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Study to Understand Pain Experiences in Relationships (SUPER)

21. April 2019 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Michigan
      • Detroit, Michigan, Vereinigte Staaten, 48202
        • Wayne State University's Relationships and Health Lab

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: 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.
Andere Namen:
  • Validierung
Placebo-Komparator: 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.
Verhalten: 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.
Andere Namen:
  • Ausbildung

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain Behavior (Behavioral coding)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Relationship Satisfaction (Questionnaire)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: After household tasks (approx. 35 - 45 mins. after intervention)
Both partners' report
After household tasks (approx. 35 - 45 mins. after intervention)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Wayne State University

Ermittler

  • Hauptermittler: Angelia M Corley, M.A., Wayne State University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juli 2016

Primärer Abschluss (Tatsächlich)

1. Dezember 2017

Studienabschluss (Tatsächlich)

1. Juni 2018

Studienanmeldedaten

Zuerst eingereicht

1. August 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. August 2016

Zuerst gepostet (Schätzen)

9. August 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. April 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. April 2019

Zuletzt verifiziert

1. April 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ACorley

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