NCT07371026

Brief Summary

THE EFFECT OF USİNG DİSTRACTOR CARDS AND THERMOCHROMİC CARDS ON PAİN, FEAR, ANXİETY AND PROCEDURE TİME İN CHİLDREN RECEİVİNG INHALER THERAPY. Respiratory illnesses in children are a leading cause of childhood morbidity and mortality worldwide. Organizations such as the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) report that millions of children are hospitalized each year due to respiratory illnesses (He, Wang, \& Zhang, 2025). A large proportion of these illnesses are caused by viral agents, and pathogens such as Respiratory Syncytial Virus (RSV), influenza, and rhinoviruses pose serious health threats to young children (Chen, Zhang, \& Li, 2024). This study will be one of the rare studies in pediatric nursing that examines the effectiveness of non-pharmacological interventions that can be applied during inhaler therapy in young age groups. The findings will contribute to nurses developing effective methods to reduce the negative emotions experienced by children during treatment. Furthermore, the first-ever use of thermochromic cards in this context in pediatric nursing will provide an innovative perspective on pediatric nursing practices. H0: Thermochromic cards and distraction cards used during inhaler therapy have no effect on pain, fear, anxiety levels, or processing time. Thermochromic cards used during inhaler therapy: H1: reduce the child's pain. H2: reduce the child's fear. H3: reduce the child's anxiety level. H4: shorten the child's processing time. Distraction cards used during inhaler therapy: H5: reduce the child's pain. H6: reduce the child's fear. H7: reduce the child's anxiety level. H8: shorten the child's processing time.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Mar 2026

Status
not yet recruiting

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 Progress19%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

January 5, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 5, 2026

Last Update Submit

January 28, 2026

Conditions

Keywords

pediatricsnebulizer therapythermochromic cardchilddistracting card

Outcome Measures

Primary Outcomes (3)

  • Fear level before, during, and after inhalation therapy assessed by the Child Fear Scale (ÇKÖ)

    Fear level will be assessed using the Child Fear Scale (ÇKÖ), a self-report scale consisting of six facial expressions and scored from 0 to 10 in increments of two points. Higher scores indicate greater levels of fear.

    Before inhalation therapy, during the procedure, and up to 5 minutes after completion of inhalation therapy

  • Pain intensity before, during, and after inhalation therapy assessed by the Wong-Baker FACES Pain Rating Scale

    Pain intensity will be measured using the Wong-Baker FACES Pain Rating Scale, which consists of six facial expressions scored from 0 to 10, where higher scores represent greater pain intensity.

    Before inhalation therapy, during the procedure, and up to 5 minutes after completion of inhalation therapy

  • Anxiety level before, during, and after inhalation therapy assessed by the Child Anxiety Scale-State (ÇAS-D)

    Anxiety level will be assessed using the Child Anxiety Scale-State (ÇAS-D), a thermometer-shaped self-report scale developed for children aged 4-10 years. Higher marked levels indicate higher state anxiety.

    Before inhalation therapy, during the procedure, and up to 5 minutes after completion of inhalation therapy

Secondary Outcomes (1)

  • Duration of inhalation therapy

    During inhalation therapy

Study Arms (3)

thermochromic card

EXPERIMENTAL

The thermochromic card aims to distract the child's attention.

Other: thermochromic card

distraction card

EXPERIMENTAL

The distraction card aims to divert the child's attention to something else.

Other: distraction card

clinic's routine inhaler treatment group

NO INTERVENTION

the group in which routine inhaler therapy is applied and no additional intervention is required

Interventions

Distraction with thermochromic card

Also known as: Termokromik kart
thermochromic card

A distraction card is a visual aid used during medical procedures to reduce a child's perception of pain and fear by diverting their focus away from the procedure and towards the card.

distraction card

Eligibility Criteria

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

You may qualify if:

  • The child must be between 4-6 years old,
  • The child must be receiving inhaler treatment,
  • The child must not have received IV or IM intervention before inhaler treatment,
  • The child's oxygen saturation must be 95% or higher,
  • The child's cognitive level and motor development must be appropriate for their age,
  • The child and parents must be willing to participate in the study,
  • The child and parents must be able to speak Turkish.

You may not qualify if:

  • The child must have a cognitive or mental problem,
  • The child must have special needs in terms of hearing, vision and/or speech,
  • The child must have a life-threatening condition,
  • The child's oxygen saturation level must be below 95%,
  • The child must not be routinely receiving inhaler treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Muhammed Ata Nur GEÇER, MsC, PhD (Candicate)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 27, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

January 30, 2026

Record last verified: 2026-01