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

7 de agosto de 2026 actualizado por: Duygu Sonmez Duzkaya, Tarsus University
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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

  1. 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.
  2. 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.
  3. 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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

174

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Fatma Nom

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

Sí

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
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.
Experimental: 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.
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.
Sin intervención: Control Group
Children in the control group will not be subjected to any distracting interventions; they will receive only routine clinical care.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Fear Scale
Periodo de tiempo: 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)
1 day
Informative Questionnaire
Periodo de tiempo: 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.
1 day
Pencil Pain Scale
Periodo de tiempo: 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
1 day

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Child Satisfaction Form
Periodo de tiempo: 1 day
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.
1 day

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

10 de febrero de 2027

Finalización del estudio (Estimado)

1 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

3 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

7 de agosto de 2026

Publicado por primera vez (Actual)

10 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 2026/08

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .