- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01776645
Compassion Training and Pain
24. oktober 2013 opdateret af: Stanford University
The purpose of this study is to determine whether compassion training will improve the physical and psychological well-being of patients with chronic pain.
The investigators also want to determine whether any benefit of compassion training in the patients "spreads" to significant others with whom the patient has a close relationship.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
56
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Palo Alto, California, Forenede Stater, 94304
- Stanford University School of Medicine
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age 18+ and chronic pain for >6months
- Pain over the last month
- Ability to read, write, and converse in English
- If being treated for pain condition, then stable treatment regimen.
For significant others:
1)18 years of age or older 2)Ability to read, write, and converse in English
Exclusion Criteria:
For patients and significant others:
1)Current or history of a psychological disorder that would interfere with study procedures, at the discretion of the researcher.
For patients only:
- prior compassion meditation experience
- on going legal action or disability claim
- currently pregnant or planning to become pregnant
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Compassion cultivation training
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Brief Pain Inventory
Tidsramme: Baseline and end of 9-week treatment protocol
|
Intensity - pain severity as measured by a 0 to 10 visual analogue scale.
0 = no pain, 10 = worst pain imaginable
|
Baseline and end of 9-week treatment protocol
|
|
Change in Chronic Pain Acceptance Questionnaire
Tidsramme: Baseline and end of 9-week treatment protocol
|
Baseline and end of 9-week treatment protocol
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Brief Pain Inventory
Tidsramme: Baseline to end of 9-week treatment protocol
|
Interference score - Interference as measured by a 0 to 10 numerical rating scale.
0 = does not interfere, 10 = completely interferes
|
Baseline to end of 9-week treatment protocol
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Emotional Distress
Tidsramme: Baseline and end of 9-week treatment protocol
|
As assessed by the Hospital Anxiety and Depression Scale
|
Baseline and end of 9-week treatment protocol
|
|
Change in Overall Health and Well-being
Tidsramme: Baseline and end of 9-week treatment protocol
|
As assessed by Ryff's psychological well-being scales
|
Baseline and end of 9-week treatment protocol
|
|
Change in Compassion
Tidsramme: Baseline and end of 9-week treatment protocol
|
As assessed by Neff's Self-Compassion Scale
|
Baseline and end of 9-week treatment protocol
|
|
Qualitative Measures
Tidsramme: Baseline and end of 9-week treatment protocol
|
Qualitative analysis of interviews
|
Baseline and end of 9-week treatment protocol
|
|
Change in Emotional Distress
Tidsramme: Baseline and end of 9-week treatment protocol
|
As Assessed by the PROMIS Anger Scale
|
Baseline and end of 9-week treatment protocol
|
|
Change in Emotional Distress
Tidsramme: Baseline and end of 9-week treatment protocol
|
As assessed by the PROMIS Social Isolation Scale
|
Baseline and end of 9-week treatment protocol
|
|
Change in Overall Health and Well-being
Tidsramme: Baseline and end of 9-week treatment protocol
|
As assessed by PROMIS Global Health Scale
|
Baseline and end of 9-week treatment protocol
|
|
Change in Compassion
Tidsramme: Baseline and end of 9-week treatment protocol
|
As assessed by Compassionate Love Scale adapted for close other
|
Baseline and end of 9-week treatment protocol
|
|
Change in Compassion
Tidsramme: Baseline and end of 9-week treatment protocol
|
As assessed by Pommier's Compassion for Other's Scale
|
Baseline and end of 9-week treatment protocol
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2013
Primær færdiggørelse (Faktiske)
1. maj 2013
Studieafslutning (Faktiske)
1. maj 2013
Datoer for studieregistrering
Først indsendt
15. januar 2013
Først indsendt, der opfyldte QC-kriterier
23. januar 2013
Først opslået (Skøn)
28. januar 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. december 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. oktober 2013
Sidst verificeret
1. oktober 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 25883
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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-
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