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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07371026
Acronym
CALM-INH
Enrollment
90
Registered
2026-01-27
Start date
2026-03-01
Completion date
2027-03-01
Last updated
2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric, Pediatric Acute Respiratory Failure, Pediatric Acute Upper Respiratory Tract Infection

Keywords

pediatrics, nebulizer therapy, thermochromic card, child, distracting card

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.

Interventions

OTHERthermochromic card

Distraction with 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.

Sponsors

Muhammed Ata Nur GEÇER
Lead SponsorOTHER
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
CollaboratorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fear level before, during, and after inhalation therapy assessed by the Child Fear Scale (ÇKÖ)Before inhalation therapy, during the procedure, and up to 5 minutes after completion of inhalation therapyFear 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.
Pain intensity before, during, and after inhalation therapy assessed by the Wong-Baker FACES Pain Rating ScaleBefore inhalation therapy, during the procedure, and up to 5 minutes after completion of inhalation therapyPain 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.
Anxiety level before, during, and after inhalation therapy assessed by the Child Anxiety Scale-State (ÇAS-D)Before inhalation therapy, during the procedure, and up to 5 minutes after completion of inhalation therapyAnxiety 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.

Secondary

MeasureTime frameDescription
Duration of inhalation therapyDuring inhalation therapyProcedure duration will be recorded in minutes from the start to the completion of inhalation therapy.

Contacts

CONTACTMuhammed Ata Nur GEÇER, MsC, PhD (Candicate)
mangecer0@gmail.com+905455258654

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026