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Videomusic and Psychic Trauma (VIMUTRAU)

Primary Purpose

Post Traumatic Stress Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Videomusic listening
Sponsored by
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Psychic trauma, Phenomenology, Consciousness, Anxiety, Music, Videomusic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female at least 18 years of age
  • Patients diagnosed with Simple Post Traumatic Stress according to DSM 5 criteria
  • Patient able to express consent prior to participation in the study
  • Patient affiliated to or beneficiary of a social security regimen

Exclusion Criteria:

  • Other serious psychiatric pathologies
  • Serious chronic pathologies, especially neurological ones
  • Epilepsy
  • Blindness or deafness
  • Psychiatric decompensation
  • Pregnant Women
  • Patient under judicial protection (guardianship, curatorship...) or justice safeguard
  • Any other reason that, in the opinion of the investigator, could interfere with study objective evaluation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patients suffering from post traumatic stress disorder

    Arm Description

    Outcomes

    Primary Outcome Measures

    Consciousness fluidity using a questionnaire dedicated to this measure
    Consciousness fluidity will be assessed before and after videomusic listening from the scores obtained at a questionnaire Evaluating Qualitatively the Fluidity of Consciousness (EQFC). Minimum and maximum values are 1 for "Never" and 6 for "Always". For some items, 1 indicates a better outcome and for some it is the contrary.

    Secondary Outcome Measures

    Qualitative analysis of experiential phenomenological interview
    Experiential phenomenological interview will be analyzed according to qualitative analyze criteria (occurrence frequencies)
    Salience-resonances method
    Experiential phenomenological interview will be analyzed according to salience-resonance method
    Patient anxiety
    Patient anxiety level will be analyzed before and after videomusic listening thanks to State-Trait Anxiety Inventory (STAI) scale and scores obtained will be correlated with EQFC scores. For each item scores go from 1 to 4. For some of them 1 means "Not at all" and 4 "A lot" and for others it is the contrary. A global score superior to 65 indicates a high level of anxiety and a global score inferior or equal to 35 a very low level of anxiety.
    Post traumatic stress disorder phenomenological definition
    Principal component analysis will be performed to find potential correlations between population initial characteristics and improvement of consciousness fluidity after videomusic listening

    Full Information

    First Posted
    November 25, 2020
    Last Updated
    October 12, 2022
    Sponsor
    Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04664907
    Brief Title
    Videomusic and Psychic Trauma
    Acronym
    VIMUTRAU
    Official Title
    Phenomenological Crossing of the Psychic Trauma and Its Resolution. Imagination at the Heart of the Treatment: Video-music as a Metaphor for Psychological Trauma and Its Resolution.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Denied by Human Subjects Protection Board
    Study Start Date
    January 2021 (Anticipated)
    Primary Completion Date
    July 2021 (Anticipated)
    Study Completion Date
    July 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This project is interested in the flow of consciousness and its modalizations during psychological trauma (post-traumatic stress disorder) and its resolution. It is based on the premise that in PTSD, consciousness becomes more rigid, less fluid, due to the memory always imposing itself on the consciousness. The resolution of the trauma and the subsequent reduction of anxiety might improve the fluidity of consciousness and thus lead to an overall improvement in the psychological state of PTSD patients. In cases of PTSD, music has been shown to reduce anxiety from the very first session and has a very positive effect on all PTSD symptoms. In this project the following elements will be evaluated : on one hand, the changes in consciousness and its fluidity and, on the other hand, the evolution of anxiety following the listening of a new kind of work, videomusic (which associates a video scenario with music) exemplifying (metaphorizing) the trauma and its resolution.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Traumatic Stress Disorder
    Keywords
    Psychic trauma, Phenomenology, Consciousness, Anxiety, Music, Videomusic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients suffering from post traumatic stress disorder
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Videomusic listening
    Intervention Description
    Patients will attend a 8 min videomusic session and questionnaires will be performed before and after this session.
    Primary Outcome Measure Information:
    Title
    Consciousness fluidity using a questionnaire dedicated to this measure
    Description
    Consciousness fluidity will be assessed before and after videomusic listening from the scores obtained at a questionnaire Evaluating Qualitatively the Fluidity of Consciousness (EQFC). Minimum and maximum values are 1 for "Never" and 6 for "Always". For some items, 1 indicates a better outcome and for some it is the contrary.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Qualitative analysis of experiential phenomenological interview
    Description
    Experiential phenomenological interview will be analyzed according to qualitative analyze criteria (occurrence frequencies)
    Time Frame
    4 weeks
    Title
    Salience-resonances method
    Description
    Experiential phenomenological interview will be analyzed according to salience-resonance method
    Time Frame
    4 weeks
    Title
    Patient anxiety
    Description
    Patient anxiety level will be analyzed before and after videomusic listening thanks to State-Trait Anxiety Inventory (STAI) scale and scores obtained will be correlated with EQFC scores. For each item scores go from 1 to 4. For some of them 1 means "Not at all" and 4 "A lot" and for others it is the contrary. A global score superior to 65 indicates a high level of anxiety and a global score inferior or equal to 35 a very low level of anxiety.
    Time Frame
    4 weeks
    Title
    Post traumatic stress disorder phenomenological definition
    Description
    Principal component analysis will be performed to find potential correlations between population initial characteristics and improvement of consciousness fluidity after videomusic listening
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female at least 18 years of age Patients diagnosed with Simple Post Traumatic Stress according to DSM 5 criteria Patient able to express consent prior to participation in the study Patient affiliated to or beneficiary of a social security regimen Exclusion Criteria: Other serious psychiatric pathologies Serious chronic pathologies, especially neurological ones Epilepsy Blindness or deafness Psychiatric decompensation Pregnant Women Patient under judicial protection (guardianship, curatorship...) or justice safeguard Any other reason that, in the opinion of the investigator, could interfere with study objective evaluation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Manuel Dias Alves, MD
    Organizational Affiliation
    Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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