Study to Understand Pain Experiences in Relationships

Chronic Pain Clinical Trial

— SUPER  

Official title:

Study to Understand Pain Experiences in Relationships

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02859545
• Other study ID #: ACorley
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 2018

Study information

• Verified date: April 2019
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Emotional Validation Training for Romantic Partners
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.
• Chronic Pain Education Training for Romantic Partners
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.

Locations

Country	Name	City	State
United States	Wayne State University's Relationships and Health Lab	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Behavior (Behavioral coding)	Pain behaviors (e.g., grimacing, guarding) measured with behavioral coding conducted by research assistants.	During lab visit, during household tasks conducted in the laboratory, approx. 15 - 35 mins. after partner training (intervention)
Primary	Pain Intensity (0 - 10 self-report rating scale)	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.	During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
Primary	Pain Intensity (0 - 10 self-report rating scale)	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.	During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Primary	Number of Partner Validating Responses (Behavioral coding)	Validating responses will be coded by research assistants.	During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
Primary	Number of Partner Invalidating Responses (Behavioral coding)	Invalidating responses will be coded by research assistants.	During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
Primary	Pain-Related Emotional Disclosures (Behavioral coding)	Behavioral coding by research assistants, accounting for activity level during household tasks.	During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Primary	Number of Partner Validating Responses (Behavioral coding)	Validating responses will be coded by research assistants	During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Primary	Number of Partner Invalidating Responses (Behavioral coding)	Invalidating responses will be coded by research assistants	During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Primary	Partner Instrumental support (Behavioral coding)	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	During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Primary	Individual with Chronic Pain Assistance Behavior (Behavioral coding)	Includes requests for assistance and accepting assistance, as measured by behavioral coding conducted by a research assistant	During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Secondary	Relationship Satisfaction (Questionnaire)	Couples Satisfaction Index, Funk & Rogge, 2007. Both partners' self-reports of relationship satisfaction.	1-month after the intervention
Secondary	Interpersonal Closeness (Questionnaire)	Inclusion of Other in Self Scale, Aron, Aron, & Smollan, 1992. Both partners' self-reports of interpersonal closeness.	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
Secondary	Perceived Partner Responsiveness (Questionnaire)	Reis et al., 2003.Both partners' self-reports on Perceived Partner Responsiveness.	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
Secondary	Pain Intensity (Questionnaire)	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.	1-month after the intervention
Secondary	Accuracy of Estimate of Individual with Chronic Pain's Pain Intensity	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.	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
Secondary	Close other responses to pain and partner support (Questionnaire)	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.	1-month after the intervention
Secondary	Perceived Partner Validation (Questionnaire)	Both partners' reports of partner's validation behavior, i.e., self-report for the partner, and other-report for the individual with chronic pain.	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
Secondary	Perceived Partner Invalidation (Questionnaire)	Both partners report on partner's invalidation behavior, i.e., self-report for the partner, and other-report for the individual with chronic pain.	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
Secondary	Ambivalence about emotional expression measured by Holding Back Scale (Questionnaire)	(Holding Back Scale; Pistrang & Barker, 1995); (Holding Back Scale; Pistrang & Barker, 1995); (Holding Back Scale; Pistrang & Barker, 1995); (Holding Back Scale; Pistrang & Barker, 1995); (Holding Back Scale; Pistrang & Barker, 1995) Holding Back Scale, Pistrang & Barker, 1995; Both partners report on individual with chronic pain's behavior.	1-month after the intervention
Secondary	Self- and Other-Oriented Distress (Questionnaire)	Batson, Fultz, & Schoendrade, 1987. Both partners' self-report of self- and other-oriented distress.	During lab visit, during discussion task (approx. 5 mins. after intervention) and during household tasks (approx. 15 - 35 mins. after intervention)
Secondary	Individual with Chronic Pain's Emotional Expression (Questionnaire)	Both partners' report on individual with chronic pain's emotional expression.	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
Secondary	Individual with Chronic Pain's Pain Expression (Questionnaire)	Both partners' report on individual with chronic pain's pain expression.	During lab visit, during discussion task (approx. 5 mins. after intervention)and during household tasks (approx. 15 - 35 mins. after intervention)
Secondary	Perceived Division of Workload and Collaboration (Questionnaire)	Both partners' report on their perceptions of division of workload and collaboration during household tasks.	After household tasks (approx. 35 - 45 mins. after intervention)
Secondary	Satisfaction with the discussion (Questionnaire)	Both partners' report on their satisfaction with the discussion.	After discussion (approx. 15 mins. after intervention)
Secondary	Satisfaction with household tasks	Both partners' report	After household tasks (approx. 35 - 45 mins. after intervention)

External Links

•   Relationships and Health Laboratory Website