Study to Understand Pain Experiences in Relationships (SUPER)
21 de abril de 2019 actualizado por: Angelia Corley, Wayne State University
Chronic pain is a highly prevalent and costly health care problem.
Yet, little is known about the optimal ways for health care providers and family members to respond to the distress expressed by people with chronic pain.
The aim of the current study is to compare two models of responsiveness to identify responses that result in better functioning and adjustment.
An experimental design will be used to test the extent to which emotional validation (e.g., an empathic response to distress) increases or decreases pain behaviors during physical activity.
Romantic partners of individuals with chronic pain will be randomly assigned to receive validation or control training.
Following training, people with chronic pain and their partners will engage in a discussion about pain and complete household tasks to examine the effects of partner training on communication, pain intensity, and pain behavior.
Additionally, each individual in the couple will complete self-report measures after the discussion, after the household tasks, and one-month following the laboratory visit.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
80
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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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Wayne State University's Relationships and Health Lab
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Romantic couples who are married or living with each other for 6 months or longer or have been in a romantic relationship 2+ years.
- One individual in the couple must have chronic muscoskeletal pain, lasting 3 months or longer. Participants may have multiple pain sites.
- The individual with chronic pain must report that their pain occurs nearly daily.
- The individual with chronic pain must have an average pain intensity of 3 or greater on an 11-point scale (from 0: no pain to 10: worst pain imaginable)
- The individual with chronic pain must have an average pain interference of 3 or greater on an 11-point scale (from 0: does not interfere to 10: completely interferes)
Exclusion Criteria:
- One or both individuals in the couple are unable to speak, read, or write in English.
- Both individuals in the couple have chronic pain. Couples may consist of one individual with chronic pain and one individual with "minimal pain", which we define as having some aspects of chronic pain but not all (e.g., has had nearly daily pain for 4 months but rates their pain below 3 in regards to interference and intensity)
- One or both individuals in the couple have widespread pain (e.g., fibromyalgia)
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: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Validation Training
In this arm, the romantic partner of the individual with chronic pain receives training on how to validate which is provided by the research assistant.
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In this intervention, romantic partners of individuals with chronic pain are trained individually by a research assistant.
The romantic partner is trained on how to validate the individual with chronic pain's pain-related distress and given education about validation.
This involves an approximately 45-minute brief, interactive training.
Otros nombres:
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Comparador de placebos: Education Training
In this arm, the romantic partner of the individual with chronic pain receives training on how to ask questions about treatments, which is provided by the research assistant.
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In this intervention, romantic partners of individuals with chronic pain are trained individually by a research assistant.
The romantic partner is trained on how to ask health professionals questions about treatment options and given health education about chronic pain.
This involves an approximately 45-minute brief, interactive training.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain Behavior (Behavioral coding)
Periodo de tiempo: During lab visit, during household tasks conducted in the laboratory, approx. 15 - 35 mins. after partner training (intervention)
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Pain behaviors (e.g., grimacing, guarding) measured with behavioral coding conducted by research assistants.
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During lab visit, during household tasks conducted in the laboratory, approx. 15 - 35 mins. after partner training (intervention)
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Pain Intensity (0 - 10 self-report rating scale)
Periodo de tiempo: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
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The individual with chronic pain will be asked to report on the pain they experienced during the discussion with their partner, controlling for their baseline pain rating at the beginning of their laboratory visit.
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During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
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Pain Intensity (0 - 10 self-report rating scale)
Periodo de tiempo: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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The individual with chronic pain will be asked to report on the pain they experienced during each household task (e.g., making a bed), controlling for baseline pain rating at the beginning of their laboratory visit.
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During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Number of Partner Validating Responses (Behavioral coding)
Periodo de tiempo: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
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Validating responses will be coded by research assistants.
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During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
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Number of Partner Invalidating Responses (Behavioral coding)
Periodo de tiempo: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
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Invalidating responses will be coded by research assistants.
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During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
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Pain-Related Emotional Disclosures (Behavioral coding)
Periodo de tiempo: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Behavioral coding by research assistants, accounting for activity level during household tasks.
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During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Number of Partner Validating Responses (Behavioral coding)
Periodo de tiempo: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Validating responses will be coded by research assistants
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During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Number of Partner Invalidating Responses (Behavioral coding)
Periodo de tiempo: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Invalidating responses will be coded by research assistants
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During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Partner Instrumental support (Behavioral coding)
Periodo de tiempo: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Partner instrumental support includes number of offers of assistance, acts of assistance, and behaviors that discourage physical activity, which will be measured by behavioral coding by research assistants
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During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Individual with Chronic Pain Assistance Behavior (Behavioral coding)
Periodo de tiempo: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Includes requests for assistance and accepting assistance, as measured by behavioral coding conducted by a research assistant
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During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Relationship Satisfaction (Questionnaire)
Periodo de tiempo: 1-month after the intervention
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Couples Satisfaction Index, Funk & Rogge, 2007.
