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Withdrawn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
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
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
NCT ID
NCT04664907
First Posted
November 25, 2020
Last Updated
October 12, 2022
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
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
Learn more about this trial
Videomusic and Psychic Trauma
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