An interventional study of nurse semi-structured interview and Music & Relaxation with eyes closed in Depressive Disorder, Major, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-01-20.
Sponsored by Rennes University Hospital · Not applicable, Interventional, and Treatment
Repeated Transcranial Magnetic Stimulation - R.TMS - is currently part of the treatment for depressive illness. This non-invasive technique is designed to stimulate certain areas of the cerebral cortex involved in this pathology. FDA approved this treatment in routine for depressive illness. R.TMS still remains in assessment. Due to the heterogeneity of methods and the weakness of the cohorts therapeutic superiority can not concluded .
Stimulation parameters remain numerous even if a consensus is beginning to emerge. The therapeutic target is the left dorso - lateral prefrontal cortex. The lack of efficacy is probably due of the inaccuracy. The empirically location of the target does not take into account the inter-individual anatomical differences. The neuronavigation is becoming widespread in routine clinical practice.
The referent nurse stays with the patient all along the rTMS sessions. His role is to set up treatment, to ensure the safety and the well-being of the patient. An rTMS session is an average of 30 minutes and is a very special moment to create a specific therapeutic relationship.
No study was conducted to evaluate the therapeutic relationship. The assumption is made that rTMS with a semi - structured interview provides a qualitative and quantitative clinical response greater than a semi - structured rTMS without this nursing care. The investigators therefore propose to patients not receiving a semi-structured interview to listen to music with eyes closed.
Repeated Transcranial Magnetic Stimulation - R.TMS - is currently part of the treatment for depressive illness. This non-invasive technique is designed to stimulate certain areas of the cerebral cortex involved in this pathology. The Food \& Drug Administration - FDA - approved this treatment in routine for depressive illness. R.TMS still remains in assessment. Due to the heterogeneity of methods and the weakness of the cohorts therapeutic superiority can not concluded . Stimulation parameters remain numerous even if a consensus is beginning to emerge. The therapeutic target is the left dorso - lateral prefrontal cortex. The lack of efficacy is probably due of the inaccuracy. The empirically location of the target does not take into account the inter-individual anatomical differences. The neuronavigation is becoming widespread in routine clinical practice.
The referent nurse stays with the patient all along the rTMS sessions. His role is to set up treatment, to ensure the safety and the well-being of the patient. An rTMS session is an average of 30 minutes and is a very special moment to create a specific therapeutic relationship. To our knowledge, no study was conducted to evaluate the therapeutic relationship. The assumption is made that rTMS with a semi - structured interview provides a qualitative and quantitative clinical response greater than a semi - structured rTMS without this nursing care. The investigators, therefore propose to patients not receiving a semi-structured interview to listen to music with eyes closed.
Exclusion Criteria:
Repeated Transcranial Magnetic Stimulation sessions associated with nurse semi-structured interview
Other: nurse semi-structured interview
Repeated Transcranial Magnetic Stimulation sessions associated with music listening \& relaxation with eyes closed
Other: Music & Relaxation with eyes closed
The first session of rTMS is D1. From the first meeting to D14 semi -structured interviews are set up
The first session of rTMS is D1. From the first meeting to D14 music \& relaxation with eyes closed sessions are set up
score of the Montgomery-Asberg Depression Rating Scale
The ratings should be based on a clinical interview moving from broadly phrased questions about symptoms to more detailed ones which allow a precise rating of severity. The rater must decide whether the rating lies on the defined scale steps (0, 2, 4, 6) or between them (1, 3, 5). It is important to remember that it is only rare occasions that a depressed patient is encountered who cannot be rated on the items in the scale. If definite answers cannot be elicited from the patients, all relevant clues as well as information from other sources should be used as a basis for the rating in line with customary clinical practice.
Time frame: day 44
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Rennes University Hospital