- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT05934435
Alívio empoderado fornecido por enfermeiras (ERA)
Abordando as desigualdades no tratamento da dor com alívio capacitado fornecido por enfermeiras da ASPMN: um estudo controlado randomizado
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.
Visão geral do estudo
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Washington
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Spokane, Washington, Estados Unidos, 99201
- Washington State University
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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
Outros nomes:
|
|
Outro: 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
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain Catastrophizing
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Pain Intensity
Prazo: 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
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20013-001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Can be requested from principal investigator
Prazo de Compartilhamento de IPD
After publication
Critérios de acesso de compartilhamento IPD
Use for secondary analysis
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Dados/documentos do estudo
Informações sobre medicamentos e dispositivos, documentos de estudo
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