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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
24
10 sessions of sophrology in preparation for the intervention 5 weeks before this one.
Rennes University Hospital
Rennes, France
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
Time frame: at one hour after the beginning of the intervention
Per operative pain
Per operative pain judged by a visual scale analogous
Time frame: intraoperative (at the beginning of the intervention)
Per operative pain
Per operative pain judged by a visual scale analogous
Time frame: at one hour after the begginnig of the intervention
Per operative pain
Per operative pain judged by a visual scale analogous
Time frame: Intraoperative (At the end of the first electrode placement)
Evaluation of the anxiety
Evaluation of the anxiety measured by the STAI YA
Time frame: At one hour before the procedure
Evaluation of the anxiety
Evaluation of the anxiety measured by the STAI YA
Time frame: 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
Time frame: At Day 0
The duration of the intervention in minutes
The duration of the intervention in minutes
Time frame: intraoperative
Heart rate
Heart rate in beat per minute
Time frame: At one hour after the beginning of the intervention
Blood pressure
Blood pressure in mmHg
Time frame: 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
Time frame: At 24 hours after surgery
Experience of the surgical intervention
experience of the surgical intervention by the patient evaluated on a visual analog scale
Time frame: one week after surgery
Experience of the perioperative period by the patient
Qualitative analysis
Time frame: one week after surgery
Occurrence adverse event
Occurrence of hematoma
Time frame: Through study completion (Day 0 to Week 1)
Occurrence adverse event
Occurrence of infection
Time frame: Through study completion (Day 0 to Week 1)
Occurrence adverse event
Occurrence of dysfunction of material
Time frame: 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
Time frame: between the inclusion (Month -3) and the beginning of the intervention (Hour O)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.