Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

The Effect of a Riddle-Based Distraction Technique on Pain, Fear, and Anxiety During Cast Application in Children: A Randomized Study

22 de septiembre de 2026 actualizado por: Gamze Akay, Artvin Coruh University

The aim of this study is to determine the effect of a riddle-based distraction intervention, administered during cast application in children, on levels of pain, fear, and anxiety.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Thirty-eight volunteer children aged 6-12 presenting to the Emergency Department Green Zone Cast Room at hospital for cast application (upper or lower extremity) will be randomly divided into two groups: intervention (riddle-based distraction) and control group. Children will be assessed before and during/after the procedure. Pain related to the cast application will be assessed with the Wong-Baker Faces Pain Scale, fear with the Child Fear Scale, and anxiety levels with the State-Trait Anxiety Inventory for Children (STAIC). In addition, children's sociodemographic and clinical data will be recorded in the Information Form.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

68

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

Ubicaciones de estudio

    • Central
      • Kilis, Central, Turquía (Türkiye)
        • Reclutamiento
        • Kilis Prof. Dr. Alaeddin Yavaşca State Hospital
        • Contacto:

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

6 años a 12 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Being between 6 and 12 years of age
  • Scheduled for cast application (upper or lower extremity)
  • Conscious and able to communicate
  • Able to understand and speak Turkish
  • Having no auditory or cognitive impairments
  • Having no prior exposure to a similar non-pharmacological distraction intervention
  • Willingness of both the child and parent to participate in the study

Exclusion Criteria:

  • Being under the influence of analgesic, sedative, or anxiolytic medication
  • Having severe trauma or an unstable clinical condition requiring emergency intervention
  • Presence of developmental delay, neurological disease, or conditions affecting communication
  • Inability to participate in riddles due to hearing or visual impairment
  • Having prior cast experience on the same extremity
  • Inability to cooperate during the research process

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control Group

Routine clinical care will be applied to the control group. No action will be taken.

Experimental: Experimental Group

Before and during the cast application, the child will be asked age-appropriate simple riddles, encouraged to actively participate through clues, and their attention will be distracted from the procedure.

Children who come to the hospital's cast room and meet the research criteria will be randomly assigned to the intervention group. The baseline scales and information forms will be filled out by the researcher through interviews with the child and parent before the cast application. Before the research, a pool of short, clear, and age-appropriate riddles will be prepared in consultation with experts, taking into account the cognitive levels of children aged 6-12. Prior to the procedure, brief communication will be established with the child to introduce the riddle game. During the cast preparation (preparing materials and positioning the extremity) and throughout the entire cast application process (wrapping, shaping, and setting the cast), the researcher will continuously ask the child riddles. The child's active participation will be encouraged by providing hints when needed and offering positive feedback. Active distraction turns the frightening cast room into an engaging space.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient Identification Form
Periodo de tiempo: Baseline

It is a form consisting of 4 questions in total, including the child's age, gender, previous fracture experience, and if any, how many times the child has experienced a fracture. It was prepared by the researcher in accordance with the literature.

Baseline
Wong-Baker FACES Pain Rating Scale
Periodo de tiempo: Baseline and up to 4 weeks

This scale was developed by Donna Wong and Connie Moran Baker in 1981 to assess pain levels in children. Suitable for children aged 3-18 years, the scale consists of 6 facial expressions scored from '0' to '10'. A score of "0" indicates no pain, while a score of "10" represents the worst possible pain. In our study, the child will be shown the facial expressions on the scale, asked to choose the face that best describes their pain, and the corresponding score will be recorded.

Baseline and up to 4 weeks
Child Fear Scale - CFS
Periodo de tiempo: Baseline and up to 4 weeks

Developed by McMurtry and colleagues, the Turkish validity of this scale was conducted by Gerçeker and colleagues. The changes in the facial muscles of a frightened expression were drawn by a graphic artist from a photograph of a frightened face. The scale features facial expressions scored from 0 to 4, where "0" indicates a neutral expression (no fear), "1" indicates a very low level of fear, "2" indicates a little fear, "3" indicates a greater level of fear, and "4" indicates the highest level of fear. In our study, the child will be shown the facial expressions on the fear scale, asked to select how they feel, and the corresponding score will be recorded.

Baseline and up to 4 weeks
State-Trait Anxiety Inventory for Children - STAIC / Thermometer
Periodo de tiempo: Baseline and up to 4 weeks

Developed to measure anxiety in children, the Turkish validity of this tool was confirmed by Gerçeker and colleagues (Ayar et al.). The scale utilizes a thermometer visual with a bulb at the bottom representing a score of "0" and lines extending upwards divided into 10 sections reaching a score of "10". The child is explained that as their finger moves up from the bulb, their anxiety increases, whereas the bulb represents playing happily with friends. In our study, the child will be asked to point to the thermometer according to how they feel during the procedure, and the corresponding score will be recorded.

Baseline and up to 4 weeks

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Gamze AKAY, 1, Artvin Coruh University

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.

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 noviembre de 2026

Finalización primaria (Estimado)

1 de febrero de 2027

Finalización del estudio (Estimado)

1 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

22 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de septiembre de 2026

Publicado por primera vez (Actual)

28 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de septiembre de 2026

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

22 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Riddle-Based in Children

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .