Parkinson DiseaseSOPHROSTIMNCT03273816
Evaluation of the Benefit Provided by Sessions of Sophrology on the Per Operative Management of Parkinsonian Patients Planned for a Deep Brain Stimulation Surgery.
A study testing sessions of sophrology in people with Parkinson Disease and Deep Brain Stimulation, run by Rennes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Deep Brain Stimulation
- What is being tested?
- sessions of sophrology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2017to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Parkinson Disease, Deep Brain Stimulation
- Being tested
- sessions of sophrology
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sessions of sophrologyBehavioural
10 sessions of sophrology in preparation for the intervention 5 weeks before this one.
| Study group | Role | What they receive |
|---|---|---|
| Patients without sessions of sophrology | No intervention | 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. |
| Patients with sessions of sophrology | Experimental | 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. Receives: Behavioral: sessions of sophrology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at one hour after the beginning of the intervention
Secondary outcomes (16)
Per operative pain
Per operative pain judged by a visual scale analogous
Measured: intraoperative (at the beginning of the intervention)
Per operative pain
Per operative pain judged by a visual scale analogous
Measured: at one hour after the begginnig of the intervention
Per operative pain
Per operative pain judged by a visual scale analogous
Measured: Intraoperative (At the end of the first electrode placement)
Evaluation of the anxiety
Evaluation of the anxiety measured by the STAI YA
Measured: At one hour before the procedure
Evaluation of the anxiety
Evaluation of the anxiety measured by the STAI YA
Measured: 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
Measured: At Day 0
The duration of the intervention in minutes
The duration of the intervention in minutes
Measured: intraoperative
Heart rate
Heart rate in beat per minute
Measured: At one hour after the beginning of the intervention
Blood pressure
Blood pressure in mmHg
Measured: 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
Measured: At 24 hours after surgery
Experience of the surgical intervention
experience of the surgical intervention by the patient evaluated on a visual analog scale
Measured: one week after surgery
Experience of the perioperative period by the patient
Qualitative analysis
Measured: one week after surgery
Occurrence adverse event
Occurrence of hematoma
Measured: Through study completion (Day 0 to Week 1)
Occurrence adverse event
Occurrence of infection
Measured: Through study completion (Day 0 to Week 1)
Occurrence adverse event
Occurrence of dysfunction of material
Measured: 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
Measured: between the inclusion (Month -3) and the beginning of the intervention (Hour O)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start14 Dec 2017
- Primary completion22 Feb 2022
- Study completion1 Mar 2022
Why it stopped: insufficient recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc VERIN, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273816
- Sponsor's protocol ID
- 35RC16_9805
- Acronym
- SOPHROSTIM
- Status last verified
- Feb 2023
- First submitted
- 28 Aug 2017
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03273816
- Acronym / sponsor ID
- SOPHROSTIM / 35RC16_9805
- Conditions
- Parkinson Disease, Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment rate
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients without sessions of sophrology | No intervention | –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. |
| Patients with sessions of sophrology | Experimental | Behavioral: sessions of sophrologyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sessions of sophrology10 sessions of sophrology in preparation for the intervention 5 weeks before this one. | Behavioural | Patients with sessions of sophrology |
Primary outcome
Patient anxiety
Time frame: 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
16 secondary outcomes
Per operative pain
Time frame: intraoperative (at the beginning of the intervention)
Per operative pain
Time frame: at one hour after the begginnig of the intervention
Per operative pain
Time frame: Intraoperative (At the end of the first electrode placement)
Evaluation of the anxiety
Time frame: At one hour before the procedure
Evaluation of the anxiety
Time frame: Intraoperative (At the end of the first electrode placement)
Interaction between the patient and the surgical team during the procedure
Time frame: At Day 0
The duration of the intervention in minutes
Time frame: intraoperative
Heart rate
Time frame: At one hour after the beginning of the intervention
Blood pressure
Time frame: At one hour after the beginning of the intervention
Experience of the surgical intervention
Time frame: At 24 hours after surgery
Experience of the surgical intervention
Time frame: one week after surgery
Experience of the perioperative period by the patient
Time frame: one week after surgery
Occurrence adverse event
Time frame: Through study completion (Day 0 to Week 1)
Occurrence adverse event
Time frame: Through study completion (Day 0 to Week 1)
Occurrence adverse event
Time frame: Through study completion (Day 0 to Week 1)
Inter-group comparison of the evolution of anxiety
Time frame: between the inclusion (Month -3) and the beginning of the intervention (Hour O)
Results and safety
The study was stopped early (reason given: insufficient recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc VERIN principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sessions of sophrology in people with Parkinson Disease and Deep Brain Stimulation, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient anxiety (time frame: at one hour after the beginning of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.