RecruitingRecruiting
Using a Stress Ball on Fear, Anxiety, Pain, and Satisfaction During Allergy Testing
NCT07750236 · Tarsus University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
The Effect of Watching Cartoons and Using a Stress Ball on Fear, Anxiety, Pain, and Satisfaction During Allergy Testing in Children
About this study
This study proposal outlines a randomized controlled trial (RCT) designed to investigate the effects of two non-pharmacological distraction techniques-watching cartoons and using a stress ball-on fear, anxiety, pain, and satisfaction levels in children aged 4 to 10 undergoing skin prick allergy testing at the Pediatric Allergy Outpatient Clinic of Çukurova University Balcalı Hospital between August 2026 and June 2027. A sample of 90 children undergoing their first allergy test without physical, visual, auditory, or cognitive impairments will be recruited based on power analysis calculations and randomly assigned via a computer program into three equal groups of 30: a cartoon-watching group, a stress ball group, and a control group receiving standard care with parent presence. The primary objective is to test the hypotheses ($H\_1$ and $H\_2$) that active or passive distraction significantly reduces procedural distress and enhances satisfaction, against the null hypothesis ($H\_0$) of no effect. Data will be gathered using a Demographic Information Form, the Children's Fear Scale (CFS), the Children's Anxiety Scale-State (CAS-S), the Wong-Baker FACES Pain Rating Scale, and a Child Satisfaction Form. Assessments will be reported by the child, parent, and observer nurse at three specific timeline stages: 2 minutes prior to the test, immediately following the procedure while the child is in the procedure chair, and 15 minutes post-procedure during the evaluation of skin reactions. Ultimately, this research aims to establish evidence-based nursing interventions to improve pediatric comfort during invasive diagnostic procedures, with target outputs including presentations at national and international conferences and publication in SCI/SCI-Expanded indexed journals.
Eligibility criteria
Inclusion Criteria:
* Aged 4-10 years
* Undergoing an allergy test for the first time
* Voluntary participation by both the child and the parent
Exclusion Criteria:
* The child must not have taken any medication prior to the skin test
* The child must have a visual, hearing, or intellectual disability
* The child must have a physical condition that would prevent them from using the stress ball
Study design
Enrollment target: 90 participants
Allocation: randomized
Masking: none
Age groups: child
Timeline
Starts: 2026-08-10
Estimated completion: 2027-05-10
Last updated: 2026-08-11
Interventions
Other: cartoon-watching groupOther: stress ball group
Primary outcomes
- • anxiety level (1 hour)
- • fear level (1 hour)
- • pain level (1 hour)
Sponsor
Tarsus University · other
Contacts & investigators
ContactAtiye KARAKUL · contact · atiyekarakul@tarsus.edu.tr · 903246000033
All locations (1)
Tarsus UniversityRecruiting
Tarsus, Turkey (Türkiye)