Both partners' self-reports of relationship satisfaction.
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1-month after the intervention
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Interpersonal Closeness (Questionnaire)
Periodo de tiempo: During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
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Inclusion of Other in Self Scale, Aron, Aron, & Smollan, 1992.
Both partners' self-reports of interpersonal closeness.
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During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
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Perceived Partner Responsiveness (Questionnaire)
Periodo de tiempo: During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
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Reis et al., 2003.Both partners' self-reports on Perceived Partner Responsiveness.
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During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
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Pain Intensity (Questionnaire)
Periodo de tiempo: 1-month after the intervention
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Brief Pain Inventory, Cleeland, 1992.
The individual with chronic pain reports on their pain intensity using a 0 - 10 self-report scale, and indicates their average pain intensity over the last 24 hours.
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1-month after the intervention
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Accuracy of Estimate of Individual with Chronic Pain's Pain Intensity
Periodo de tiempo: During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
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Romantic partner will be asked to estimate the individual with chronic pain's average pain intensity, which will be compared to the individual with chronic pain's report to assess accuracy.
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During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
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Close other responses to pain and partner support (Questionnaire)
Periodo de tiempo: 1-month after the intervention
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West Haven-Yale Multidimensional Pain Inventory, Kerns, Turk, & Rudy, 1985.
Both partners' reports of partner responses to pain and partner support, i.e., self-report for the partner, and other-report for the individual with chronic pain.
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1-month after the intervention
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Perceived Partner Validation (Questionnaire)
Periodo de tiempo: During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
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Both partners' reports of partner's validation behavior, i.e., self-report for the partner, and other-report for the individual with chronic pain.
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During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
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Perceived Partner Invalidation (Questionnaire)
Periodo de tiempo: During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
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Both partners report on partner's invalidation behavior, i.e., self-report for the partner, and other-report for the individual with chronic pain.
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During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
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Ambivalence about emotional expression measured by Holding Back Scale (Questionnaire)
Periodo de tiempo: 1-month after the intervention
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1-month after the intervention
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Self- and Other-Oriented Distress (Questionnaire)
Periodo de tiempo: During lab visit, during discussion task (approx. 5 mins. after intervention) and during household tasks (approx. 15 - 35 mins. after intervention)
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Batson, Fultz, & Schoendrade, 1987.
Both partners' self-report of self- and other-oriented distress.
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During lab visit, during discussion task (approx. 5 mins. after intervention) and during household tasks (approx. 15 - 35 mins. after intervention)
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Individual with Chronic Pain's Emotional Expression (Questionnaire)
Periodo de tiempo: During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
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Both partners' report on individual with chronic pain's emotional expression.
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During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
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Individual with Chronic Pain's Pain Expression (Questionnaire)
Periodo de tiempo: During lab visit, during discussion task (approx. 5 mins. after intervention)and during household tasks (approx. 15 - 35 mins. after intervention)
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Both partners' report on individual with chronic pain's pain expression.
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During lab visit, during discussion task (approx. 5 mins. after intervention)and during household tasks (approx. 15 - 35 mins. after intervention)
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Perceived Division of Workload and Collaboration (Questionnaire)
Periodo de tiempo: After household tasks (approx. 35 - 45 mins. after intervention)
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Both partners' report on their perceptions of division of workload and collaboration during household tasks.
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After household tasks (approx. 35 - 45 mins. after intervention)
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Satisfaction with the discussion (Questionnaire)
Periodo de tiempo: After discussion (approx. 15 mins. after intervention)
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Both partners' report on their satisfaction with the discussion.
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After discussion (approx. 15 mins. after intervention)
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Satisfaction with household tasks
Periodo de tiempo: After household tasks (approx. 35 - 45 mins. after intervention)
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Both partners' report
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After household tasks (approx. 35 - 45 mins. after intervention)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Angelia M Corley, M.A., Wayne State University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
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)
1 de julio de 2016
Finalización primaria (Actual)
1 de diciembre de 2017
Finalización del estudio (Actual)
1 de junio de 2018
Fechas de registro del estudio
Enviado por primera vez
1 de agosto de 2016
Primero enviado que cumplió con los criterios de control de calidad
3 de agosto de 2016
Publicado por primera vez (Estimar)
9 de agosto de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de abril de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
21 de abril de 2019
Última verificación
1 de abril de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ACorley
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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