Effectiveness and Reliability of Hypnosis in Stereotaxy (ERST)
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|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
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Tremor, Essential Dystonia, Primary||Procedure: Hypnosis||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|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|
|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|
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.
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.
- 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.
- 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 .
- 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
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
|Contact: Marco Corniola||0795533770 ext firstname.lastname@example.org|
|Contact: Sabina Catalano-Chiuvé||022372837 ext email@example.com|
|Principal Investigator:||Marco Corniola||University Hospital, Geneva|