Using a Stress Ball on Fear, Anxiety, Pain, and Satisfaction During Allergy Testing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-10
SponsorTarsus University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 4-10 years
Undergoing an allergy test for the first time
Voluntary participation by both the child and the parent
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
cartoon-watching group
Other interventionChildren in this group will engage in passive distraction by watching cartoons.
stress ball group
Other interventionChildren in this group will engage in active physical distraction by using a stress ball.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: cartoon-watching groupExperimental treatment 1 intervention
Group B: stress ball groupExperimental treatment 1 intervention
Group C: control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
anxiety level
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.
Time frame
1 hour2
fear level
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.
Time frame
1 hour3
pain level
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.
Time frame
1 hourSecondary outcomes
1
satisfaction level
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.
Time frame
1 hourSponsors and contacts
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Source ClinicalTrials.gov