SOPHROSTIM: Evaluation of the Benefit Provided by Sessions of Sophrology on the Per Operative Management of Parkinsonian Patients Planned for a Deep Brain Stimulation Surgery.
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Patient anxiety [at one hour after the beginning of the intervention]
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 [intraoperative (at the beginning of the intervention)]
Per operative pain judged by a visual scale analogous
- Per operative pain [at one hour after the begginnig of the intervention]
Per operative pain judged by a visual scale analogous
- Per operative pain [Intraoperative (At the end of the first electrode placement)]
Per operative pain judged by a visual scale analogous
- Evaluation of the anxiety [At one hour before the procedure]
Evaluation of the anxiety measured by the STAI YA
- Evaluation of the anxiety [Intraoperative (At the end of the first electrode placement)]
Evaluation of the anxiety measured by the STAI YA
- Interaction between the patient and the surgical team during the procedure [At Day 0]
interaction is judged by a visual analogue scale to be completed by the neurologist and the neurosurgeon
- The duration of the intervention in minutes [intraoperative]
The duration of the intervention in minutes
- Heart rate [At one hour after the beginning of the intervention]
Heart rate in beat per minute
- Blood pressure [At one hour after the beginning of the intervention]
Blood pressure in mmHg
- Experience of the surgical intervention [At 24 hours after surgery]
experience of the surgical intervention by the patient evaluated on a visual analog scale
- Experience of the surgical intervention [one week after surgery]
experience of the surgical intervention by the patient evaluated on a visual analog scale
- Experience of the perioperative period by the patient [one week after surgery]
Qualitative analysis
- Occurrence adverse event [Through study completion (Day 0 to Week 1)]
Occurrence of hematoma
- Occurrence adverse event [Through study completion (Day 0 to Week 1)]
Occurrence of infection
- Occurrence adverse event [Through study completion (Day 0 to Week 1)]
Occurrence of dysfunction of material
- Inter-group comparison of the evolution of anxiety [between the inclusion (Month -3) and the beginning of the intervention (Hour O)]
Inter-group comparison of the evolution of anxiety by the STAI-YA
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patient (age greater than or equal to 18 years)
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Patient with idiopathic Parkinson's disease with programmed deep brain stimulation (VIM target, NST, single or bilateral GPI);
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Planned intervention in an awake patient (implying MOCA> 21 (Montreal Cognitive Assessment));
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Patient understanding the course of the study;
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Patient who has given informed consent in writing;
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Patient benefiting from a system of social insurance.
Exclusion Criteria:
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- Intervention under general anesthesia;
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Pregnant or nursing women;
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Major person under protective measures (safeguard of justice, curatorship and guardianship);
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Person deprived of liberty.
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Patient having already had a practice in yoga, sophrology, hypnotherapy superior or equal to 5 sessions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rennes University Hospital | Rennes | France | 35000 |
Sponsors and Collaborators
- Rennes University Hospital
Investigators
- Principal Investigator: Marc VERIN, Rennes University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 35RC16_9805