- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07754136
The Effect of Using a Stress Ball and Watching Cartoons on Fear and Pain Levels During Enemas in Children Aged 6-12
연구 개요
상세 설명
Location and Time of the Study The study is planned to be conducted between September 2026 and May 2027 at the Pediatric Emergency Department of Mersin University Faculty of Medicine Hospital. The Pediatric Emergency Department consists of the following sections: Triage, Green Zone (6 beds), Yellow Zone (8 beds), Red/Critical Zone (3 beds), and Trauma Room (3 beds). The unit is staffed by 1 head nurse and 21 ward nurses. With an average of 220 patient visits per day, the most common reasons for presentation are fever, vomiting, diarrhea, abdominal pain, cough, respiratory distress, and trauma.
Research Variables Dependent variables: fear level, pain level Independent variables: use of a stress ball, showing cartoons
Data Collection The necessary ethics committee and institutional approvals will be obtained before the study begins. The study will be registered as a clinical trial. The study will include children aged 6-12 years who are undergoing enema procedures of the same type and volume at the Pediatric Emergency Department of Mersin University Faculty of Medicine Hospital and who meet the study's sample selection criteria. Children who do not meet the criteria will be excluded from the study. Procedures will be performed on children in all groups by the same nurse.
In line with the literature, researchers have identified distraction methods (cartoon content and the use of stress balls) appropriate for the developmental characteristics of children aged 6-12. To determine which cartoons will be used in the study, a pool of cartoons will be created by asking a total of ten children-five girls and five boys, aged 6-12-about their favorite cartoons. To evaluate the suitability of the cartoon pool, it will be presented to seven experts in the fields of child development, child psychiatry, and pediatric nursing to obtain their expert opinions. Children in Group 2 will use stress balls. The stress balls will be selected to be a size that children can easily grasp and of a soft texture. A pilot study involving 10 children will be conducted to evaluate the suitability of the data collection tools and distraction methods to be used in the study. The children included in the pilot study will not be included in the research sample. The children participating in the study and their parents will be informed about the purpose, content, and implementation process of the study. Written and verbal consent will be obtained from the parents, and verbal consent will be obtained from the children. All children participating in the study will receive routine clinical care.
Routine clinical procedure: Prior to the enema procedure, the child's vital signs are assessed, and the child is informed about the procedure using age-appropriate language.
The child is positioned appropriately (right or left lateral) and the parent is allowed to remain by the child's side during the procedure. During the procedure, the tip of the tube is lubricated and gently inserted into the rectal area, and the enema solution is administered. After the procedure, the child is monitored for potential complications. An informational consent form will be administered to the children included in the study prior to the procedure, and fear and pain levels will be assessed by the nurse, the parent, and the child. Children who meet the sample selection criteria will be randomized into three groups using a computer-generated random number generator.
- Cartoon-viewing group: In addition to standard clinical practice, children in the cartoon-viewing group will be shown an age-appropriate cartoon 1 minute before the procedure begins and will be encouraged to continue watching throughout the procedure.
- Stress ball group: In addition to the standard clinical routine, children in the stress ball group will be given a stress ball 1 minute before the procedure begins and will be encouraged to use it throughout the procedure.
- Control group: No distraction interventions will be applied to children in the control group; only standard clinical care will be provided.
The levels of fear and pain among children in all groups will be assessed immediately after the procedure is completed (before the child gets up from the dental chair). In addition, the satisfaction levels of children in the intervention groups will be assessed. The data collected will be analyzed using statistical methods, and the results will be reported.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Duygu SÖNMEZ DÜZKAYA, PhD
- 전화번호: 2200 ++903246000033
- 이메일: duygusduzkaya@tarsus.edu.tr
연구 연락처 백업
- 이름: Fatma Nom
연구 장소
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Mersin, 터키 (Türkiye), 33400
- Tarsus University
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연락하다:
- Duygu SÖNMEZ DÜZKAYA, PhD
- 전화번호: 2200 ++903246000033
- 이메일: duygusduzkaya@tarsus.edu.tr
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Children must:
- Be undergoing their first enema procedure
- Be 6-12 years
- Speak Turkish
- Have no communication difficulties
- Both the child and the parent must be willing to participate in the study
Exclusion Criteria:
- The patient has a high fever (above 38.3)
- The child has a visual, hearing, intellectual, or physical disability
- The child has genetic-metabolic or chronic diseases
- A parent has an intellectual disability
- Administration of analgesics or sedatives prior to the procedure
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Cartoon-Watching Group
In addition to the standard clinical procedures, children in the cartoon-viewing group will be shown an age-appropriate cartoon one minute before the procedure begins, and they will be encouraged to continue watching it throughout the procedure.
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In addition to the standard clinical procedure, children in the cartoon-watching group will be shown an age-appropriate cartoon one minute before the procedure begins, and they will be encouraged to continue watching it throughout the procedure.
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실험적: Stress ball group
In addition to the standard clinical procedure, children in the stress ball group will be given a stress ball 1 minute before the procedure begins and will be encouraged to use it throughout the procedure.
