About this trial
In recent decades, the prevalence of allergic diseases, particularly respiratory allergies, has risen significantly. In childhood, house dust mites are the primary indoor allergen in infancy, while the prevalence of pollen sensitization increases with age. As one of the largest immunologic organs, the skin frequently displays allergic responses; therefore, the Skin Prick Test (SPT) is widely used for diagnostic purposes. SPT is quick, cost-effective, highly sensitive, and rarely causes adverse effects, yet it may still induce stress or anxiety in children-especially younger ones or when applied on the back.
Although distraction methods (e.g., toys, games, DistrACTION® Cards) are commonly used to reduce discomfort in minimally invasive pediatric procedures, there is limited research on strategies to alleviate stress during SPT. This randomized controlled trial (RCT) aims to investigate the impact of pet therapy using betta fish on children's emotional symptoms (such as anger or irritability) and physiological parameters during SPT. The study will include 80 children, aged 3-6, who attend a pediatric allergy clinic between April 2025 and April 2026. Participants will be randomly assigned to control or experimental groups through simple and block randomization, ensuring age balance. Data collection instruments include a Personal Information Form, the Children's Emotional Indicator Scale, FLACC Pain Scale, and a Physiological Parameter Monitoring Form.
The study posits two main hypotheses:
Pet therapy positively affects emotional indicators of children based on their age.
Pet therapy influences physiological parameters by age group. Findings from this research may inform evidence-based interventions to reduce stress and anxiety in pediatric patients undergoing minimally invasive procedures like SPT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
No previous allergy testing
3-6 years old
Stable hemodynamics
No chronic disease
Disqualifiers
The child does not meet the inclusion criteria
The mother does not meet the inclusion criteria
Child's and mother's unwillingness to participate in the study
Trial design
Parallel
Treatments tested in this trial
animal assisted therapy
BehavioralThe Children's Emotional Indicator Scale (Facial expression, Vocalization, Activity, Interaction and Cooperation Level) will be used to provide a simple, objective and consistent method to determine children's emotional behavior during stressful medical procedures. The FLACC scale will be used for pain. In addition, all physiological parameters including pulse rate, saturation value and respiration will be measured and recorded with a pulse oximeter device. Animal assisted therapy will be applied to the participants in the study group to reduce the stress of the children. In animal-assisted therapy, the child will be shown a fish in a glass bowl and a red fish song will accompany the process. In the study, participant children will be randomly assigned to intervention and control groups.
Treatment groups
Trial outcomes
Primary outcomes
reduce children's stress and pain during allergy testing
Children's pain and stress during the procedure were measured using validated scales or physiological parameters. CEMS consists of five categories of observable emotional behaviors (Facial expression, Vocalization, Activity, Interaction, and Level of cooperation). Each category has a value between 1-5. The total score that can be obtained from the scale varies between 5-25. The higher the scores obtained from the scale, the higher the negative emotional indicators. FLACC Pain Scale is used in awake patients by observation for 1 to 5 minutes. The scale consists of five elements: face, leg, movement, crying, activity status and degree of consolability. Each category is evaluated between 0-2, the total score ranges from 0 to 10. A score of 0 indicates that the child is calm and relaxed, a score of 1-3 indicates that the child is mildly uncomfortable, scores between 4-6 indicate that the child has moderate pain, and a score of 7-10 indicates severe pain.
Locations
Sponsors and contacts
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Mehtap METİN KARAASLAN
Lead sponsor
Recep Tayyip Erdogan University
Sponsor institution
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