Impacto de los perros de terapia en la ansiedad y el comportamiento de los niños durante la anestesia local para procedimientos dentales
Impacto de los perros de terapia sobre la ansiedad y el comportamiento de pacientes dentales pediátricos durante la anestesia local: un ensayo controlado aleatorio
Therapy dogs in dental offices might help anxious children during dental care. Therapy dogs might help children during injection of local anesthetic, when we inject numbing medication before working on the teeth. The goal of this study is to learn if having a therapy dog with a child during the injection of numbing medication helps children to be more comfortable at the dentist's office. This study is of children who need dental care using local anesthesia. Study participant's behavioral reactions and heart rate during injection of local anesthetic with and without having a therapy dog present will be recorded and children and their guardians will be asked a few short questions about the injection and therapy dog after injection.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Children undergoing dental restorative or surgical procedures require injection of local anesthetic. The injection procedure is often the most anxiety-producing stimulus for children during dental care, when children demonstrate the highest level of emotional distress. Several studies have investigated various interventions, such as distraction, hypnosis, and cognitive behavioral therapy to ease this stress. Animal-assisted therapy (e.g. the presence of a therapy dog) may be a promising strategy for managing anxiety in young dental patients. However, no studies have explored the potential benefits of using therapy dogs specifically during the administration of local anesthesia in pediatric dental patients. The objective of this randomized controlled trial is to investigate the effects of therapy dogs on pediatric dental patients during local anesthesia administration.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: James R Boynton, DDS, MS
- Número de teléfono: 734-764-1523
- Correo electrónico: jboynton@umich.edu
Ubicaciones de estudio
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- Reclutamiento
- University of Michigan School of Dentistry Children's Clinic
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Contacto:
- James R Boynton, DDS, MS
- Número de teléfono: 734-764-1523
- Correo electrónico: jboynton@umich.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age range: children aged 4- to 12-years
- Health status: healthy children without significant medical conditions (ASA I or ASA II)
- Dental procedure: children scheduled for at least two dental procedures requiring local anesthesia
- Consent: written informed consent from the parent or legal guardian
- Verbal assent from potential subjects age 4-9 years; written assent for children age 10-12 years
Exclusion Criteria:
- Allergies: children with known allergies to dogs or animal dander
- Children with a fear or phobia of dogs
- Children with a behavioral disorder which may negatively impact response to the presence of a therapy dog
- Previous exposure: children who have previously undergone dental procedures with local anesthesia in the presence of a therapy dog
- Medical conditions: children with medical conditions that might affect their vital signs independently of the dental procedure (e.g., heart conditions)
- Parental discomfort: cases where parents are uncomfortable with the presence of a therapy dog during the procedure
- Advanced behavior guidance is indicated: children whose behavior for dental examination is classified as "Definitely Negative" (Frankl 1)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Control
Standard-of-care basic behavior guidance during local anesthesia |
Basic behavior guidance as defined by the American Academy of Pediatric Dentistry includes strategies to help children cope through potentially stressful dental procedures. These strategies include tell-show-do, positive reinforcement, parental presence, and nitrous oxide/oxygen analgesia, among others. |
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Experimental: Therapy dog presence
Therapy dog present during local anesthesia administration |
A trained therapy dog will be present during the child's dental appointment. The dog will be in the operatory as the child enters the room and will lie on the child during injection of local anesthesia. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Behavior (Face, Legs, Activity, Cry, and Consolability scale)
Periodo de tiempo: Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia
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The subject's behavior from entry into the operatory through one minute following administration of local anesthesia will be evaluated and recorded using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale, with each category scored from 0 to 2. The higher the total score, which ranges from 0 to 10, indicates more distress. |
Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Heart rate
Periodo de tiempo: Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia
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The subject's heart rate will be monitored and recorded every 30 seconds from entry into the operatory through one minute following administration of local anesthesia. |
Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia
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Anxiety assessment (Modified Faces version of the Modified Child Dental Anxiety scale)
Periodo de tiempo: Upon entering the operatory and after administration of local anesthesia
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The subject will be asked to complete an anxiety assessment using the revised modified faces version of the modified child dental anxiety scale (MCDASF). This questionnaire has two questions which are each answered on a five-point scale (range 1-5 for each question for a total range of 2-10). Higher values represent more distress. |
Upon entering the operatory and after administration of local anesthesia
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Parent questionnaire
Periodo de tiempo: Following injection of local anesthetic
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The subject's parent will be asked four questions regarding their child's anxiety and the therapy dog (if present). These four questions are not scaled. The questions are: Do you think your child was anxious for local anesthesia? Y/N; Do you think the therapy dog reduced your child's dental anxiety during local anesthesia? Yes/No; Would you want a therapy dog present for future dental treatment appointments? Yes/No; How do you think your child fees post-local anesthesia? Very Anxious/Anxious/Neutral/Calm/Very Calm. |
Following injection of local anesthetic
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: James R. Boynton, DDS, MS, University of Michigan
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HUM00260476
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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