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In addition to the standard clinical procedure, children in the stress ball group will be given a stress ball 1 minute before the procedure begins and will be encouraged to use it throughout the procedure.
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간섭 없음: Control Group
Children in the control group will not be subjected to any distracting interventions; they will receive only routine clinical care.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fear Scale
기간: 1 day
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The scale was developed by Thurillet et al. (2022) to assess children's fears based on self-reports from children aged 4-12.
The Turkish validity and reliability study was conducted by Tavşan et al. (2024).
The scale consists of 600 facial expressions.
The scale rates fear on a scale ranging from 0 to 10 (graded in increments of two), consistent with pain rating scales.
The scale's content validity index and item content validity index values were found to be 0.98.
A very good level of statistically significant agreement was found between the Fear Scale and the Children's Fear Scale (Kappa = 0.878; p = 0.001)
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1 day
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Informative Questionnaire
기간: 1 day
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The informative questionnaire, developed in accordance with the literature, consists of questions regarding the sociodemographic characteristics and health history of children and comprises a total of 20 questions (Padir, 2023; Düdükcü & Padir, 2025).
This form will be developed by researchers.
Once permission has been obtained from the children and their parents who meet the inclusion criteria, this form will be completed by the nurse.
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1 day
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Pencil Pain Scale
기간: 1 day
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The Pencil Pain Scale is a valid and reliable measurement tool developed to assess pain levels in children aged 6-12.
The scale was developed by Güdücü Tüfekçi and Beyaz.
On the scale, a 5-cm line on the pencil illustration is graded from "0" to "5."
The "0" mark at the tip of the pencil indicates "no pain," while the "5" mark near the base indicates "unbearable pain."
A higher score on the scale indicates an increase in the intensity of the pain the child is experiencing.
The Pencil Pain Scale can be used both based on children's self-reports and by an observer (Güdücü Tüfekçi and Beyaz, 2018).
The Pencil Pain Scale is a single-item, one-dimensional physical pain measurement tool shaped like a pencil, Because it is a single-item tool designed to measure a single point of pain intensity rather than a multi-question questionnaire,a traditional Cronbach's alpha internal consistency test is typically not applicable or reported for it
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1 day
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Child Satisfaction Form
기간: 1 day
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The satisfaction assessment scale was developed based on the literature to ensure it is age-appropriate and easy for children to understand (Bozkul et al., 2024).
On the scale, scores ranging from 0 to 10 are arranged along a horizontal line, and children are asked to mark the score that best reflects their satisfaction with the education provided.
On the scale, a score of 0 indicates no satisfaction, while a score of 10 indicates the highest level of satisfaction.
To facilitate the assessment, visuals representing different levels of satisfaction have been added to the points corresponding to the scores.
ecause it is a single-item tool designed to measure a single point of pain intensity rather than a multi-question questionnaire, a traditional Cronbach's alpha internal consistency test is typically not applicable or reported for it.
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1 day
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Bozkul G, Karakul A, Duzkaya DS, Dilsen S. Effect of short film video and video-based education on fear, pain, and satisfaction of children undergoing day surgery. J Pediatr Nurs. 2024 Mar-Apr;75:49-56. doi: 10.1016/j.pedn.2023.11.029. Epub 2023 Dec 14.
- Timmerman MEW, Trzpis M, Broens PMA. Using laxatives and/or enemas to accelerate the diagnosis in children presenting with acute abdominal pain: a randomised controlled trial study protocol. BMJ Paediatr Open. 2018 Nov 9;2(1):e000341. doi: 10.1136/bmjpo-2018-000341. eCollection 2018.
- Thurillet S, Bahans C, Wood C, Bougnard S, Labrunie A, Messager V, Toniolo J, Beloni P, Fourcade L. Psychometric properties of a self-assessment fear scale in children aged 4 to 12 years. Scary Scale. J Pediatr Nurs. 2022 Jul-Aug;65:108-115. doi: 10.1016/j.pedn.2022.02.020. Epub 2022 Mar 14.
- Tavsan B, Uysal G, Semerci R. Psychometric Property Examination of a Self-Assessment Fear Scale in Turkish Children Aged 4-12 Years: A Methodological Study. Res Theory Nurs Pract. 2024 Apr 25;38(2):211-226. doi: 10.1891/RTNP-2023-0102.
- Hajehforoush, N. S., vd. (2024). Cartoons effect on pain and anxiety in children. Journal of Nursing and Midwifery Sciences, 11(1).
- Gündüz, S., Yüksel, S., Aydeniz, G. E., Aydoğan, R. N., Türksoy, H., Dikme, İ. B., & Efendiler, İ. (2016). Çocuklarda hastane korkusunu etkileyen faktörler. Çocuk Sağlığı ve Hastalıkları Dergisi, 59(4), 161-168.
- Düdükcü, F. T., & Padir, Z. (2025). Çocuklarda lavman öncesi ve sonrası korku, ağrı ve kaygı: Tanımlayıcı kesitsel çalışma [Yayımlanmamış çalışma]. Pamukkale Üniversitesi Sağlık Bilimleri Enstitüsü.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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