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)

Evaluation of the Benefit Provided by Sessions of Sophrology on the Intraoperative Management of Parkinsonian Patients in the Context of Deep Brain Stimulation Surgery.

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.

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease; Deep Brain Stimulation
• Intervention / Treatment: Behavioral: sessions of sophrology

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: sessions of sophrology; 10 sessions of sophrology in preparation for the intervention 5 weeks before this one.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Per operative pain	Per operative pain judged by a visual scale analogous	intraoperative (at the beginning of the intervention)
Per operative pain	Per operative pain judged by a visual scale analogous	at one hour after the begginnig of the intervention
Per operative pain	Per operative pain judged by a visual scale analogous	Intraoperative (At the end of the first electrode placement)
Evaluation of the anxiety	Evaluation of the anxiety measured by the STAI YA	At one hour before the procedure
Evaluation of the anxiety	Evaluation of the anxiety measured by the STAI YA	Intraoperative (At the end of the first electrode placement)
Interaction between the patient and the surgical team during the procedure	interaction is judged by a visual analogue scale to be completed by the neurologist and the neurosurgeon	At Day 0
The duration of the intervention in minutes	The duration of the intervention in minutes	intraoperative
Heart rate	Heart rate in beat per minute	At one hour after the beginning of the intervention
Blood pressure	Blood pressure in mmHg	At one hour after the beginning of the intervention
Experience of the surgical intervention	experience of the surgical intervention by the patient evaluated on a visual analog scale	At 24 hours after surgery
Experience of the surgical intervention	experience of the surgical intervention by the patient evaluated on a visual analog scale	one week after surgery
Experience of the perioperative period by the patient	Qualitative analysis	one week after surgery
Occurrence adverse event	Occurrence of hematoma	Through study completion (Day 0 to Week 1)
Occurrence adverse event	Occurrence of infection	Through study completion (Day 0 to Week 1)
Occurrence adverse event	Occurrence of dysfunction of material	Through study completion (Day 0 to Week 1)
Inter-group comparison of the evolution of anxiety	Inter-group comparison of the evolution of anxiety by the STAI-YA	between the inclusion (Month -3) and the beginning of the intervention (Hour O)

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2017
• Primary Completion (Actual): February 22, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: September 4, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 35RC16_9805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No