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| Name | Class |
|---|---|
| Universidad Católica de Valencia San Vicente Mártir | UNKNOWN |
| Hospital General Universitario de Valencia | OTHER |
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Inflammatory bowel disease (IBD) is a term that defines a chronic disease characterized by inflammation of the intestine. It includes ulcerative colitis (UC) and Crohn's disease (CD). The objective of the study was to administer a treatment based on a group adaptation of the BMGIM in patients with inflammatory bowel disease (IBD) and assess its impact on state of mind, quality of life, anxiety, depression, immunocompetence as a marker of well-being, and levels of acute and chronic stress.
To achieve the objectives a quasi-experimental, quantitative, qualitative, analytical, and prospective study was performed. 41 patients with IBD divided into a test group (24 patients), who received 8 sessions over 8 weeks, and a control group (17 patients). A saliva sample was taken from each patient before and after each session to determine cortisol levels (acute stress) and IgA (immunocompetence) using ELISA. A series of questionnaires were completed as follows: HADS (perceived anxiety), MOOD (state of mind), and CCVEII (quality of life). Similarly, a hair sample was taken before the first and after the last session to determine the cumulative cortisol level (chronic stress) using ELISA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | ||
| Experimental Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMGIM Music Therapy Method | Other | The BMGIM method is today one of the models recognized by the international music therapy community, deserving this distinction those approaches that develop a solid theoretical and practical body, with specific training programs as training for new therapists, and that also promote the scientific research as a way to develop the method and Music Therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in biological markers in saliva samples using enzyme-linked immunosorbent biological markers assay (ELISA) (PRE and POST Measures). | Quantifying change in biological markers in saliva samples using enzyme-linked immunosorbent assay (ELISA). (IgA level & Salivary Cortisol) comparing pre and post intervention | Baseline up to 8 weeks of treatment |
| Change in biological markers in hair using enzyme-linked immunosorbent assay (ELISA).(PRE and POST Measures). | Quantifying change in biological markers in hair (Cortisol Hair) comparing pre and post intervention | Baseline up to 8 weeks of treatment |
| Change in Hospital Anxiety and Depression Scale (HADS) (PRE and POST Measures) | 14 items. 7 items for Anxiety and 7 for Depression. The score for the items is evaluated on a Likert scale ranging from 0 to 3 points, where 0 represents never or almost never, 1 a little or from time to time, 2 somewhat less than before or not as intense, and 3 maximum or almost always. Lastly, it is worth mentioning that these scales are interpreted based on the sum of each dimension, with 21 as the maximum, both for depression and for anxiety. Higher values represent a worse outcome. Observing change comparing pre and post intervention | Baseline up to 8 weeks of treatment |
| Change in Short-form Questionnaire on Quality of Life in IBD (CCVEII-9) (PRE and POST Measures) | 9 items grouped in a single dimension The final score is expressed on a scale of 0 to 100 points, such that a lower score corresponds to a lower quality of life and vice versa. Observing change comparing pre and post intervention | Baseline up to 8 weeks of treatment |
| Change in the MOOD questionnaire (PRE and POST Measures). | The scale evaluates the frequency of the different states of mind (happiness, anger, sadness, and fear) based on 20 items (4 dimensions of 5 items each). The responses for the items were measured using a 3-point Likert scale (1=never, 2=sometimes, 3=often). Each dimension range from 1 to 3. There is not a total of all dimensions together. a lower score corresponds to high level fo that mood (lower values= a betwer outcome on anger, sadness, and fear and worst outcome on hapiness). Observing change comparing pre and post intervention |
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Inclusion Criteria:
Exclusion Criteria:
The patients who were excluded from this study were those who did not meet the requirements indicated in the inclusion criteria, or who showed aversion or rejection to this type of therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Vicente Javier Prado Gascó | Universitat de València | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat de València | Valencia | 46010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40243391 | Derived | Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2017 | Jun 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Baseline up to 8 weeks of treatment |
| D003092 | Colitis |
| D003108 | Colonic Diseases |