Integrative Medicine for Chronic Pain (POSITIVE)
Integrative Medicine for Chronic Pain - Process-Outcome-Study in the Context of an Internal Medicine Ward for Integrative Medicine
In this study, the effects of a 14-day inpatient treatment in an internal medicine ward for integrative medicine on pain, disability, quality of life, satisfaction with life, depression, and anxiety will be investigated. Furthermore the influence of potential process variables will be evaluated.
Effects will be measured after completion of the program (2 weeks), and at 6 months follow up after start of the program.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Essen, Tyskland
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- diagnosed with any chronic pain condition
- at least 6 months pain duration
- written informed consent
Exclusion Criteria:
- participation in any other clinical study
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Integrative Medicine
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Intensity
Tidsramme: 14 days
|
VAS
|
14 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Intensity
Tidsramme: 6 months
|
VAS
|
6 months
|
|
Pain Disability
Tidsramme: 14 days, 6 months
|
- German Pain Questionnaire
|
14 days, 6 months
|
|
Health-related quality of life
Tidsramme: 14 days, 6 months
|
Short Form (36) Health Survey
|
14 days, 6 months
|
|
Life satisfaction
Tidsramme: 14 days, 6 months
|
Brief Multidimensional Life Satisfaction Scale
|
14 days, 6 months
|
|
Depression
Tidsramme: 14 days, 6 months
|
Beck Depression Inventory
|
14 days, 6 months
|
|
Acceptance
Tidsramme: 14 days, 6 months
|
Emotional/Rational Disease Acceptance Questionnaire
|
14 days, 6 months
|
|
Mindfulness
Tidsramme: 14 days, 6 months
|
Conscious Presence and Self Control (CPSC) Scale
|
14 days, 6 months
|
|
Subjective stress
Tidsramme: 14 days, 6 months
|
Perceived Stress Scale
|
14 days, 6 months
|
|
Easiness of life
Tidsramme: 14 days, 6 months
|
Questionnaire on emotional and physical reactions
|
14 days, 6 months
|
|
Ability and will to change
Tidsramme: 14 days, 6 months
|
Ability and will to change Questionnaire
|
14 days, 6 months
|
|
Safety
Tidsramme: 14 days, 6 months
|
Adverse events
|
14 days, 6 months
|
|
Pain Disability
Tidsramme: 14 days, 6 months
|
- Pain Disability Index
|
14 days, 6 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Body awareness
Tidsramme: 14 days, 6 months
|
Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes. - Body Awareness Questionnaire (BAQ) (Shields 1989) |
14 days, 6 months
|
|
Body responsiveness
Tidsramme: 14 days, 6 months
|
Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes.
|
14 days, 6 months
|
|
Body awareness and dissociation
Tidsramme: 14 days, 6 months
|
Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes. - Scale of Body Connection (SBC) (Price and Thompson 2007) |
14 days, 6 months
|
|
Postural awareness
Tidsramme: 14 days, 6 months
|
Newly developed body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes. - Postural Awareness Scale (PAS) (Cramer et al.) |
14 days, 6 months
|
|
Body awareness
Tidsramme: 14 days, 6 months
|
The DKB will be used for mediation and moderator analysis with the outcomes and for validation purposes. - Dresden Body Image Questionnaire (DKB) (Pöhlmann et al., 2007) |
14 days, 6 months
|
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Daily log
Tidsramme: 2 weeks
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Daily rating of pain and well-being on a 100mm visual analog scale.
|
2 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 135393-BO
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