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

NCT ID: NCT03273816

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-14
• Study Completion Date: 2022-03-01

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.

Conditions

Parkinson Disease; Deep Brain Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Patients without sessions of sophrology

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Patients with sessions of sophrology

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.

Group Type: EXPERIMENTAL

sessions of sophrology

Intervention Type: BEHAVIORAL

10 sessions of sophrology in preparation for the intervention 5 weeks before this one.

Interventions

sessions of sophrology

10 sessions of sophrology in preparation for the intervention 5 weeks before this one.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc VERIN

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Rennes University Hospital

Rennes, , France

Countries

France

Other Identifiers

35RC16_9805

Identifier Type: -

Identifier Source: org_study_id