- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02038244
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Essen, Tyskland
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Integrative Medicine
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain Intensity
Tidsram: 14 days
|
VAS
|
14 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain Intensity
Tidsram: 6 months
|
VAS
|
6 months
|
|
Pain Disability
Tidsram: 14 days, 6 months
|
- German Pain Questionnaire
|
14 days, 6 months
|
|
Health-related quality of life
Tidsram: 14 days, 6 months
|
Short Form (36) Health Survey
|
14 days, 6 months
|
|
Life satisfaction
Tidsram: 14 days, 6 months
|
Brief Multidimensional Life Satisfaction Scale
|
14 days, 6 months
|
|
Depression
Tidsram: 14 days, 6 months
|
Beck Depression Inventory
|
14 days, 6 months
|
|
Acceptance
Tidsram: 14 days, 6 months
|
Emotional/Rational Disease Acceptance Questionnaire
|
14 days, 6 months
|
|
Mindfulness
Tidsram: 14 days, 6 months
|
Conscious Presence and Self Control (CPSC) Scale
|
14 days, 6 months
|
|
Subjective stress
Tidsram: 14 days, 6 months
|
Perceived Stress Scale
|
14 days, 6 months
|
|
Easiness of life
Tidsram: 14 days, 6 months
|
Questionnaire on emotional and physical reactions
|
14 days, 6 months
|
|
Ability and will to change
Tidsram: 14 days, 6 months
|
Ability and will to change Questionnaire
|
14 days, 6 months
|
|
Safety
Tidsram: 14 days, 6 months
|
Adverse events
|
14 days, 6 months
|
|
Pain Disability
Tidsram: 14 days, 6 months
|
- Pain Disability Index
|
14 days, 6 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Body awareness
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
|
Daily log
Tidsram: 2 weeks
|
Daily rating of pain and well-being on a 100mm visual analog scale.
|
2 weeks
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 135393-BO
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