Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT03273816
Status:
TERMINATED
Last Update Posted:
2023-02-21
First Post:
2017-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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.
Sponsor:
Rennes University Hospital
Organization:
Study Overview
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.
Status:
TERMINATED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficient recruitment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOPHROSTIM
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: