The Effect of Using Distractor Cards and Thermochromic Cards on Pain, Fear, Anxiety and Procedure Time in Children Receiving Inhaler Therapy
CALM-INH
1 other identifier
interventional
90
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
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
First Submitted
Initial submission to the registry
January 5, 2026
CompletedFirst Posted
Study publicly available on registry
January 27, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
January 30, 2026
January 1, 2026
1 year
January 5, 2026
January 28, 2026
Conditions
Keywords
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
EXPERIMENTALThe thermochromic card aims to distract the child's attention.
distraction card
EXPERIMENTALThe distraction card aims to divert the child's attention to something else.
clinic's routine inhaler treatment group
NO INTERVENTIONthe group in which routine inhaler therapy is applied and no additional intervention is required
Interventions
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.
Eligibility Criteria
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
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