Evaluation of the Benefit Provided by Sessions of Sophrology on the Per Operative Management of Parkinsonian Patients Planned for a Deep Brain Stimulation Surgery.

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Benefit Provided by Sessions of Sophrology on the Intraoperative Management of Parkinsonian Patients in the Context of Deep Brain Stimulation Surgery.

Conditions
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Parkinson Disease, Deep Brain Stimulation

Intervention / Treatment
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* Behavioral: sessions of sophrology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient (age greater than or equal to 18 years) Patient with idiopathic Parkinson's disease with programmed deep brain stimulation (VIM target, NST, single or bilateral GPI); Planned intervention in an awake patient (implying MOCA> 21 (Montreal Cognitive Assessment)); Patient understanding the course of the study; Patient who has given informed consent in writing; Patient benefiting from a system of social insurance. Exclusion Criteria: - Intervention under general anesthesia; Pregnant or nursing women; Major person under protective measures (safeguard of justice, curatorship and guardianship); Person deprived of liberty. Patient having already had a practice in yoga, sophrology, hypnotherapy superior or equal to 5 sessions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Patients without sessions of sophrology<br>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. | |
| Experimental: Patients with sessions of sophrology<br>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. | Behavioral: sessions of sophrology<br>* 10 sessions of sophrology in preparation for the intervention 5 weeks before this one.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) |