Clinical trial NCT02859545: Study to Understand Pain Experiences in Relationships
Official title: Study to Understand Pain Experiences in Relationships
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
pain
validation
couples
romantic relationships
emotional validation
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Pain Behavior (Behavioral coding)
timeFrame: During lab visit, during household tasks conducted in the laboratory, approx. 15 - 35 mins. after partner training (intervention)
measure: Pain Intensity (0 - 10 self-report rating scale)
timeFrame: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
measure: Pain Intensity (0 - 10 self-report rating scale)
timeFrame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
measure: Number of Partner Validating Responses (Behavioral coding)
timeFrame: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
measure: Number of Partner Invalidating Responses (Behavioral coding)
timeFrame: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
measure: Pain-Related Emotional Disclosures (Behavioral coding)
timeFrame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
measure: Number of Partner Validating Responses (Behavioral coding)
timeFrame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
measure: Number of Partner Invalidating Responses (Behavioral coding)
timeFrame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
measure: Partner Instrumental support (Behavioral coding)
timeFrame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
measure: Individual with Chronic Pain Assistance Behavior (Behavioral coding)
timeFrame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Secondary outcomes:
measure: Relationship Satisfaction (Questionnaire)
timeFrame: 1-month after the intervention
measure: Interpersonal Closeness (Questionnaire)
timeFrame: 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
measure: Perceived Partner Responsiveness (Questionnaire)
timeFrame: 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
measure: Pain Intensity (Questionnaire)
timeFrame: 1-month after the intervention
measure: Accuracy of Estimate of Individual with Chronic Pain's Pain Intensity
timeFrame: 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
measure: Close other responses to pain and partner support (Questionnaire)
timeFrame: 1-month after the intervention
measure: Perceived Partner Validation (Questionnaire)
timeFrame: 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
measure: Perceived Partner Invalidation (Questionnaire)
timeFrame: 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
measure: Ambivalence about emotional expression measured by Holding Back Scale (Questionnaire)
timeFrame: 1-month after the intervention
measure: Self- and Other-Oriented Distress (Questionnaire)
timeFrame: During lab visit, during discussion task (approx. 5 mins. after intervention) and during household tasks (approx. 15 - 35 mins. after intervention)
measure: Individual with Chronic Pain's Emotional Expression (Questionnaire)
timeFrame: 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
measure: Individual with Chronic Pain's Pain Expression (Questionnaire)
timeFrame: During lab visit, during discussion task (approx. 5 mins. after intervention)and during household tasks (approx. 15 - 35 mins. after intervention)
measure: Perceived Division of Workload and Collaboration (Questionnaire)
timeFrame: After household tasks (approx. 35 - 45 mins. after intervention)
measure: Satisfaction with the discussion (Questionnaire)
timeFrame: After discussion (approx. 15 mins. after intervention)
measure: Satisfaction with household tasks
timeFrame: After household tasks (approx. 35 - 45 mins. after intervention)
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University's Relationships and Health Lab
state: Michigan
Study officials:
affiliation: Wayne State University
name: Angelia M Corley, M.A.
role: PRINCIPAL_INVESTIGATOR
References: