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Effectiveness and Reliability of Hypnosis in Stereotaxy

Effectiveness and Reliability of Hypnosis in Stereotaxy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03074422
Acronym
ERST
Enrollment
22
Registered
2017-03-08
Start date
2017-07-01
Completion date
2020-07-30
Last updated
2018-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dystonia, Primary, Parkinson Disease, Tremor, Essential

Keywords

Functional neurosurgery, Pain management, Hypnosis, Stereotaxy, Parkinson disease, Essential tremor, Dystonia, Invasive monitoring of epilepsy

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.

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.

Interventions

PROCEDUREHypnosis

Hypnosis session performed by a board certified senior anesthesiologist during the frame fixation on the patient's head.

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

No masking

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effect on pain2 yearsTo 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

MeasureTime frameDescription
Effect on the stress perceived during the procedure2 yearsTo measure the stress perceived during the procedure by submitting the patient to validated scores .
Effect on the incidence of post-traumatic stress disorder2 yearsTo evaluate the incidence of Post-traumatic Stress Disorder (PTSD), according to the DSM-IV criteria

Countries

Switzerland

Contacts

Primary ContactMarco Corniola
marco.corniola@hcuge.ch0795533770
Backup ContactSabina Catalano-Chiuvé
sabina.catalano@hcuge.ch022372837

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026