Musical Intervention for the Management of Anxiety and Stress in People With Severe Mental Disorder in a Medium-stay Unit.

N/AActive Not RecruitingNCT07470346

Alejando Vargas Rubio12 enrolled

Overview

The aim of this study is to analyze the influence of music therapy on perceived anxiety and stress, as well as its effect on the recovery process in individuals with Severe Mental Disorder who are admitted to a Regional Medium-Stay Unit. The main questions to be addressed are: Can music therapy produce a significant difference in anxiety levels in people with Severe Mental Disorder? Can music therapy produce a significant effect on perceived stress in people with Severe Mental Disorder? Can music therapy lead to a significant improvement in recovery process indicators in people with Severe Mental Disorder? Can a relationship be objectively established between a reduction in anxiety and perceived stress levels and an increase in recovery process indicators? A total of 15 sessions will be carried out, and each session will last 60 minutes. The participants will select the songs, rhythms, or sounds they want to choose according to the session theme, followed by a dialogue between the participant and the nurse.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Severe Mental Disorder Severe Mental Illness

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals aged 18 years or older. * Individuals without severe hearing impairment. * Individuals without cognitive deficits that would prevent them from reading or understanding the proposed documents. * Individuals not in a state of psychopathological decompensation. Exclusion Criteria: * Individuals under 18 years of age. * Individuals with severe hearing impairment. * Individuals with cognitive deficits that prevent them from reading or understanding the proposed questionnaires. * Individuals in a state of psychopathological decompensation.

Outcomes

Primary Outcomes

STAI Questionnaire (State-Trait Anxiety Inventory)

This self-administered questionnaire assesses two aspects related to anxiety: state anxiety and trait anxiety. It consists of 20 items for each subscale (state anxiety and trait anxiety), with 4 response options ranging from 0 (Not at all) to 3 (Very much). Higher scores indicate a greater level of anxiety. The Spanish validated version shows a Cronbach's alpha of 0.9 for trait anxiety and 0.94 for state anxiety.

Time frame: This questionnaire will be administered at three time points: at baseline (day 1 of the intervention), midway through the intervention (around week 7), and at the end of the intervention (week 15).

Perceived Stress Scale (PSS) Questionnaire

This self-administered questionnaire assesses the level of perceived stress. It consists of 14 items with 5 response options ranging from 0 (Never) to 4 (Very often). Higher scores indicate a higher level of perceived stress. The validated Spanish version shows a Cronbach's alpha of 0.81

Questionnaire about the Process of Recovery (QPR-15-SP)

This self-administered questionnaire assesses changes in the different dimensions of the recovery process. It consists of 15 items, each rated on a Likert scale from 0 (Strongly disagree) to 4 (Strongly agree). Higher scores indicate a greater level of recovery. The validated Spanish version of this scale shows a McDonald's Omega coefficient of 0.93 and a Cronbach's alpha coefficient of 0.92

Secondary Outcomes

Satisfaction with the intervention received

Participants will complete a self-developed satisfaction survey to assess their level of satisfaction with the intervention. Satisfaction will be measured using a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied).

Time frame: At the end of the intervention, in week 15.