Evaluation of the Benefit Provided by Sessions of Sophrology on the Intraoperative Management of Parkinsonian Patients in the Context of Deep Brain Stimulation Surgery.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Rennes University Hospital
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Patient anxiety
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Patient anxiety
Time Frame: 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 Outcomes
- Per operative pain(Intraoperative (At the end of the first electrode placement))
- Evaluation of the anxiety(Intraoperative (At the end of the first electrode placement))
- Interaction between the patient and the surgical team during the procedure(At Day 0)
- The duration of the intervention in minutes(intraoperative)
- Heart rate(At one hour after the beginning of the intervention)
- Blood pressure(At one hour after the beginning of the intervention)
- Experience of the surgical intervention(one week after surgery)
- Experience of the perioperative period by the patient(one week after surgery)
- Occurrence adverse event(Through study completion (Day 0 to Week 1))
- Inter-group comparison of the evolution of anxiety(between the inclusion (Month -3) and the beginning of the intervention (Hour O))