Study to Understand Pain Experiences in Relationships

NCT02859545 | Completed

• 1 other identifier: ACorley
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

chronic pain; pain; validation; couples; romantic relationships; emotional validation

Outcome Measures

Primary Outcomes (10)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (15)

• 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

• 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

Study Arms (2)

Validation Training

EXPERIMENTAL

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.

Behavioral: Emotional Validation Training for Romantic Partners

Education Training

PLACEBO COMPARATOR

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.

Behavioral: Chronic Pain Education Training for Romantic Partners

Interventions

Emotional Validation Training for Romantic Partners BEHAVIORAL

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.

Also known as: Validation

Validation Training

Chronic Pain Education Training for Romantic Partners BEHAVIORAL

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.

Also known as: Education

Education Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University's Relationships and Health Lab

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Chronic Pain; Pain

Interventions

Validation Studies as Topic; Educational Status

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Evaluation Studies as Topic; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Socioeconomic Factors; Population Characteristics

Study Officials

• Angelia M Corley, M.A.

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Research Assistant

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 9, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)