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Effectiveness and Reliability of Hypnosis in Stereotaxy (ERST)

Primary Purpose

Parkinson Disease, Tremor, Essential, Dystonia, Primary

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Hypnosis
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Functional neurosurgery, Pain management, Hypnosis, Stereotaxy, Parkinson disease, Essential tremor, Dystonia, Invasive monitoring of epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Geneva University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hypsnosis

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Effect on pain
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

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

Full Information

First Posted
March 3, 2017
Last Updated
October 25, 2018
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT03074422
Brief Title
Effectiveness and Reliability of Hypnosis in Stereotaxy
Acronym
ERST
Official Title
Effectiveness and Reliability of Hypnosis in Stereotaxy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 30, 2019 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Tremor, Essential, Dystonia, Primary
Keywords
Functional neurosurgery, Pain management, Hypnosis, Stereotaxy, Parkinson disease, Essential tremor, Dystonia, Invasive monitoring of epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypsnosis
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hypnosis
Intervention Description
Hypnosis session performed by a board certified senior anesthesiologist during the frame fixation on the patient's head.
Primary Outcome Measure Information:
Title
Effect on pain
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Effect on the stress perceived during the procedure
Description
To measure the stress perceived during the procedure by submitting the patient to validated scores .
Time Frame
2 years
Title
Effect on the incidence of post-traumatic stress disorder
Description
To evaluate the incidence of Post-traumatic Stress Disorder (PTSD), according to the DSM-IV criteria
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Corniola
Phone
0795533770
Ext
0041
Email
marco.corniola@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Sabina Catalano-Chiuvé
Phone
022372837
Ext
0041
Email
sabina.catalano@hcuge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Corniola
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geneva University Hospital
City
Geneva
ZIP/Postal Code
1211 Genève 14
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Corniola
Phone
795533770
Ext
0041
Email
marco.corniola@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Sabina Catalano
Phone
0223728317
Ext
0041
Email
sabina.catalano@hcuge.ch

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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24814855
Citation
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Effectiveness and Reliability of Hypnosis in Stereotaxy

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