Using a Stress Ball on Fear, Anxiety, Pain, and Satisfaction During Allergy Testing
2026년 8월 10일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
90
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Atiye KARAKUL
- 전화번호: 2231 903246000033
- 이메일: atiyekarakul@tarsus.edu.tr
연구 장소
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Tarsus, 터키 (Türkiye)
- 모병
- Tarsus University
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연락하다:
- Atiye Karakul Assoc. Prof., PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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실험적: 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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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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통증 수준
기간: 1시간
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Wong Baker 통증 척도: 1980년 Donna Wong과 Connie Morain Baker가 개발했으며 1983년 소아 환자의 통증 수준을 측정하기 위해 다시 적용했습니다.
0~5점 사이의 6가지 표정이 있습니다.
Wong-Baker Scale에는 왼쪽에서 오른쪽으로 0에서 5까지 증가하는 통증 정도를 나타내는 얼굴 표정이 있습니다.
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1시간
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anxiety level
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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satisfaction level
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 8월 10일
기본 완료 (추정된)
2027년 4월 10일
연구 완료 (추정된)
2027년 5월 10일
연구 등록 날짜
최초 제출
2026년 8월 1일
QC 기준을 충족하는 최초 제출
2026년 8월 1일
처음 게시됨 (실제)
2026년 8월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 10일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .