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

Muhammed Ata Nur GEÇER

Status: Begins enrollment this month

Conditions: Pediatric Acute Respiratory Failure; Pediatric; Pediatric Acute Upper Respiratory Tract Infection

Treatments: Other: distraction card; Other: thermochromic card

Study type: Interventional

Funder types: Other

Identifiers

NCT07371026

E-13022260-300-1436826

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

thermochromic card

Experimental group

Description:

The thermochromic card aims to distract the child's attention.

Treatment:

Other: thermochromic card

distraction card

Experimental group

Description:

The distraction card aims to divert the child's attention to something else.

Treatment:

Other: distraction card

clinic's routine inhaler treatment group

No Intervention group

Description:

the group in which routine inhaler therapy is applied and no additional intervention is required