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

NCT03273816 | Terminated

• 1 other identifier: 35RC16_9805
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Patient anxiety

  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

  at one hour after the beginning of the intervention

Secondary Outcomes (16)

• Per operative pain

  intraoperative (at the beginning of the intervention)

• Per operative pain

  at one hour after the begginnig of the intervention

• Per operative pain

  Intraoperative (At the end of the first electrode placement)

• Evaluation of the anxiety

  At one hour before the procedure

• Evaluation of the anxiety

  Intraoperative (At the end of the first electrode placement)

Study Arms (2)

Patients without sessions of sophrology

NO INTERVENTION

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

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.

Behavioral: sessions of sophrology

Interventions

sessions of sophrology BEHAVIORAL

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

Patients with sessions of sophrology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, 35000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Marc VERIN

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary endpoint is taken by a nurse who does not know the randomization arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: September 6, 2017
• Study Start: December 14, 2017
• Primary Completion: February 22, 2022
• Study Completion: March 1, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

FR (1)