Study to Understand Pain Experiences in Relationships (SUPER)
2019년 4월 21일 업데이트: 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.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
80
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Michigan
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Detroit, Michigan, 미국, 48202
- Wayne State University's Relationships and Health Lab
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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위약 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain Behavior (Behavioral coding)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Relationship Satisfaction (Questionnaire)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 1-month after the intervention
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1-month after the intervention
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Self- and Other-Oriented Distress (Questionnaire)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Angelia M Corley, M.A., Wayne State University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 7월 1일
기본 완료 (실제)
2017년 12월 1일
연구 완료 (실제)
2018년 6월 1일
연구 등록 날짜
최초 제출
2016년 8월 1일
QC 기준을 충족하는 최초 제출
2016년 8월 3일
처음 게시됨 (추정)
2016년 8월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 4월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 4월 21일
마지막으로 확인됨
2019년 4월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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