Examining Bluetooth Haptic Device Use for Pain and Distress Reduction in Vascular Access Procedures (VA+BHD)
Examining Bluetooth Haptic Device Use for Pain and Distress Reduction in Vascular Access Procedures (VA+BHD)
This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular access procedures.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
Palo Alto, California, Estados Unidos, 94304
- Lucile Packard Childrens Hospital Stanford
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Between age 4-99
- Will undergo a vascular access procedure
- English speaking participant and parent or LAR
Exclusion Criteria:
- Legal guardian not present to obtain consent
- Child is unable to self-report pain or anxiety
- Child with a significant neurological condition, or major developmental disability
- Child with active infection of the hand or arm
- Major surgery within the last 48 hours
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: BHD synced with mobile game
At the beginning of the vascular access procedure, the BHD will be applied 5 cm above the needle insertion site and maintained in place throughout the procedure. It delivers a constant low-frequency vibration as well as tactile feedback from the game (GF). |
The BHD delivers a constant low-frequency vibration as well as tactile feedback from the game (GF). |
|
Otro: BHD only
The participant will wear the BHD 5 cm above the needle insertion site for the duration of the procedure. The BHD will deliver constant low-frequency vibration (CF). |
The BHD will deliver constant low-frequency vibration (CF). |
|
Sin intervención: Standard of Care
The participant will not receive the BHD device. Participant will receive standard of care treatment. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
External observation for pain and anxiety using OBSD-r scale
Periodo de tiempo: during vascular access procedure
|
OBSD-r contains 8-item scale assessing participant's affective state; Information Seeking, Crying, Screaming, Restraint, Verbal Resistance, Emotional Support, Verbal Pain and Flail. |
during vascular access procedure
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
modified induction compliance checklist (mICC)
Periodo de tiempo: during vascular access procedure
|
The mICC score will be recorded by the trained research observers during the vascular access procedure. Perfect compliance (score of 0) was compared to those that lacked cooperation. mICC will be rated at the time of intervention and only requires one RA. |
during vascular access procedure
|
|
External observation for pain and anxiety using HRAD scale
Periodo de tiempo: during vascular access procedure
|
HRAD contains 5-item scale assessing participant's affective state; happy, relaxed, anxious, distressed, with a yes/no answer to cooperation. |
during vascular access procedure
|
|
Faces Pain Scale-Revised for patients aged 4-11
Periodo de tiempo: during vascular access procedure
|
Detailed qualitative review of cognitive interview probes with question-by-question analysis of transcribed cognitive interviews to assess for basic comprehension and appropriate use of the FPS-R. This scale is measured from 0-10, where 0 = no pain and 10 = very much pain. |
during vascular access procedure
|
|
Numerical Rating Pain Scale (NRPS) for patients aged 12-17
Periodo de tiempo: during vascular access procedure
|
NRPS is a 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain. |
during vascular access procedure
|
|
Self formulated procedural satisfaction survey (Healthcare provider)
Periodo de tiempo: immediately after vascular access procedure
|
The survey contains 5 items and utilizes a 5-point Likert agreement scale with a score of 1 meaning "completely disagree" and 5 meaning "completely agree." |
immediately after vascular access procedure
|
|
Self formulated procedural satisfaction survey (Patient and Parent)
Periodo de tiempo: immediately after vascular access procedure
|
The survey contains 10 items and utilizes a 5-point Likert agreement scale with a score of 1 meaning "completely disagree" and 5 meaning "completely agree." |
immediately after vascular access procedure
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Thomas Caruso, MD,PhD, Stanford University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- 73750
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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