- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04664907
Videomusic and Psychic Trauma (VIMUTRAU)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Patients suffering from post traumatic stress disorder
|
Patients will attend a 8 min videomusic session and questionnaires will be performed before and after this session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Consciousness fluidity using a questionnaire dedicated to this measure
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative analysis of experiential phenomenological interview
Time Frame: 4 weeks
|
Experiential phenomenological interview will be analyzed according to qualitative analyze criteria (occurrence frequencies)
|
4 weeks
|
Salience-resonances method
Time Frame: 4 weeks
|
Experiential phenomenological interview will be analyzed according to salience-resonance method
|
4 weeks
|
Patient anxiety
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Post traumatic stress disorder phenomenological definition
Time Frame: 4 weeks
|
Principal component analysis will be performed to find potential correlations between population initial characteristics and improvement of consciousness fluidity after videomusic listening
|
4 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-CHITS-07
- 2020-A02649-30 (OTHER: Id-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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