Clinical trial NCT03999294: Bmgim Music Therapy Method in Reducing Stress in Patients With Inflammatory Bowel Disease
Official title: The Influence of the Bmgim Music Therapy Method in the Reduction of Stress in Patients With Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis): Quantitative and Qualitative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Diseases, Inflammatory
Crohn Disease
Colitis, Ulcerative
Keywords: Music Therapy
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Universidad Católica de Valencia San Vicente Mártir
name: Hospital General Universitario de Valencia
First posted: 2019-06-26
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old,
* Diagnosed IBD (EC or UC) in the remission phase,
* They did not receive treatment with corticosteroids at least in the two months prior to the start of the study,
* They did not receive any extra pharmacological treatment,
* Attend the collaborating hospital center with the study, in this case, the University General Hospital of Valencia,
* Attend the schedule and schedule established for the study,
* Accept the conditions of participation in the study indicated in the signed informed consent prior to the start of the study
* \* Do not take corticosteroids during the 8 weeks between the pre-test and the post-test,
* \* Perform the pre-test before starting session 1 (in case of experimental group) or appointment 1 (in case of control group); and then the retest at the end of session 8 (in the case of an experimental group) or appointment with nursing after 8 weeks (in the case of a control group).
* \* In the case of the patients belonging to the experimental group, who at the end of the 8 weeks of treatment would have attended at least 6 of the 8 sessions established (and that, obligatorily, 2 of them were 1 and 8, where the shots were taken) sample and completed the questionnaires).

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.

Primary outcomes:
measure: Change in biological markers in saliva samples using enzyme-linked immunosorbent biological markers assay (ELISA) (PRE and POST Measures).
timeFrame: Baseline up to 8 weeks of treatment
measure: Change in biological markers in hair using enzyme-linked immunosorbent assay (ELISA).(PRE and POST Measures).
timeFrame: Baseline up to 8 weeks of treatment
measure: Change in Hospital Anxiety and Depression Scale (HADS) (PRE and POST Measures)
timeFrame: Baseline up to 8 weeks of treatment
measure: Change in Short-form Questionnaire on Quality of Life in IBD (CCVEII-9) (PRE and POST Measures)
timeFrame: Baseline up to 8 weeks of treatment
measure: Change in the MOOD questionnaire (PRE and POST Measures).
timeFrame: Baseline up to 8 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universitat de València
Study officials:
affiliation: Universitat de València
name: Vicente Javier Prado Gascó
role: PRINCIPAL_INVESTIGATOR
References: