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NCT Number: NCT07371026

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

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.

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Key information

Conditions

Pediatric Acute Upper Respiratory Tract Infection Pediatric Pediatric Acute Respiratory Failure

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thermochromic card

Other

Distraction with thermochromic card

Other names: Termokromik kart

distraction card

Other

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 outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

Secondary outcomes

  1. Duration of inhalation therapy

    Time frame: During inhalation therapy

    Procedure duration will be recorded in minutes from the start to the completion of inhalation therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammed Ata Nur GEÇER, MsC, PhD (Candicate)

CONTACT

[email protected]

+905455258654

Sponsors and collaborators

Lead sponsor

Muhammed Ata Nur GEÇER

Other

Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Registry information

Acronym: CALM-INH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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