An interventional study of cartoon-watching group and stress ball group in Child Allergy, Anxiety and Fear, sponsored by Tarsus University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Tarsus University · Not applicable, Interventional, and Other
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.
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 90 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Tarsus University is the lead sponsor of 82 studies on the registry; 29 are open to participants now.
Compared within Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children in this group will engage in passive distraction by watching cartoons.
Other: cartoon-watching group
Children in this group will engage in active physical distraction by using a stress ball.
Other: stress ball group
Children in this group will receive the standard clinical care provided by the outpatient clinic without any specific non-pharmacological distraction interventions.
Children in this group will engage in passive distraction by watching cartoons.
Children in this group will engage in active physical distraction by using a stress ball.
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 hour
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 hour
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 hour
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 hour
Plan to share: Undecided
Started Aug 2026 (actual). Primary completion is estimated for Apr 2027, 8 months after the start.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 8 months is below that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tarsus University