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Not yet recruiting NCT07371026

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

No phase Interventional Pediatric Acute Upper Respiratory Tract Infection Pediatric Pediatric Acute Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: thermochromic card, distraction card.
Who it may be relevant to
Registry conditions: Pediatric Acute Upper Respiratory Tract Infection, Pediatric, Pediatric Acute Respiratory Failure. Basic parameters: 3 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • Other thermochromic card
    Distraction with thermochromic card
  • 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.

Primary outcome measures

  • Fear level before, during, and after inhalation therapy assessed by the Child Fear Scale (ÇKÖ) [Time frame: 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 [Time frame: 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) [Time frame: Before inhalation therapy, during the procedure, and up to 5 minutes after completion of inhalation therapy]
Secondary outcome measures (1)
  • Duration of inhalation therapy [Time frame: During inhalation therapy]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07371026 · E-13022260-300-1436826

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