Using a Stress Ball on Fear, Anxiety, Pain, and Satisfaction During Allergy Testing
10. august 2026 oppdatert av: Atiye Karakul, Tarsus University
The Effect of Watching Cartoons and Using a Stress Ball on Fear, Anxiety, Pain, and Satisfaction During Allergy Testing in Children
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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
90
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Atiye KARAKUL
- Telefonnummer: 2231 903246000033
- E-post: atiyekarakul@tarsus.edu.tr
Studiesteder
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Tarsus, Tyrkia (Türkiye)
- Rekruttering
- Tarsus University
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Ta kontakt med:
- Atiye Karakul Assoc. Prof., PhD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: cartoon-watching group
Children in this group will engage in passive distraction by watching cartoons.
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Children in this group will engage in passive distraction by watching cartoons.
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Eksperimentell: stress ball group
Children in this group will engage in active physical distraction by using a stress ball.
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Children in this group will engage in active physical distraction by using a stress ball.
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Ingen inngripen: control group
Children in this group will receive the standard clinical care provided by the outpatient clinic without any specific non-pharmacological distraction interventions.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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smertenivå
Tidsramme: 1 time
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Wong Baker Pain Scale: Den ble utviklet av Donna Wong og Connie Morain Baker i 1980 og tilpasset igjen i 1983 for å måle smertenivået til pediatriske pasienter.
Det er 6 ansiktsuttrykk skåret mellom 0-5.
I Wong-Baker-skalaen er det ansiktsuttrykk som indikerer graden av smerte som øker fra 0 til 5 fra venstre til høyre.
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1 time
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anxiety level
Tidsramme: 1 hour
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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.
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1 hour
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fear level
Tidsramme: 1 hour
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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.
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1 hour
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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satisfaction level
Tidsramme: 1 hour
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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.
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1 hour
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- NIAID-Sponsored Expert Panel; Boyce JA, Assa'ad A, Burks AW, Jones SM, Sampson HA, Wood RA, Plaut M, Cooper SF, Fenton MJ, Arshad SH, Bahna SL, Beck LA, Byrd-Bredbenner C, Camargo CA Jr, Eichenfield L, Furuta GT, Hanifin JM, Jones C, Kraft M, Levy BD, Lieberman P, Luccioli S, McCall KM, Schneider LC, Simon RA, Simons FE, Teach SJ, Yawn BP, Schwaninger JM. Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel. J Allergy Clin Immunol. 2010 Dec;126(6 Suppl):S1-58. doi: 10.1016/j.jaci.2010.10.007.
- Aguero CA, Sarraquigne MP, Parisi CAS, Marino AI, Lopez K, Menendez Porfirio B, Sasia L, Lozano A, Bovina Martijena MDP, Gervasoni ME, Bozzola M, Colella M, Saranz R, Orellana J, Maspero JF, Seisdedos V, Behrends I, Blanco A, Dayan P, Matta Ruffolo M, Araoz I, Casaniti C, Garcia J, Skrie V, Garcia M, Suarez Garcia JM, Orellano F, Luconi N, Bandin G. [Allergic rhinitis in pediatrics: recommendations for diagnosis and treatment]. Arch Argent Pediatr. 2023 Apr 1;121(2):e202202894. doi: 10.5546/aap.2022-02894. Spanish.
- Ansotegui IJ, Melioli G, Canonica GW, Caraballo L, Villa E, Ebisawa M, Passalacqua G, Savi E, Ebo D, Gomez RM, Luengo Sanchez O, Oppenheimer JJ, Jensen-Jarolim E, Fischer DA, Haahtela T, Antila M, Bousquet JJ, Cardona V, Chiang WC, Demoly PM, DuBuske LM, Ferrer Puga M, Gerth van Wijk R, Gonzalez Diaz SN, Gonzalez-Estrada A, Jares E, Kalpaklioglu AF, Kase Tanno L, Kowalski ML, Ledford DK, Monge Ortega OP, Morais Almeida M, Pfaar O, Poulsen LK, Pawankar R, Renz HE, Romano AG, Rosario Filho NA, Rosenwasser L, Sanchez Borges MA, Scala E, Senna GE, Sisul JC, Tang MLK, Thong BY, Valenta R, Wood RA, Zuberbier T. IgE allergy diagnostics and other relevant tests in allergy, a World Allergy Organization position paper. World Allergy Organ J. 2020 Feb 25;13(2):100080. doi: 10.1016/j.waojou.2019.100080. eCollection 2020 Feb.
- Chamani, S., Mahmoudzadeh, S., Rezapour, H., & Fereidouni, M. (2021). Frequency of allergic sensitivity to local herbs pollen among medical students in east of Iran by use of skin prick test. Alergia Astma Immunologia, 26(1), 27-35.
- Gurbuz F, Geckil E, Guner SN. The effect of virtual reality and buzzy(R) on pain, fear, and anxiety during skin prick testing in children: a randomized controlled trial. Eur J Pediatr. 2026 May 5;185(6):349. doi: 10.1007/s00431-026-07020-3.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. august 2026
Primær fullføring (Antatt)
10. april 2027
Studiet fullført (Antatt)
10. mai 2027
Datoer for studieregistrering
Først innsendt
1. august 2026
Først innsendt som oppfylte QC-kriteriene
1. august 2026
Først lagt ut (Faktiske)
6. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026/112
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