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

Parkinson Disease Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03273816
• Other study ID #: 35RC16_9805
• Status: Terminated
• Phase: N/A
• Start date: December 14, 2017
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: March 1, 2022
• Est. primary completion date: February 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Parkinson Disease

Intervention

Behavioral:
• sessions of sophrology
10 sessions of sophrology in preparation for the intervention 5 weeks before this one.

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Per operative pain	Per operative pain judged by a visual scale analogous	intraoperative (at the beginning of the intervention)
Secondary	Per operative pain	Per operative pain judged by a visual scale analogous	at one hour after the begginnig of the intervention
Secondary	Per operative pain	Per operative pain judged by a visual scale analogous	Intraoperative (At the end of the first electrode placement)
Secondary	Evaluation of the anxiety	Evaluation of the anxiety measured by the STAI YA	At one hour before the procedure
Secondary	Evaluation of the anxiety	Evaluation of the anxiety measured by the STAI YA	Intraoperative (At the end of the first electrode placement)
Secondary	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
Secondary	The duration of the intervention in minutes	The duration of the intervention in minutes	intraoperative
Secondary	Heart rate	Heart rate in beat per minute	At one hour after the beginning of the intervention
Secondary	Blood pressure	Blood pressure in mmHg	At one hour after the beginning of the intervention
Secondary	Experience of the surgical intervention	experience of the surgical intervention by the patient evaluated on a visual analog scale	At 24 hours after surgery
Secondary	Experience of the surgical intervention	experience of the surgical intervention by the patient evaluated on a visual analog scale	one week after surgery
Secondary	Experience of the perioperative period by the patient	Qualitative analysis	one week after surgery
Secondary	Occurrence adverse event	Occurrence of hematoma	Through study completion (Day 0 to Week 1)
Secondary	Occurrence adverse event	Occurrence of infection	Through study completion (Day 0 to Week 1)
Secondary	Occurrence adverse event	Occurrence of dysfunction of material	Through study completion (Day 0 to Week 1)
Secondary	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)