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Study to Understand Pain Experiences in Relationships (SUPER)

21. dubna 2019 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

80

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Michigan
      • Detroit, Michigan, Spojené státy, 48202
        • Wayne State University's Relationships and Health Lab

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: 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.
Ostatní jména:
  • Ověření
Komparátor placeba: 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.
Behaviorální: 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.
Ostatní jména:
  • Vzdělání

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Pain Behavior (Behavioral coding)
Časové okno: During lab visit, during household tasks conducted in the laboratory, approx. 15 - 35 mins. after partner training (intervention)
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)
Časové okno: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
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)
Časové okno: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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)
Časové okno: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
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)
Časové okno: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
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)
Časové okno: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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)
Časové okno: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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)
Časové okno: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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)
Časové okno: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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)
Časové okno: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Relationship Satisfaction (Questionnaire)
Časové okno: 1-month after the intervention
Couples Satisfaction Index, Funk & Rogge, 2007. Both partners' self-reports of relationship satisfaction.
1-month after the intervention
Interpersonal Closeness (Questionnaire)
Časové okno: 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
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
Perceived Partner Responsiveness (Questionnaire)
Časové okno: 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
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
Pain Intensity (Questionnaire)
Časové okno: 1-month after the intervention
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
Accuracy of Estimate of Individual with Chronic Pain's Pain Intensity
Časové okno: 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
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
Close other responses to pain and partner support (Questionnaire)
Časové okno: 1-month after the intervention
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
Perceived Partner Validation (Questionnaire)
Časové okno: 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
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
Perceived Partner Invalidation (Questionnaire)
Časové okno: 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
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
Ambivalence about emotional expression measured by Holding Back Scale (Questionnaire)
Časové okno: 1-month after the intervention
  • (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
Self- and Other-Oriented Distress (Questionnaire)
Časové okno: During lab visit, during discussion task (approx. 5 mins. after intervention) and during household tasks (approx. 15 - 35 mins. after intervention)
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)
Individual with Chronic Pain's Emotional Expression (Questionnaire)
Časové okno: 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
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
Individual with Chronic Pain's Pain Expression (Questionnaire)
Časové okno: During lab visit, during discussion task (approx. 5 mins. after intervention)and during household tasks (approx. 15 - 35 mins. after intervention)
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)
Perceived Division of Workload and Collaboration (Questionnaire)
Časové okno: After household tasks (approx. 35 - 45 mins. after intervention)
Both partners' report on their perceptions of division of workload and collaboration during household tasks.
After household tasks (approx. 35 - 45 mins. after intervention)
Satisfaction with the discussion (Questionnaire)
Časové okno: After discussion (approx. 15 mins. after intervention)
Both partners' report on their satisfaction with the discussion.
After discussion (approx. 15 mins. after intervention)
Satisfaction with household tasks
Časové okno: After household tasks (approx. 35 - 45 mins. after intervention)
Both partners' report
After household tasks (approx. 35 - 45 mins. after intervention)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Wayne State University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Angelia M Corley, M.A., Wayne State University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. července 2016

Primární dokončení (Aktuální)

1. prosince 2017

Dokončení studie (Aktuální)

1. června 2018

Termíny zápisu do studia

První předloženo

1. srpna 2016

První předloženo, které splnilo kritéria kontroly kvality

3. srpna 2016

První zveřejněno (Odhad)

9. srpna 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

23. dubna 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

21. dubna 2019

Naposledy ověřeno

1. dubna 2019

Více informací

Termíny související s touto studií

Klíčová slova

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Další identifikační čísla studie

  • ACorley

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