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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04664907
Other study ID # 2020-CHITS-07
Secondary ID 2020-A02649-30
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 2021
Est. completion date July 2021

Study information

Verified date October 2022
Source Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2021
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Videomusic listening
Patients will attend a 8 min videomusic session and questionnaires will be performed before and after this session.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
Secondary Qualitative analysis of experiential phenomenological interview Experiential phenomenological interview will be analyzed according to qualitative analyze criteria (occurrence frequencies) 4 weeks
Secondary Salience-resonances method Experiential phenomenological interview will be analyzed according to salience-resonance method 4 weeks
Secondary 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. 4 weeks
Secondary 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 4 weeks
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