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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03835390
SIMDiscovery: The Benefits of Utilizing a Simulation Preparation Program for Spinal Fusion Surgery
3 de septiembre de 2020 actualizado por: Daniel Hedequist, Boston Children's Hospital
SIMDiscovery: The Benefits of Utilizing a Preparation Program With Simulation in Reducing Anxiety and Increasing Preparedness Among Parents and Their Children Undergoing Spinal Fusion Surgery
This is a pilot study aiming to examine preliminary effectiveness of a preparation program which includes simulation (SIMDiscovery) in reducing anxiety and increasing feelings of preparedness among parents and their children who will undergo spinal fusion surgery.
SIMDiscovery is an experiential learning preparation program which aims to educate children and families about different medical procedures through simulation play.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
22
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.
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Boston Children's Hospital
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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
10 años a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Children and adolescents with adolescent idiopathic scoliosis and their parent(s)
- Spinal fusion surgery scheduled
- Developmental Age range (10+; no upper age range)
- Males and females of all races and ethnicities
- English-speaking families (although English need not be their primary language)
- Both patient and caregiver (when patient is under 18 years of age) are able to attend SIMDiscovery program
Exclusion Criteria:
- - Other significant chronic medical conditions (e.g., spina bifida, muscular dystrophy)
- Anterior surgical access
- ICU stay expected post-op
- Cognitive functioning level below 10yo
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intervention
Participants who agree to participate in the SIMDiscovery program will be asked if they would like to participate in the research.
If they consent, they will fill out pre- and post-questionnaires concerning quality of life, anxiety levels concerning the surgery, and a knowledge assessment.
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The SIMDiscovery program consists of nine stations that were designed to mirror the different stages of the perioperative process.
The stations mirror the different stages of the surgical process and provide patients and their families with education regarding what they can anticipate during each aspect of the intervention.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from Parent's and Adolescent's Baseline Anxiety at 1 month using the State/Trait Anxiety Inventory
Periodo de tiempo: Baseline, 1 month
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Parent and adolescent anxiety will be measured at baseline utilizing the State/Trait Anxiety Inventory (STAI) (Spielberger et al., 1983).
The STAI consists of 40 items total-20 items assessing trait anxiety (general proneness to anxious behavior) and 20 items assessing state anxiety (a current emotional state).
All items are scored using a four-point scale (e.g., ranging from "Almost Never" to "Almost Always").
Scores can range from 20 to 80 with higher scores indicating greater anxiety.
This measure has been validated for use with individuals ages 15 and above (Julian, 2011).
If a patient is 15 years of age or above, they will complete the STAI, rather than the STAIC (see below).
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Baseline, 1 month
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Change from Child's Baseline Anxiety at 1 month using the State/Trait Anxiety Inventory for Children
Periodo de tiempo: Baseline, 1 month
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Child anxiety will be assessed utilizing the State/Trait Anxiety Inventory for Children (STAIC) (Spielberger & Edwards, 1973).
Similar to the STAI, the STAIC consists of 20 items assessing state anxiety and 20 items assessing trait anxiety.
Items are scored using a four-point scale and higher scores indicate greater anxiety.
The STAIC has been validated for use with children up to age 15 years (Spielberger & Edwards, 1973).
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Baseline, 1 month
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Change from Parent's Baseline Feelings of Preparedness at 1 month using Caregiver Preparedness Scale
Periodo de tiempo: Baseline, 1 month
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Parent preparedness will be measured using the Caregiver Preparedness Scale (CPS) (Archbold, et al., 1990).
This scale has been validated for use with adult caregivers (Petruzzo et al., 2017; Pucciarelli et al., 2014).
The CPS includes eight items assessing caregiver preparedness to care for a patient's physical and emotional needs, setting up services, coping with the stress of caregiving, making caregiving activities pleasant for the caregiver and patient, responding and managing emergencies, obtaining assistance from the health care system, and overall preparedness.
Each item is rated from 0 (not at all prepared) to 4 (Very well prepared).
Items are summed for a total score that ranges from 0 to 32, with higher scores indicating feeling better prepared for the caregiving role.
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Baseline, 1 month
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Change from Child's Baseline Feelings of Preparedness at 1 month using a modified Caregiver Preparedness Scale
Periodo de tiempo: Baseline, 1 month
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In order to examine themes similar to parent preparedness but from the patient's perspective, we will administer a measure similar to the CPS (above) for children and adolescent patients.
This measure has not been validated; rather, based on the validity of the CPS used to assess parent preparedness, we modified the measure to assess patients' perception of their ability to care for or advocate for themselves regarding their physical and emotional needs prior to the surgery.
(Archbold, et al., 1990).
All patients will complete this measure.
This measure consists of six questions and similar to the CPS, each item is rated from 0 (not at all prepared) to 4 (Very well prepared).
Items are summed for a total score that ranges from 0 to 24, with higher scores indicating more feelings of preparedness for the surgery.
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Baseline, 1 month
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Knowledge of Perioperative Procedures measured by Spinal Fusion Knowledge Assessment
Periodo de tiempo: Baseline, 1 month
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Facts that patients learn through the preoperative appointment and the SIMDiscovery program measured by the Spine Fusion Knowledge Assessment developed by our team
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Baseline, 1 month
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Daniel Hedequist, MD, Boston Children's Hospital
- Investigador principal: Lauren Potthoff, PhD, Boston Children's Hospital
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 (Actual)
22 de febrero de 2019
Finalización primaria (Actual)
9 de septiembre de 2019
Finalización del estudio (Actual)
1 de octubre de 2019
Fechas de registro del estudio
Enviado por primera vez
5 de febrero de 2019
Primero enviado que cumplió con los criterios de control de calidad
6 de febrero de 2019
Publicado por primera vez (Actual)
8 de febrero de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de septiembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
3 de septiembre de 2020
Última verificación
1 de septiembre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB-P00030717
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
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