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

Rennes University Hospital

Status: Terminated

Conditions: Parkinson Disease; Deep Brain Stimulation

Treatments: Behavioral: sessions of sophrology

Study type: Interventional

Funder types: Other

Identifiers

NCT03273816

35RC16_9805

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Patients without sessions of sophrology

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: sessions of sophrology