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Clinical Trials/NCT02859545
NCT02859545
Completed
Not Applicable

Study to Understand Pain Experiences in Relationships

Wayne State University1 site in 1 country80 target enrollmentJuly 2016
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Wayne State University
Enrollment
80
Locations
1
Primary Endpoint
Number of Partner Validating Responses (Behavioral coding)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
June 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Angelia Corley

Graduate Research Assistant

Wayne State University

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Number of Partner Validating Responses (Behavioral coding)

Time Frame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)

Validating responses will be coded by research assistants

Number of Partner Invalidating Responses (Behavioral coding)

Time Frame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)

Invalidating responses will be coded by research assistants

Pain Behavior (Behavioral coding)

Time Frame: During lab visit, during household tasks conducted in the laboratory, approx. 15 - 35 mins. after partner training (intervention)

Pain behaviors (e.g., grimacing, guarding) measured with behavioral coding conducted by research assistants.

Pain Intensity (0 - 10 self-report rating scale)

Time Frame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)

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.

Individual with Chronic Pain Assistance Behavior (Behavioral coding)

Time Frame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)

Includes requests for assistance and accepting assistance, as measured by behavioral coding conducted by a research assistant

Pain-Related Emotional Disclosures (Behavioral coding)

Time Frame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)

Behavioral coding by research assistants, accounting for activity level during household tasks.

Partner Instrumental support (Behavioral coding)

Time Frame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)

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

Secondary Outcomes

  • Self- and Other-Oriented Distress (Questionnaire)(During lab visit, during discussion task (approx. 5 mins. after intervention) and during household tasks (approx. 15 - 35 mins. after intervention))
  • Relationship Satisfaction (Questionnaire)(1-month after the intervention)
  • Interpersonal Closeness (Questionnaire)(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)
  • Perceived Partner Responsiveness (Questionnaire)(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)
  • Individual with Chronic Pain's Emotional Expression (Questionnaire)(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)
  • Individual with Chronic Pain's Pain Expression (Questionnaire)(During lab visit, during discussion task (approx. 5 mins. after intervention)and during household tasks (approx. 15 - 35 mins. after intervention))
  • Satisfaction with household tasks(After household tasks (approx. 35 - 45 mins. after intervention))
  • Perceived Division of Workload and Collaboration (Questionnaire)(After household tasks (approx. 35 - 45 mins. after intervention))
  • Satisfaction with the discussion (Questionnaire)(After discussion (approx. 15 mins. after intervention))
  • Pain Intensity (Questionnaire)(1-month after the intervention)
  • Accuracy of Estimate of Individual with Chronic Pain's Pain Intensity(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)
  • Close other responses to pain and partner support (Questionnaire)(1-month after the intervention)
  • Perceived Partner Validation (Questionnaire)(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)
  • Perceived Partner Invalidation (Questionnaire)(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)
  • Ambivalence about emotional expression measured by Holding Back Scale (Questionnaire)(1-month after the intervention)

Study Sites (1)

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