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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое cartoon-watching group
  Children in this group will engage in passive distraction by watching cartoons.
• Другое stress ball group
  Children in this group will engage in active physical distraction by using a stress ball.

Первичные конечные точки

• anxiety level [Срок оценки: 1 hour]
• fear level [Срок оценки: 1 hour]
• pain level [Срок оценки: 1 hour]

Вторичные конечные точки (1)

• satisfaction level [Срок оценки: 1 hour]

Критерии участия

Критерии включения

• Aged 4-10 years
• Undergoing an allergy test for the first time
• Voluntary participation by both the child and the parent

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Tarsus University — Tarsus

Публикации

• 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: recommendation PMID 36924507
• 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 Ort PMID 32128023
• 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 managemen PMID 21134576
• 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.
• 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. PMID 33820412
• 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. PMID 42086773

Идентификаторы

NCT: NCT07750236 · 2026/112

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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