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

U

University of Valencia

Status

Completed

Conditions

Colitis, Ulcerative
Bowel Diseases, Inflammatory
Crohn Disease

Treatments

Other: BMGIM Music Therapy Method

Study type

Interventional

Funder types

Other

Identifiers

NCT03999294
musicoterapia25f2015

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

20 to 69 years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

51 participants in 2 patient groups

Control Group
No Intervention group
Experimental Group
Experimental group
Treatment:
Other: BMGIM Music Therapy Method

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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