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NCT Number: NCT07750236

Using a Stress Ball on Fear, Anxiety, Pain, and Satisfaction During Allergy Testing

This randomized controlled trial aims to evaluate and compare the effects of watching cartoons and using a stress ball on levels of fear, anxiety, pain, and satisfaction among 90 children aged 4-10 undergoing skin prick testing at the Pediatric Allergy Outpatient Clinic of Çukurova University Balcalı Hospital. Participants will be randomly allocated via a computer algorithm into three equal groups ($n = 30$ each): a cartoon-watching intervention group, a stress ball intervention group, and a control group receiving routine pediatric care. Data will be gathered using a Demographic Information Form, the Children's Fear Scale, the Children's Anxiety Scale-State, the Wong-Baker FACES Pain Rating Scale, and a Child Satisfaction Form at three time points-2 minutes prior to the test, immediately after the procedure, and at the 15th-minute post-test evaluation-through child, parent, and observer nurse assessments.

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Key information

Conditions

Child Allergy Anxiety Anxiety Disorders Behavior Fear Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Personal Satisfaction Signs and Symptoms

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tarsus University

Tarsus, Turkey (Türkiye)

Location status: Recruiting

Location contact

Atiye Karakul Assoc. Prof., PhD

CONTACT

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

cartoon-watching group

Other

Children in this group will engage in passive distraction by watching cartoons.

Stress Ball Group

Other

Children in this group will engage in active physical distraction by using a stress ball.

Primary outcomes

  1. anxiety level

    Time frame: 1 hour

    Child Anxiety Scale-Dispositional Scale (CAS-D): It was developed by Ersig et al. (2013) to measure the anxiety levels of children aged 4-10 years. The CAS-D scale is shaped like a thermometer with a light bulb at the bottom and horizontal lines with intervals going upwards. In this scale for children aged 4-10 years, children are asked 'Imagine that all your anxious or nervous feelings are at the bulb or bottom of the thermometer' or 'If you are a little worried or nervous, the feelings may go up a little on the thermometer. If you are very, very anxious or nervous, emotions can go all the way to the top. Put a line on the thermometer showing how anxious or nervous you are'. In order to measure state anxiety (CAS-D), the child is asked to tick how he/she feels 'right now'. The score can range from 0-10.

  2. fear level

    Time frame: 1 hour

    Child Fear Scale: The scale was developed by Thurillet et al. It was developed to evaluate children's fears based on self-report of children aged 4-12 years. The scale consists of six facial expressions. The scale grades fear with a score ranging from 0 to 10 (gradually graded two by two) consistent with pain rating scales. The first facial expression shows that there is no fear, the fear increases as you go from right to left, and the sixth facial expression shows that the level of fear is the highest. A statistically significant positive and very high correlation was obtained between the Fear Scale and the Child Fear Scale (r=0.973; p;0.001). The high correlation value between the two forms shows that the child form is valid.

  3. pain level

    Time frame: 1 hour

    Wong Baker Pain Scale: It was developed by Donna Wong and Connie Morain Baker in 1980 and adapted again in 1983 to measure the pain levels of paediatric patients. There are 6 facial expressions scored between 0-5. In the Wong-Baker Scale, there are facial expressions indicating the degree of pain increasing from 0 to 5 from left to right.

Secondary outcomes

  1. satisfaction level

    Time frame: 1 hour

    The Child Satisfaction Scale was developed by researchers in line with the literature in a way that child patients can easily understand. The numbers between 0 and 10, which children will indicate by circling the point corresponding to their satisfaction with the education provided, are placed on a horizontal line. A score of 0 on the scale indicates "not satisfied at all" and a score of 10 indicates "extremely satisfied". In addition, there is a visual reflecting the degree of satisfaction in the places where the points are located.

Study contacts

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

Atiye KARAKUL

CONTACT

[email protected]

903246000033 ext. 2231

Sponsors and collaborators

Lead sponsor

Tarsus University

Other

Registry information

Official study title

The Effect of Watching Cartoons and Using a Stress Ball on Fear, Anxiety, Pain, and Satisfaction During Allergy Testing in Children

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2026
Registry last updated
Aug 6, 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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