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临床试验/NCT07754136
NCT07754136尚未招募不适用

The Effect of Using a Stress Ball and Watching Cartoons on Fear and Pain Levels During Enemas in Children Aged 6-12

Tarsus University1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
174
试验地点
1
主要终点
Fear Scale

研究概览

简要总结

Aim: The aim of this study is to investigate the effect of using a stress ball and watching cartoons during the enema procedure-performed as part of the diagnosis and treatment process-on the levels of fear and pain in children aged 6-12 who present to the pediatric emergency department with gastrointestinal (GI) complaints. Method: The study will be conducted between September 2026 and May 2027 at the Pediatric Emergency Unit of Mersin University Faculty of Medicine Hospital with children who are scheduled to undergo enema treatment. Children scheduled to receive enema treatment (a total of 174 children) will be divided into three groups (cartoon-viewing group: 58; stress ball group: 58; control group: 58). All children's vital signs will be assessed prior to the enema procedure. 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, parent, and child. In addition to the standard clinical procedure, children in the cartoon-watching group will be shown an age-appropriate cartoon 1 minute before the procedure begins. 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. No distraction techniques will be used for children in the control group.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Cartoon-Watching Group

Experimental

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.

干预措施: Cartoon watching group (Other)

Stress ball group

Experimental

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.

干预措施: Stress ball group (Other)

Control Group

No Intervention

Children in the control group will not be subjected to any distracting interventions; they will receive only routine clinical care.

结局指标

主要结局

Fear Scale

时间窗: 1 day

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)

Informative Questionnaire

时间窗: 1 day

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.

Pencil Pain Scale

时间窗: 1 day

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

次要结局

  • Child Satisfaction Form(1 day)

研究者

发起方
Tarsus University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Duygu Sonmez Duzkaya

Principal Investigator

Tarsus University

研究点 (1)

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