Study to Understand Pain Experiences in Relationships (SUPER)
21 april 2019 bijgewerkt door: Angelia Corley, Wayne State University
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Ingrijpend
Inschrijving (Werkelijk)
80
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Michigan
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Detroit, Michigan, Verenigde Staten, 48202
- Wayne State University's Relationships and Health Lab
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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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.
Andere namen:
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Placebo-vergelijker: 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.
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Pain Behavior (Behavioral coding)
Tijdsspanne: During lab visit, during household tasks conducted in the laboratory, approx. 15 - 35 mins. after partner training (intervention)
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Pain behaviors (e.g., grimacing, guarding) measured with behavioral coding conducted by research assistants.
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During lab visit, during household tasks conducted in the laboratory, approx. 15 - 35 mins. after partner training (intervention)
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Pain Intensity (0 - 10 self-report rating scale)
Tijdsspanne: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
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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.
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During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
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Pain Intensity (0 - 10 self-report rating scale)
Tijdsspanne: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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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.
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During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Number of Partner Validating Responses (Behavioral coding)
Tijdsspanne: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
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Validating responses will be coded by research assistants.
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During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
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Number of Partner Invalidating Responses (Behavioral coding)
Tijdsspanne: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
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Invalidating responses will be coded by research assistants.
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During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
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Pain-Related Emotional Disclosures (Behavioral coding)
Tijdsspanne: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Behavioral coding by research assistants, accounting for activity level during household tasks.
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During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Number of Partner Validating Responses (Behavioral coding)
Tijdsspanne: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Validating responses will be coded by research assistants
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During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Number of Partner Invalidating Responses (Behavioral coding)
Tijdsspanne: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Invalidating responses will be coded by research assistants
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During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Partner Instrumental support (Behavioral coding)
Tijdsspanne: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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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
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During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Individual with Chronic Pain Assistance Behavior (Behavioral coding)
Tijdsspanne: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Includes requests for assistance and accepting assistance, as measured by behavioral coding conducted by a research assistant
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During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Relationship Satisfaction (Questionnaire)
Tijdsspanne: 1-month after the intervention
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Couples Satisfaction Index, Funk & Rogge, 2007.
Both partners' self-reports of relationship satisfaction.
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1-month after the intervention
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Interpersonal Closeness (Questionnaire)
Tijdsspanne: 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
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Inclusion of Other in Self Scale, Aron, Aron, & Smollan, 1992.
Both partners' self-reports of interpersonal closeness.
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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
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Perceived Partner Responsiveness (Questionnaire)
Tijdsspanne: 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
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Reis et al., 2003.Both partners' self-reports on Perceived Partner Responsiveness.
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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
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Pain Intensity (Questionnaire)
Tijdsspanne: 1-month after the intervention
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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.
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1-month after the intervention
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Accuracy of Estimate of Individual with Chronic Pain's Pain Intensity
Tijdsspanne: 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
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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.
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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
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Close other responses to pain and partner support (Questionnaire)
Tijdsspanne: 1-month after the intervention
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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.
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1-month after the intervention
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Perceived Partner Validation (Questionnaire)
Tijdsspanne: 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
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Both partners' reports of partner's validation behavior, i.e., self-report for the partner, and other-report for the individual with chronic pain.
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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
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Perceived Partner Invalidation (Questionnaire)
Tijdsspanne: 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
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Both partners report on partner's invalidation behavior, i.e., self-report for the partner, and other-report for the individual with chronic pain.
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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
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Ambivalence about emotional expression measured by Holding Back Scale (Questionnaire)
Tijdsspanne: 1-month after the intervention
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1-month after the intervention
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Self- and Other-Oriented Distress (Questionnaire)
Tijdsspanne: During lab visit, during discussion task (approx. 5 mins. after intervention) and during household tasks (approx. 15 - 35 mins. after intervention)
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Batson, Fultz, & Schoendrade, 1987.
Both partners' self-report of self- and other-oriented distress.
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During lab visit, during discussion task (approx. 5 mins. after intervention) and during household tasks (approx. 15 - 35 mins. after intervention)
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Individual with Chronic Pain's Emotional Expression (Questionnaire)
Tijdsspanne: 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
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Both partners' report on individual with chronic pain's emotional expression.
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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
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Individual with Chronic Pain's Pain Expression (Questionnaire)
Tijdsspanne: During lab visit, during discussion task (approx. 5 mins. after intervention)and during household tasks (approx. 15 - 35 mins. after intervention)
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Both partners' report on individual with chronic pain's pain expression.
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During lab visit, during discussion task (approx. 5 mins. after intervention)and during household tasks (approx. 15 - 35 mins. after intervention)
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Perceived Division of Workload and Collaboration (Questionnaire)
Tijdsspanne: After household tasks (approx. 35 - 45 mins. after intervention)
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Both partners' report on their perceptions of division of workload and collaboration during household tasks.
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After household tasks (approx. 35 - 45 mins. after intervention)
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Satisfaction with the discussion (Questionnaire)
Tijdsspanne: After discussion (approx. 15 mins. after intervention)
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Both partners' report on their satisfaction with the discussion.
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After discussion (approx. 15 mins. after intervention)
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Satisfaction with household tasks
Tijdsspanne: After household tasks (approx. 35 - 45 mins. after intervention)
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Both partners' report
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After household tasks (approx. 35 - 45 mins. after intervention)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Angelia M Corley, M.A., Wayne State University
Publicaties en nuttige links
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Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juli 2016
Primaire voltooiing (Werkelijk)
1 december 2017
Studie voltooiing (Werkelijk)
1 juni 2018
Studieregistratiedata
Eerst ingediend
1 augustus 2016
Eerst ingediend dat voldeed aan de QC-criteria
3 augustus 2016
Eerst geplaatst (Schatting)
9 augustus 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
23 april 2019
Laatste update ingediend die voldeed aan QC-criteria
21 april 2019
Laatst geverifieerd
1 april 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ACorley
Plan Individuele Deelnemersgegevens (IPD)
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