Clinical trial NCT03273816: Evaluation of the Benefit Provided by Sessions of Sophrology on the Per Operative Management of Parkinsonian Patients Planned for a Deep Brain Stimulation Surgery.
Official title: Evaluation of the Benefit Provided by Sessions of Sophrology on the Intraoperative Management of Parkinsonian Patients in the Context of Deep Brain Stimulation Surgery.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Deep Brain Stimulation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Patient anxiety
timeFrame: at one hour after the beginning of the intervention
Secondary outcomes:
measure: Per operative pain
timeFrame: intraoperative (at the beginning of the intervention)
measure: Per operative pain
timeFrame: at one hour after the begginnig of the intervention
measure: Per operative pain
timeFrame: Intraoperative (At the end of the first electrode placement)
measure: Evaluation of the anxiety
timeFrame: At one hour before the procedure
measure: Evaluation of the anxiety
timeFrame: Intraoperative (At the end of the first electrode placement)
measure: Interaction between the patient and the surgical team during the procedure
timeFrame: At Day 0
measure: The duration of the intervention in minutes
timeFrame: intraoperative
measure: Heart rate
timeFrame: At one hour after the beginning of the intervention
measure: Blood pressure
timeFrame: At one hour after the beginning of the intervention
measure: Experience of the surgical intervention
timeFrame: At 24 hours after surgery
measure: Experience of the surgical intervention
timeFrame: one week after surgery
measure: Experience of the perioperative period by the patient
timeFrame: one week after surgery
measure: Occurrence adverse event
timeFrame: Through study completion (Day 0 to Week 1)
measure: Occurrence adverse event
timeFrame: Through study completion (Day 0 to Week 1)
measure: Occurrence adverse event
timeFrame: Through study completion (Day 0 to Week 1)
measure: Inter-group comparison of the evolution of anxiety
timeFrame: between the inclusion (Month -3) and the beginning of the intervention (Hour O)
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Rennes University Hospital
name: Marc VERIN
role: PRINCIPAL_INVESTIGATOR
References: