Update Submit

June 30, 2024

Conditions

Keywords

Inhaler medicineFearReadin Fairy TalesColoringSatisfaction

Outcome Measures

Primary Outcomes (3)

  • Personal data collection form

    The data collection form was prepared by the researchers in line with the literature. In this form 8 questions about the characteristics of children.There are 18 questions in total, 10 of which include parent and family characteristics.

    baseline

  • Child Fear Scale

    The scale was developed to determine the anxiety level of children aged 5-10 years. There are various facial expressions in the scale and a numerical value is given for each facial expression. The lowest score obtained from the scale is "0" and the highest score is "4". The higher the score obtained from the scale, the higher the level of anxiety felt in the child. The inhaler was filled by the child before medication administration.

    baseline

  • Child Emotional Manifestation Scale

    In the scale, emotional indicators are evaluated in terms of 5 parameters. These parameters are; facial expression, voice, activity, interaction and cooperation level. These five parameters are scored from 1 to 5, and the lowest "5" and the highest "25" points are obtained at the end of the evaluation of the scale. A low score from the scale indicates a positive emotional state, and an increase in a score indicates a negative emotional state. The inhaler was filled out by the researcher before drug administration.

    baseline

Secondary Outcomes (3)

  • Child Fear Scale

    within 10 minutes after inhaler treatment

  • Child Emotional Manifestation Scale

    within 10 minutes after inhaler treatment

  • PedsQL Health Care Parental Satisfaction Scale

    within 10 minutes after inhaler treatment

Study Arms (3)

distraction methods

EXPERIMENTAL

reading fairy tales

Device: reading fairy tales

distraction method

EXPERIMENTAL

painting

Device: painting

Control Grup

NO INTERVENTION

Routine Treatment Group

Interventions

Reading fairy tales during inhaler medication administration.

distraction methods
paintingDEVICE

painting during inhaler medication administration

distraction method

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parent and child volunteering to participate in the study,
  • The child is between the ages of 3-6,
  • Being admitted due to respiratory system disease,
  • Inhaler treatment with a mask will be applied.

You may not qualify if:

  • Parent and child not voluntarily participating in the study,
  • 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)

TÜRKİYE

Edirne, Merkez, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Chromosome Painting

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

In Situ Hybridization, FluorescenceIn Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesCytogenetic AnalysisGenetic TechniquesNucleic Acid Hybridization

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

March 12, 2024

First Posted

July 3, 2024

Study Start

September 15, 2023

Primary Completion

January 20, 2024

Study Completion

January 20, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Locations