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This study aims to test, if a two-week integrative therapy in an internal medicine ward will improve symptoms, disability and quality of life in patients with inflammatory bowel disease or irritable bowel syndrome.a It shall further be tested, if those changes are associated with attitudes and experiences towards complementary and alternative medicine, anxiety, depression and stress perception as well as body awareness and responsiveness.
see above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrative Therapy | This group receives and integrative therapy at the Department of Internal and Integrative Medicine, i.e. a combination of conventional diagnostic and therapeutic interventions with specific naturopathic, and complementary medicine approaches, and physical therapy. Patients are admitted to the hospital ward for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrative Therapy | Other | This group receives an integrative therapy at the Department of Internal and Integrative Medicine, i.e. a combination of conventional diagnostic and therapeutic interventions with specific naturopathic, and complementary medicine approaches, and physical therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms Severity IBS-SSS | Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997) | 2 weeks |
| Symptoms Severity CAI | Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989) | 2 weeks |
| Symptoms Severity CDAI | Symptoms Severity assessed by Crohn Disease Activity Index (CDAI) | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms Severity IBS-SSS | Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997) | 24 weeks |
| Symptoms Severity CAI | Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989) |
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Inclusion Criteria:
Exclusion Criteria:
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100 patients with Inflammentory Bowel Disease admitted to the Department of Internal and Integrative Medicine.
100 patients with Irritable Bowel Syndrome admitted to the Department of Internal and Integrative Medicine.
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| Name | Affiliation | Role |
|---|---|---|
| Gustav Dobos, Prof, MD | Department of Internal and Integrative Medicine, Kliniken Essen-Mitte | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal and Integrative Medicine, Kliniken Essen-Mitte | Essen | 45276 | Germany |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
| 24 weeks |
| Symptoms Severity CDAI | Symptoms Severity assessed by Crohn Disease Activity Index (CDAI) | 24 weeks |
| Disability MYMOP | Disability assessed by Measure Yourself Medical Outcome Profile (MYMOP) (Paterson 1996) | 2 weeks |
| Disability MYMOP | Disability assessed by Measure Yourself Medical Outcome Profile (MYMOP) (Paterson 1996) | 24 weeks |
| Quality of Life IBS-QOL | Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL) (Patrick, 1998) | 2 weeks |
| Quality of Life IBS-QOL | Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL) (Patrick, 1998) | 24 weeks |
| Quality of Life IBDQ | Inflammatory Bowel Disease Questionnaire (IBDQ) (Cooney et al., 2007) | 2 weeks |
| Quality of Life IBDQ | Inflammatory Bowel Disease Questionnaire (IBDQ) (Cooney et al., 2007) | 24 weeks |
| Self efficacy questionnaire SWE | Self efficacy questionnaire (SWE) (Schwarzer and Jerusalem, 1995) | 2 weeks |
| Self efficacy questionnaire SWE | Self efficacy questionnaire (SWE) (Schwarzer and Jerusalem, 1995) | 24 weeks |
| Body awareness BAQ | Body awareness assessed by Body Awareness Questionnaire (BAQ) (Shields et al., 1989) | 24 weeks |
| Body awareness BRS | Body awareness assessed by Body Responsiveness Scale (BRS) (Daubenmier, 2005) | 24 weeks |
| Adverse effects | Number of participants with any adverse effect during the study period | 2 weeks |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D003109 | Colonic Diseases, Functional |