Study to Understand Pain Experiences in Relationships (SUPER)
21 апреля 2019 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Тип исследования
Интервенционный
Регистрация (Действительный)
80
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Michigan
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Detroit, Michigan, Соединенные Штаты, 48202
- Wayne State University's Relationships and Health Lab
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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)
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
Другие имена:
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Плацебо Компаратор: 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.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Pain Behavior (Behavioral coding)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
|
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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Relationship Satisfaction (Questionnaire)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 1-month after the intervention
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1-month after the intervention
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Self- and Other-Oriented Distress (Questionnaire)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Angelia M Corley, M.A., Wayne State University
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Полезные ссылки
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 июля 2016 г.
Первичное завершение (Действительный)
1 декабря 2017 г.
Завершение исследования (Действительный)
1 июня 2018 г.
Даты регистрации исследования
Первый отправленный
1 августа 2016 г.
Впервые представлено, что соответствует критериям контроля качества
3 августа 2016 г.
Первый опубликованный (Оценивать)
9 августа 2016 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
23 апреля 2019 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
21 апреля 2019 г.
Последняя проверка
1 апреля 2019 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- ACorley
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .