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Effectiveness and Reliability of Hypnosis in Stereotaxy (ERST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03074422
Recruitment Status : Unknown
Verified October 2018 by Marco Vincenzo Corniola, University Hospital, Geneva.
Recruitment status was:  Recruiting
First Posted : March 8, 2017
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Marco Vincenzo Corniola, University Hospital, Geneva

Brief Summary:
In certain neurosurgical procedures, the use of a stereotaxic frame is required. It is then possible to set a precise target (depending of the type of the surgery) to be reached by the surgeon. The fixation of the stereotactic frame on the awake patient's head is done under local anesthesia by screwing the frame directly into the skull. This procedure is reported as "painful" to "extremely painful" by patients. The objective of this study is to determine whether the hypnosis is effective in decreasing the pain perceived by the patient during the disposal of the stereotactic frame.

Condition or disease Intervention/treatment Phase
Parkinson Disease Tremor, Essential Dystonia, Primary Procedure: Hypnosis Not Applicable

Detailed Description:

The role of hypnosis (no sedative drug administered) and hypnosedative procedures (hypnosis with the adjunct of a sedative drug) during surgical procedures has been largely discussed during the past 10 years, and those techniques are now widely practiced in the surgical field, for example during thyroidectomies. In neurosurgery specifically, the successful use of hypnosedation during awake neurosurgical procedures has been recently reported, with a positive feedback from the patients, together with good results regarding extent of resection, in the case of brain lesions located in eloquent areas.

Since 1990, many research groups identified the existence of hypnosis-related phenomena and their influence on the pain signal perception. These authors show that there is a modulation of the anterior cingulate area activity together with modified interconnectivity with other critical regions involved in nociception. In this context, the potential of hypnosis in pain modulation and, more extensively, patient management in surgical anesthetics was established.

In various neurosurgical procedures, the use of a stereotactic frame is required; by using coordinates (x, y and z), which are computed and reported on the frame before the intervention, it is possible to set a precise target (dependent on the type of surgery) to be reached by the surgeon. For instance, during a Deep Brain Stimulation (DBS) performed in a patient suffering from Parkinson's disease (PD), the electrodes are introduced into the brain, deep down to the sub-thalamic nuclei (STN), which are situated in a very little area located in the upper brainstem. The mounting of the stereotactic frame on the patient's head is performed under local anesthesia (LA), as the patient is awake during the mounting procedure and later on during the surgical intervention. This mounting is done by screwing the device directly into the patient's skull, through the skin. This moment is reported as "painful" to "extremely painful" by patients, and most of them confess to keep a very unpleasant memory of the event, even several years after the procedure and despite the fact that the surgery had a positive effect on their functional outcome.

As exposed above, there is still room for improvement in the management of pain and comfort of patients undergoing functional procedures in neurosurgery, especially during the placement of the stereotactic frame. To our opinion, hypnosis could represent a serious therapy against pain and anxiety generated by the frame fixation, especially those whom facial expressions and feelings might be altered by their pathology (i.e. Parkinson's disease). In fact, this technique has already been abundantly reported as an important adjuvant to the management of pain and comfort during surgeries such as thyroidectomies) and resection of brain tumors.

The main objective of this study is to determine whether hypnosis is effective in decreasing the pain perceived by the patient during the placement of the stereotactic frame on the patient's head.

The secondary aims of this study are: 1) to measure the stress perceived during the procedure by submitting the patient to validated scores and 2) to evaluate the incidence of Post-traumatic Stress Disorder (PTSD), according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Patients will be randomly attributed to either the "hypnosis" group or the control group, by a randomization process. The investigators plan to allocate patients in two groups; in the first group, patients will undergo hypnosis during the fixation of the stereotactic frame. In the second group (control group), the frame disposal will be performed following the actual standard of care, with a LA performed during the procedure.
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: Effectiveness and Reliability of Hypnosis in Stereotaxy
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hypsnosis
During the fixation of the stereotactic frame, a single hypnosis session is performed by a certified senior anesthesiologist. Blood pressure, heart rate and respiratory rate are continuously monitored by the mean of a regular scope. Pain perceived during and after the procedure is quantifies by the mean of the Visual Analogue Scale (VAS) questionnaire. An open, standardized question will be asked to participants concerning feelings and thoughts about the frame fixation. Answers will be audio recorded. A standardized perceived distress questionnaire (PDI-13) will be performed.
Procedure: Hypnosis
Hypnosis session performed by a board certified senior anesthesiologist during the frame fixation on the patient's head.

No Intervention: Control
Local anesthesia after clear and complete information of the procedure given the day prior to the surgery. In order to determine the pain perceived during the procedure, a VAS questionnaire will be used, directly after the frame disposal. The rest of the procédure is similar to the hypnosis group.



Primary Outcome Measures :
  1. Effect on pain [ Time Frame: 2 years ]
    To determine whether the hypnosis is effective in decreasing the pain perceived by the patient during the placement of the stereotactic frame on the patient's head.


Secondary Outcome Measures :
  1. Effect on the stress perceived during the procedure [ Time Frame: 2 years ]
    To measure the stress perceived during the procedure by submitting the patient to validated scores .

  2. Effect on the incidence of post-traumatic stress disorder [ Time Frame: 2 years ]
    To evaluate the incidence of Post-traumatic Stress Disorder (PTSD), according to the DSM-IV criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing a stereotactic procedure as listed previously
  • Patients ≥ 18 y.o.

Exclusion Criteria:

  • Patients < 18 y.o.
  • Patients unable to take decisions by their own
  • Patients undergoing deep brain stimulation for obsessive-compulsive disease treatment
  • Patients refusing to participate to the study
  • Pregnancy
  • Invasive monitoring of epilepsy
  • Psychiatric comorbidity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074422


Contacts
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Contact: Marco Corniola 0795533770 ext 0041 marco.corniola@hcuge.ch
Contact: Sabina Catalano-Chiuvé 022372837 ext 0041 sabina.catalano@hcuge.ch

Locations
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Switzerland
Geneva University Hospital Recruiting
Geneva, Switzerland, 1211 Genève 14
Contact: Marco Corniola    795533770 ext 0041    marco.corniola@hcuge.ch   
Contact: Sabina Catalano    0223728317 ext 0041    sabina.catalano@hcuge.ch   
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Marco Corniola University Hospital, Geneva
Publications:

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Responsible Party: Marco Vincenzo Corniola, Chief Medical Officer, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03074422    
Other Study ID Numbers: 2016-01843
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marco Vincenzo Corniola, University Hospital, Geneva:
Functional neurosurgery
Pain management
Hypnosis
Stereotaxy
Parkinson disease
Essential tremor
Dystonia
Invasive monitoring of epilepsy
Additional relevant MeSH terms:
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Parkinson Disease
Dystonia
Dystonic Disorders
Tremor
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations