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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)

Primary Purpose

Parkinson Disease, Deep Brain Stimulation

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sessions of sophrology
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rennes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Patients without sessions of sophrology

Patients with sessions of sophrology

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Per operative pain
Per operative pain judged by a visual scale analogous
Per operative pain
Per operative pain judged by a visual scale analogous
Per operative pain
Per operative pain judged by a visual scale analogous
Evaluation of the anxiety
Evaluation of the anxiety measured by the STAI YA
Evaluation of the anxiety
Evaluation of the anxiety measured by the STAI YA
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
The duration of the intervention in minutes
The duration of the intervention in minutes
Heart rate
Heart rate in beat per minute
Blood pressure
Blood pressure in mmHg
Experience of the surgical intervention
experience of the surgical intervention by the patient evaluated on a visual analog scale
Experience of the surgical intervention
experience of the surgical intervention by the patient evaluated on a visual analog scale
Experience of the perioperative period by the patient
Qualitative analysis
Occurrence adverse event
Occurrence of hematoma
Occurrence adverse event
Occurrence of infection
Occurrence adverse event
Occurrence of dysfunction of material
Inter-group comparison of the evolution of anxiety
Inter-group comparison of the evolution of anxiety by the STAI-YA

Full Information

First Posted
August 28, 2017
Last Updated
February 17, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03273816
Brief Title
Evaluation of the Benefit Provided by Sessions of Sophrology on the Per Operative Management of Parkinsonian Patients Planned for a Deep Brain Stimulation Surgery.
Acronym
SOPHROSTIM
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
insufficient recruitment rate
Study Start Date
December 14, 2017 (Actual)
Primary Completion Date
February 22, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Deep Brain Stimulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
The primary endpoint is taken by a nurse who does not know the randomization arm.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients without sessions of sophrology
Arm Type
No Intervention
Arm 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.
Arm Title
Patients with sessions of sophrology
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
sessions of sophrology
Intervention Description
10 sessions of sophrology in preparation for the intervention 5 weeks before this one.
Primary Outcome Measure Information:
Title
Patient anxiety
Description
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
Time Frame
at one hour after the beginning of the intervention
Secondary Outcome Measure Information:
Title
Per operative pain
Description
Per operative pain judged by a visual scale analogous
Time Frame
intraoperative (at the beginning of the intervention)
Title
Per operative pain
Description
Per operative pain judged by a visual scale analogous
Time Frame
at one hour after the begginnig of the intervention
Title
Per operative pain
Description
Per operative pain judged by a visual scale analogous
Time Frame
Intraoperative (At the end of the first electrode placement)
Title
Evaluation of the anxiety
Description
Evaluation of the anxiety measured by the STAI YA
Time Frame
At one hour before the procedure
Title
Evaluation of the anxiety
Description
Evaluation of the anxiety measured by the STAI YA
Time Frame
Intraoperative (At the end of the first electrode placement)
Title
Interaction between the patient and the surgical team during the procedure
Description
interaction is judged by a visual analogue scale to be completed by the neurologist and the neurosurgeon
Time Frame
At Day 0
Title
The duration of the intervention in minutes
Description
The duration of the intervention in minutes
Time Frame
intraoperative
Title
Heart rate
Description
Heart rate in beat per minute
Time Frame
At one hour after the beginning of the intervention
Title
Blood pressure
Description
Blood pressure in mmHg
Time Frame
At one hour after the beginning of the intervention
Title
Experience of the surgical intervention
Description
experience of the surgical intervention by the patient evaluated on a visual analog scale
Time Frame
At 24 hours after surgery
Title
Experience of the surgical intervention
Description
experience of the surgical intervention by the patient evaluated on a visual analog scale
Time Frame
one week after surgery
Title
Experience of the perioperative period by the patient
Description
Qualitative analysis
Time Frame
one week after surgery
Title
Occurrence adverse event
Description
Occurrence of hematoma
Time Frame
Through study completion (Day 0 to Week 1)
Title
Occurrence adverse event
Description
Occurrence of infection
Time Frame
Through study completion (Day 0 to Week 1)
Title
Occurrence adverse event
Description
Occurrence of dysfunction of material
Time Frame
Through study completion (Day 0 to Week 1)
Title
Inter-group comparison of the evolution of anxiety
Description
Inter-group comparison of the evolution of anxiety by the STAI-YA
Time Frame
between the inclusion (Month -3) and the beginning of the intervention (Hour O)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc VERIN
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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