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CompletedNCT02859545SUPERUpdated Apr 23, 2019

Study to Understand Pain Experiences in Relationships

An interventional study of Emotional Validation Training for Romantic Partners and Chronic Pain Education Training for Romantic Partners in Chronic Pain, sponsored by Wayne State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-23.

Sponsored by Wayne State University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Pain

Keywords

  • chronic pain
  • pain
  • validation
  • couples
  • romantic relationships
  • emotional validation
03

In context

Chronic Pain

2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.

This study's enrollment of 80 is above the median of 60 across 2,209 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Wayne State University is the lead sponsor of 229 studies on the registry; 34 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Browse Wayne State University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Emotional Validation Training for Romantic Partners

  • Placebo comparator
    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.

    Behavioral: Chronic Pain Education Training for Romantic Partners

Interventions

  • BehavioralEmotional 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.

    Also known as: Validation

  • BehavioralChronic 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.

    Also known as: Education

06

What researchers measure

Primary outcomes

  1. Pain Behavior (Behavioral coding)

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

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

  2. 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.

    Time frame: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)

  3. 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.

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

  4. Number of Partner Validating Responses (Behavioral coding)

    Validating responses will be coded by research assistants.

    Time frame: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)

  5. Number of Partner Invalidating Responses (Behavioral coding)

    Invalidating responses will be coded by research assistants.

    Time frame: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)

  6. Pain-Related Emotional Disclosures (Behavioral coding)

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

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

  7. Number of Partner Validating Responses (Behavioral coding)

    Validating responses will be coded by research assistants

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

  8. Number of Partner Invalidating Responses (Behavioral coding)

    Invalidating responses will be coded by research assistants

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

  9. 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

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

  10. 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

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

Secondary outcomes

  1. Relationship Satisfaction (Questionnaire)

    Couples Satisfaction Index, Funk \& Rogge, 2007. Both partners' self-reports of relationship satisfaction.

    Time frame: 1-month after the intervention

  2. Interpersonal Closeness (Questionnaire)

    Inclusion of Other in Self Scale, Aron, Aron, \& Smollan, 1992. Both partners' self-reports of interpersonal closeness.

    Time frame: 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

  3. Perceived Partner Responsiveness (Questionnaire)

    Reis et al., 2003.Both partners' self-reports on Perceived Partner Responsiveness.

    Time frame: 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

  4. 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.

    Time frame: 1-month after the intervention

  5. 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.

    Time frame: 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

  6. 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.

    Time frame: 1-month after the intervention

  7. 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.

    Time frame: 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

  8. 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.

    Time frame: 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

  9. 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.

    Time frame: 1-month after the intervention

  10. Self- and Other-Oriented Distress (Questionnaire)

    Batson, Fultz, \& Schoendrade, 1987. Both partners' self-report of self- and other-oriented distress.

    Time frame: During lab visit, during discussion task (approx. 5 mins. after intervention) and during household tasks (approx. 15 - 35 mins. after intervention)

  11. Individual with Chronic Pain's Emotional Expression (Questionnaire)

    Both partners' report on individual with chronic pain's emotional expression.

    Time frame: 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

  12. Individual with Chronic Pain's Pain Expression (Questionnaire)

    Both partners' report on individual with chronic pain's pain expression.

    Time frame: During lab visit, during discussion task (approx. 5 mins. after intervention)and during household tasks (approx. 15 - 35 mins. after intervention)

  13. Perceived Division of Workload and Collaboration (Questionnaire)

    Both partners' report on their perceptions of division of workload and collaboration during household tasks.

    Time frame: After household tasks (approx. 35 - 45 mins. after intervention)

  14. Satisfaction with the discussion (Questionnaire)

    Both partners' report on their satisfaction with the discussion.

    Time frame: After discussion (approx. 15 mins. after intervention)

  15. Satisfaction with household tasks

    Both partners' report

    Time frame: After household tasks (approx. 35 - 45 mins. after intervention)

07

Study locations

1 site
  • Wayne State University's Relationships and Health Lab
    Detroit, Michigan 48202, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2016 to primary completion in Dec 2017, 17 months.

Of 1,209 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 17 months is below that.

Counting every sponsor, half of 1,296 studies reached it within 21 months; a quarter within 9 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2016
First posted
Aug 9, 2016
StartActual
Jul 2016
Primary completionActual
Dec 2017
CompletionActual
Jun 2018
Last update
Apr 23, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02859545
Lead sponsor
Wayne State University
Responsible party
Angelia Corley (Graduate Research Assistant, Wayne State University) — Principal investigator
First posted
Aug 9, 2016
Start date
Jul 2016
Primary completion
Dec 2017
Completion
Jun 2018
Last update
Apr 23, 2019

Study contacts

Angelia M Corley, M.A.
principal investigator · Wayne State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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