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Bmgim Music Therapy Method in Reducing Stress in Patients With Inflammatory Bowel Disease

Primary Purpose

Bowel Diseases, Inflammatory, Crohn Disease, Colitis, Ulcerative

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

BMGIM Music Therapy Method

About this trial

This is an interventional supportive care trial for Bowel Diseases, Inflammatory focused on measuring Music Therapy

Eligibility Criteria

20 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Universitat de València

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

Outcomes

Primary Outcome Measures

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

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

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03999294

First Posted

June 5, 2019

Last Updated

June 25, 2019

Sponsor

University of Valencia

Collaborators

Universidad Católica de Valencia San Vicente Mártir, Hospital General Universitario de Valencia

1. Study Identification

Unique Protocol Identification Number

NCT03999294

Brief Title

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

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

April 1, 2015 (Actual)

Primary Completion Date

June 30, 2016 (Actual)

Study Completion Date

January 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Valencia

Collaborators

Universidad Católica de Valencia San Vicente Mártir, Hospital General Universitario de Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bowel Diseases, Inflammatory, Crohn Disease, Colitis, Ulcerative

Keywords

Music Therapy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

No Intervention

Arm Title

Experimental Group

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

BMGIM Music Therapy Method

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in biological markers in saliva samples using enzyme-linked immunosorbent biological markers assay (ELISA) (PRE and POST Measures).

Description

Quantifying change in biological markers in saliva samples using enzyme-linked immunosorbent assay (ELISA). (IgA level & Salivary Cortisol) comparing pre and post intervention

Time Frame