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Bookbased Emotion and Anxiety Reduction (BEAR)

3 de septiembre de 2026 actualizado por: Insel Gruppe AG, University Hospital Bern

Bookbased Emotion and Anxiety Reduction: A Children's Storybook Intervention to Reduce Preoperative Fear, a Single-center Prospective Randomized Controlled Trial

Many children are afraid of surgery and anesthesia. Studies show that up to 60% of children experience significant anxiety before a scheduled procedure. This fear is caused, for example, by the unfamiliar hospital environment, separation from parents, worry about pain, or because they do not know exactly what will happen. Severe anxiety before surgery can complicate the procedure and is linked to higher stress, increased post-operative pain perception, and behavioral changes. This study investigates whether a specially developed, age-appropriate children's book can help reduce anxiety before surgery. The book explains the anesthesia and surgical procedure in a child-friendly way using pictures and simple text. Children aged 4 to 10 who are undergoing surgery at the Inselspital Bern for an inguinal, umbilical, or ventral hernia can participate. A total of 50 children are to be included. The children will be randomly divided into two groups: One group receives the children's book to prepare at home. The other group receives the usual preparation without the book. The children's anxiety is measured using an established observation scale - once during the preliminary examination and again on the day of surgery before anesthesia. In addition, several contributing factors are recorded, such as how well the child cooperates during the induction of anesthesia or how much anesthetic medication is required. Parents will complete a short questionnaire regarding their own anxiety. Participation involves minimal risk. Only a children's book is provided, and the children's behavior is observed. No additional medical interventions are planned. The aim of the study is to test whether a simple, cost-effective, and easily implementable tool - a children's book - can effectively reduce anxiety before surgery. If the book proves to be helpful, it could be routinely used to prepare children for surgery in the future.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Background and Rationale:

Many children experience significant anxiety before scheduled surgical procedures. Literature indicates that up to 60% of pediatric patients exhibit substantial preoperative anxiety. This fear is primarily driven by an unfamiliar hospital environment, separation from parents, anticipation of pain, and a lack of understanding regarding the upcoming procedures. High levels of preoperative anxiety can complicate the clinical workflow, increase patient stress, elevate post-operative pain perception, and lead to negative postoperative behavioral changes. This study investigates whether a specially designed, age-appropriate children's book can effectively reduce preoperative anxiety. The educational book utilizes pictures and simplified language to explain the processes of anesthesia and surgery in a child-friendly manner.

Study Design and Objectives: This is a randomized controlled trial aiming to evaluate the efficacy of an educational children's book as a low-threshold intervention to mitigate preoperative anxiety in pediatric patients. The primary objective is to assess whether introducing this book during home preparation significantly decreases anxiety scores compared to standard care.

Participant Enrollment and Randomization: The study aims to enroll a total of 50 pediatric patients. Eligible participants are children aged 4 to 10 years scheduled for elective surgery (inguinal, umbilical, or ventral hernia repair) at the Inselspital Bern. Upon enrollment, participants will be randomly allocated into one of two parallel groups:

Intervention Group: Participants receive the specialized children's book for preoperative preparation at home.

Control Group: Participants receive standard preoperative preparation without the educational book.

Data Collection and Outcomes: Children's anxiety levels will be measured using an established, validated observational scale. Assessments will take place at two time points: during the initial preliminary outpatient examination (baseline) and on the day of surgery prior to the induction of anesthesia. Secondary outcomes and confounding variables will also be recorded, including:

The child's level of cooperation during the induction of anesthesia. The total dosage of anesthetic medication required. Parental anxiety levels, measured via a brief self-reported questionnaire.

Risk Assessment: Participation in this study carries minimal risk. The intervention consists solely of providing an educational book and observing standard clinical and behavioral outcomes. No additional medical interventions, invasive procedures, or alterations to the standard surgical protocol are involved.

Significance: If the intervention proves successful, this educational tool could be implemented into routine clinical practice to improve preoperative preparation and emotional well-being for pediatric surgical patients

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

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: Alexander Fuchs, PD Dr. med.
  • Número de teléfono: 0041316322384
  • Correo electrónico: alexander.fuchs@insel.ch

Ubicaciones de estudio

  • Suiza
    • Canton of Bern
      • Bern, Canton of Bern, Suiza, 3010
        • Children's Hospital, Inselspital, University Hospital Bern
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Viktoria A Pfeifle, Dr.med.

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

No

Descripción

Inclusion Criteria:

  • Children aged 4 to 10 years at the time of surgery
  • Scheduled for elective surgical intervention (inguinal hernia, umbilical hernia, epigastric or supraumbilical hernia)
  • Understanding of the German language
  • Written informed consent obtained from at least one parent or legal guardian

Exclusion Criteria:

  • Emergency surgical procedures
  • History of previous surgery
  • Less than 7 days between randomization and surgical procedure
  • Known developmental delay, cognitive impairment, or psychiatric disorder that may interfere with anxiety assessment

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Reading the book
Children receive a book preoperatively that they read together with their parents
Otro: Reading a childrens book to prepare for the surgery
A book that has been especially designed for this study, a children's story, that could prepare children before undergoing surgery will be handed out to the children and their caregivers. They should read it before surgery.
Comparador activo: Standard care
Children do not receive the book preoperatively
Otro: Standard Care (in control arm)
Children do not receive this book

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
modified Yale Preoperative Anxiety Scale
Periodo de tiempo: perioperative

Preoperative anxiety level on the day of surgery, measured using the modified Yale Preoperative Anxiety Scale (mYPAS), assessed prior to induction of anesthesia before administration of any sedative premedication.

The mYPAS Scale ranges from 23,33 (minimum) to 100 (maximum), with higher scores indicating greater preoperative anxiety. The scale comprises 22 items across 5 behavioral categories (activity, vocalization, emotional expressivity, state of apparent arousal, use of parents).
perioperative

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Baseline modified Yale Preoperative Anxiety Scale
Periodo de tiempo: Baseline
Baseline preoperative anxiety level measured using the modified Yale Preoperative Anxiety (mYPAS) scale prior to any study-related intervention. The mYPAS Scale ranges from 23,33 (minimum) to 100 (maximum), with higher scores indicating greater preoperative anxiety. The scale comprises 22 items across 5 behavioral categories (activity, vocalization, emotional expressivity, state of apparent arousal, use of parents).
Baseline
Anesthetic medication
Periodo de tiempo: perioperative
Amount of anesthetic medication used for induction of anesthesia, recorded from the anesthesia record. The amount of anesthetic medication used for induction will be analyzed descriptively and exploratorily; no causal inference is planned.
perioperative
Demographics
Periodo de tiempo: Baseline
Exploratory associations between preoperative anxiety and Age, Sex, Type of surgical procedure.
Baseline
Postoperative delirium
Periodo de tiempo: perioperative
Incidence of Postoperative delirium will be assessed in the post-anesthesia care unit using the Pediatric Anesthesia Emergence Delirium (PAED) scale by trained clinical staff and analyzed exploratorily. The PAED scale ranges from 0 (minimum) to 20 (maximum). Higher total scores indicate more severe emergence delirium.
perioperative
Parental anxiety
Periodo de tiempo: Baseline
Parental anxiety assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7) prior to intervention. The GAD-7 is a validated questionnaire widely used to quantify anxiety symptoms in adults. The GAD-7 ranges from 0 (minimum) to 21 (maximum). The higher the score, the more anxiety.
Baseline
Child compliance during induction (Induction Compliance Checklist)
Periodo de tiempo: perioperative
Child compliance during anesthesia induction, assessed using the Induction Compliance Checklist (ICC), a behavioral compliance scale during induction of anesthesia. This observational measure captures negative or non-compliant behaviors during anesthesia induction and provides complementary information on perioperative distress and cooperation. The Induction Compliance Checklist ranges from 0 (minimum) to 10 (maximum). Higher scores indicate poorer compliance during induction. Lower scores indicate better cooperation.
perioperative
Parental educational level and age
Periodo de tiempo: Baseline
Age of the parents and parental educational level, categorized according to the Swiss education system (primary, secondary I, secondary II, tertiary)
Baseline
Acceptability of the book intervention using a questionnaire
Periodo de tiempo: postoperative
Acceptability of the intervention assessed descriptively using parental feedback by using a questionnaire.
postoperative

Colaboradores e Investigadores

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

Patrocinador

Insel Gruppe AG, University Hospital Bern

Investigadores

  • Silla de estudio: Thomas Riva, Prof. Dr. med., Department of Anaesthesiology and Pain Medicine, Inselspital Bern, University Hospital, University of Bern

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 diciembre de 2027

Finalización del estudio (Estimado)

1 de abril de 2028

Fechas de registro del estudio

Enviado por primera vez

20 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de septiembre de 2026

Publicado por primera vez (Actual)

10 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2026

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

3 de septiembre de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • BEAR-trial

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. .

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