Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Study to Understand Pain Experiences in Relationships (SUPER)

21. april 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Michigan
      • Detroit, Michigan, Forente stater, 48202
        • Wayne State University's Relationships and Health Lab

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Andre navn:
  • Validation
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.
Atferdsmessig: 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.
Andre navn:
  • Utdanning

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain Behavior (Behavioral coding)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Relationship Satisfaction (Questionnaire)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: After household tasks (approx. 35 - 45 mins. after intervention)
Both partners' report
After household tasks (approx. 35 - 45 mins. after intervention)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Wayne State University

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juli 2016

Primær fullføring (Faktiske)

1. desember 2017

Studiet fullført (Faktiske)

1. juni 2018

Datoer for studieregistrering

Først innsendt

1. august 2016

Først innsendt som oppfylte QC-kriteriene

3. august 2016

Først lagt ut (Anslag)

9. august 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. april 2019

Sist bekreftet

1. april 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ACorley

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Kronisk smerte

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Cote d'Ivoire

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere