The Effect of Using Distractor Cards and Thermochromic Cards on Pain, Fear, Anxiety and Procedure Time in Children Receiving Inhaler Therapy (CALM-INH)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric; Pediatric Acute Upper Respiratory Tract Infection; Pediatric Acute Respiratory Failure
• Intervention / Treatment: Other: thermochromic card; Other: distraction card

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammed Ata Nur GEÇER, MsC, PhD (Candicate); Phone Number: +905455258654; Email: mangecer0@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: thermochromic card; The thermochromic card aims to distract the child's attention.	Other: thermochromic card; Distraction with thermochromic card; Other Names: Termokromik kart
Experimental: distraction card; The distraction card aims to divert the child's attention to something else.	Other: distraction 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.
No Intervention: clinic's routine inhaler treatment group; the group in which routine inhaler therapy is applied and no additional intervention is required

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of inhalation therapy	Procedure duration will be recorded in minutes from the start to the completion of inhalation therapy.	During inhalation therapy

Collaborators and Investigators

• Sponsor: Muhammed Ata Nur GEÇER
• Collaborators: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: pediatrics; child; nebulizer therapy; thermochromic card; distracting card
• Other Study ID Numbers: E-13022260-300-1436826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No