Deep Brain Stimulation, Parkinson Disease
Conditions
Brief summary
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.
Interventions
BEHAVIORALsessions of sophrology
10 sessions of sophrology in preparation for the intervention 5 weeks before this one.
Sponsors
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The primary endpoint is taken by a nurse who does not know the randomization arm.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient anxiety | at one hour after the beginning of the intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the anxiety | At one hour before the procedure | Evaluation of the anxiety measured by the STAI YA |
| Interaction between the patient and the surgical team during the procedure | At Day 0 | interaction is judged by a visual analogue scale to be completed by the neurologist and the neurosurgeon |
| The duration of the intervention in minutes | intraoperative | The duration of the intervention in minutes |
| Heart rate | At one hour after the beginning of the intervention | Heart rate in beat per minute |
| Per operative pain | intraoperative (at the beginning of the intervention) | Per operative pain judged by a visual scale analogous |
| Experience of the surgical intervention | At 24 hours after surgery | experience of the surgical intervention by the patient evaluated on a visual analog scale |
| Experience of the perioperative period by the patient | one week after surgery | Qualitative analysis |
| Occurrence adverse event | Through study completion (Day 0 to Week 1) | Occurrence of hematoma |
| Inter-group comparison of the evolution of anxiety | between the inclusion (Month -3) and the beginning of the intervention (Hour O) | Inter-group comparison of the evolution of anxiety by the STAI-YA |
| Blood pressure | At one hour after the beginning of the intervention | Blood pressure in mmHg |
Countries
France
Outcome results
None listed