- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05934435
Alivio empoderado brindado por enfermeras (ERA)
Abordar las desigualdades en la atención del dolor con el alivio empoderado brindado por enfermeras de ASPMN: un ensayo controlado aleatorio
This study will investigate effects of a psychoeducation pain management skills intervention on adults with persistent pain by training a cohort of American Society for Pain Management Nursing (ASPMN) nurses to deliver and it [Empowered Relief (ER)], as a single-session video-conferenced program. The primary objective is to evaluate the effects of ASPMN nurse-provided ER versus waitlist control (WLC) on pain catastrophizing, pain bothersomeness, pain intensity, pain interference, sleep disturbance, physical function, depression, anxiety, and social isolation for patients with persistent pain. Secondarily, feasibility and acceptability of the ER program will be assessed through recruitment and retention data and qualitative satisfaction data.
Descripción general del estudio
Descripción detallada
Design: This study will be conducted as a randomized controlled trial comparing effects of ER to a WLC of participants with persistent pain when ER is provided by ER-trained ASPMN nurses. The secondary aims of feasibility and acceptability will use qualitative descriptive methods.
Participants: Participants (N=170) will be adults aged 18 and above years with self- reported or clinically diagnosed persistent pain. Participants will be recruited at clinical sites identified by ER-trained nurses and can be self or clinician referred. Participants will complete an online eligibility form to screen for inclusion and exclusion criteria. Inclusion criteria: pain >3 months more than half the time, English fluency, ability to attend a one-time web-based class and complete web-based surveys, age > 18 years. Exclusion criteria: Previous participation in ER class, cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material or full participation in the study as determined by the investigators.
Procedures: Twenty ASPMN nurses will receive ER training facilitated by Stanford Pain Relief Innovations Lab. ER- trained nurse providers will be ASPMN-member nurses of any clinical background. ASPMN nurses will be invited to apply to become a trainer with the following expectations: ability to fully participate in a live, online, 2-day ER instructor training, able to fluently complete instructor training and deliver the ER program in English, commitment to deliver 1-3 live, online, 2-hour ER programs for patient participants, and willingness to complete post-program surveys after each session they deliver reporting on number of participants and any barriers encountered. Recruitment will occur through ASPMN-related mechanisms of communication, including its website, national officers and directors, newsletter, research group, national committees, chapter leadership and listserv.
After meeting eligibility criteria and completing informed consent, study participants will be asked to complete a baseline survey of demographics and health variables (as outlined in Table 1) and then randomized 1:1 to one of two unblinded study groups: ER and WLC. Participants randomized to the ER group will complete a HIPAA compliant, password protected Zoom ER class delivered by an ER-trained ASPMN nurse. A crossover intervention class will be offered to those patient participants randomized to WLC once the ER group has completed their class and follow up assessments, estimated at 2 months post intervention.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Washington
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Spokane, Washington, Estados Unidos, 99201
- Washington State University
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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 > 18 years
- pain >3 months more than half the time
- English fluency
- ability to attend a one-time web-based class and complete web-based surveys.
Exclusion criteria:
- Previous participation in ER class
- cognitive impairment
- non-English speaking
- psychological factors that would preclude comprehension of material or full participation in the study as determined by the investigators.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Empowered Relief treatment
Participants randomized to the ER group will complete a HIPAA compliant, password protected 2-hour Zoom ER class delivered by an ER-trained ASPMN nurse. |
psycho-educational pain skills training
Otros nombres:
|
|
Otro: Wait-list Control
Participants randomized to the Wait-list Control group will continue their usual pain care for 2 months and complete surveys to compare with the experimental treatment group. After serving as controls, they will be invited to attend the 2-hour Zoom ER class delivered by an ER-trained ASPMN nurse. |
psycho-educational pain skills training
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain Catastrophizing
Periodo de tiempo: Participants will be assessed at baseline, and then at 2, 4, and 8 week timepoints for change over time.
|
Measured by self-report on Pain Catastrophizing Scale, a 13-item scale that uses a 5-point Likert scale (0 = not at all; 4 = all the time) to measure how often negative thoughts and feelings occur when experiencing pain. It is scored by summing all items for a total PCS score (range 0-52), with higher scores indicating more frequent pain-related catastrophic thoughts. |
Participants will be assessed at baseline, and then at 2, 4, and 8 week timepoints for change over time.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Pain Intensity
Periodo de tiempo: Participants will be assessed at baseline, and then at 2, 4, and 8 week timepoints for change over time.
|
0-10 Pain severity scale using PROMIS Pain Intensity short form 1a where average pain intensity over the previous seven days is self-reported using an 11-point Likert scale (0 = no pain; 10 = worst imaginable pain) where higher scores are worse outcomes. |
Participants will be assessed at baseline, and then at 2, 4, and 8 week timepoints for change over time.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Marian Wilson, PhD, Washington State University
Publicaciones y enlaces útiles
Enlaces Útiles
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
- 20013-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Can be requested from principal investigator
Marco de tiempo para compartir IPD
After publication
Criterios de acceso compartido de IPD
Use for secondary analysis
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Datos del estudio/Documentos
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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