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insufficient recruitment rate
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Deep brain stimulation surgery, which consists of intracerebral implantation of electrodes, is considered one of the most effective techniques for controlling the motor fluctuations of Parkinson's disease. The particularity of this surgery is the necessity of the awakening of the patient for the correct positioning of the electrodes, it is therefore a difficult test for the patient.
Medical sophrology is an ideal strategy to optimize the comfort of the patient during the operation thanks to its anxiolytic and analgesic virtues while guaranteeing the maintenance of a good patient vigilance favoring the cooperation with the operating room team. Indeed, sophrology is a body-mediated set of techniques, at the crossroads between hypnosis and yoga, which makes it possible to find a balance between emotions, thoughts and behaviors. It has already been applied in other fields such as oncology, pain management, preparation for childbirth, and for 5 years at the CHU of Rennes for preparation for the intervention of deep brain stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients without sessions of sophrology | No Intervention | The control group is also composed of Parkinsonian patients waiting for deep brain surgery but will not have any special preparation for the procedure. They will be subjected to the same assessments at the same time as the sophrology group. | |
| Patients with sessions of sophrology | Experimental | The experimental group is composed of patients with Parkinson's waiting for deep brain surgery. They will benefit from 10 sessions of sophrology in preparation for the intervention 5 weeks before this one. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sessions of sophrology | Behavioral | 10 sessions of sophrology in preparation for the intervention 5 weeks before this one. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient anxiety | patient anxiety evaluated by the STAI-YA (State Trait Anxiety Inventory), retranscribed by a caregiver of the block, the patient being unable in practice to fill in a questionnaire at that time | at one hour after the beginning of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Per operative pain | Per operative pain judged by a visual scale analogous | intraoperative (at the beginning of the intervention) |
| Per operative pain | Per operative pain judged by a visual scale analogous |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc VERIN | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes University Hospital | Rennes | 35000 | France |
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Randomized, controlled, bi-centric (national), superiority, open-label, blind-blind (evaluator) trial comparing sophrology to routine care in preparation for deep brain stimulation. The distribution of patients will be balanced between the two groups.
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The primary endpoint is taken by a nurse who does not know the randomization arm.
| at one hour after the begginnig of the intervention |
| Per operative pain | Per operative pain judged by a visual scale analogous | Intraoperative (At the end of the first electrode placement) |
| Evaluation of the anxiety | Evaluation of the anxiety measured by the STAI YA | At one hour before the procedure |
| Evaluation of the anxiety | Evaluation of the anxiety measured by the STAI YA | Intraoperative (At the end of the first electrode placement) |
| Interaction between the patient and the surgical team during the procedure | interaction is judged by a visual analogue scale to be completed by the neurologist and the neurosurgeon | At Day 0 |
| The duration of the intervention in minutes | The duration of the intervention in minutes | intraoperative |
| Heart rate | Heart rate in beat per minute | At one hour after the beginning of the intervention |
| Blood pressure | Blood pressure in mmHg | At one hour after the beginning of the intervention |
| Experience of the surgical intervention | experience of the surgical intervention by the patient evaluated on a visual analog scale | At 24 hours after surgery |
| Experience of the surgical intervention | experience of the surgical intervention by the patient evaluated on a visual analog scale | one week after surgery |
| Experience of the perioperative period by the patient | Qualitative analysis | one week after surgery |
| Occurrence adverse event | Occurrence of hematoma | Through study completion (Day 0 to Week 1) |
| Occurrence adverse event | Occurrence of infection | Through study completion (Day 0 to Week 1) |
| Occurrence adverse event | Occurrence of dysfunction of material | Through study completion (Day 0 to Week 1) |
| Inter-group comparison of the evolution of anxiety | Inter-group comparison of the evolution of anxiety by the STAI-YA | between the inclusion (Month -3) and the beginning of the intervention (Hour O) |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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