Pet Therapy Effects on Pain, Emotional and Physiological Responses in Children Undergoing Allergy Testing

NCT06875999 | Not Yet Recruiting

• 1 other identifier: Allergy skin test
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Allergy Testing; Pain, Emotional Symptoms and Physiological Parameters

Keywords

Allergy Testing; Children; Animal-Assisted Therapy; Emotions

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Study Arms (2)

Control Group: Routine clinical practice

NO INTERVENTION

In the control group, the Personal Information Form, FLACC Pain Scale and Children's Emotional Indicator Scale (CEMS) will be completed and physiologic parameters will be recorded (pre-procedure). Routine tests will be performed by equipped nurses on the inner side of the forearm, 5 cm from the wrist and 3 cm from the antecubital fossa, in the skin area with intact skin integrity. After the procedure, CEMS and FLACC Pain Scale will be filled again and physiologic parameters will be recorded.

Animal-assisted therapy: fish in a fishbowl and the red fish song

EXPERIMENTAL

In the intervention group, the Personal Information Form, FLACC pain scale, and Children's Emotional Indicator Scale (CEMS) will be completed and physiologic parameters will be recorded (pre-procedure). Children will be allowed to communicate with fish before the procedure starts. During the procedure, the tests will be performed by equipped nurses on the inner side of the forearm, 5 cm from the wrist and 3 cm from the antecubital fossa, in the skin area with intact skin integrity, with the betta fish still next to it. After the procedure, CEMS and FLACC pain scale will be filled again and physiologic parameters will be recorded.

Behavioral: animal assisted therapy

Interventions

animal assisted therapy BEHAVIORAL

The 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.

Animal-assisted therapy: fish in a fishbowl and the red fish song

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• No previous allergy testing
• years old
• Stable hemodynamics
• No chronic disease
• The child has no intellectual or neurological disability
• The mother has no obstacle to communication
• Mother is literate
• Families and children agree to participate in the study.

You may not qualify if:

• Child's and mother's unwillingness to participate in the study

Sponsors & Collaborators

• Mehtap METİN KARAASLAN: lead

Related Publications (4)

• Yazici S, Gunes S, Kurtulus-Cokboz M, Kemer O, Baranli G, Asik-Akman S, Can D. Allergen variability and house dust mite sensitivity in pre-school children with allergic complaints. Turk J Pediatr. 2018;60(1):41-49. doi: 10.24953/turkjped.2018.01.006.

  PMID: 30102478 BACKGROUND

• Bains P, Dogra A. Skin prick test in patients with chronic allergic skin disorders. Indian J Dermatol. 2015 Mar-Apr;60(2):159-64. doi: 10.4103/0019-5154.152513.

  PMID: 25814704 BACKGROUND

• Erdim L. The effect on pain and anxiety levels of using DistrACTION(R) Cards to distract children during a skin-prick test: a randomized controlled experimental study. Minerva Pediatr (Torino). 2022 Apr;74(2):167-175. doi: 10.23736/S2724-5276.21.06008-0. Epub 2021 Apr 2.

  PMID: 33820412 BACKGROUND

• Karaatmaca B, Sahiner UM, Soyer O, Sekerel BE. The impact of skin prick testing on pain perception and anxiety in children and parents. Allergol Immunopathol (Madr). 2021 Mar 1;49(2):72-79. doi: 10.15586/aei.v49i2.68. eCollection 2021.

  PMID: 33641297 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ASSIST. PROF.

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 14, 2025
• Study Start: April 1, 2025
• Primary Completion: January 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-03