Effectiveness and Reliability of Hypnosis in Stereotaxy

NCT03074422 | Unknown

• 1 other identifier: 2016-01843
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Tremor, Essential; Dystonia, Primary

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (2)

• Effect on the stress perceived during the procedure

  2 years

• Effect on the incidence of post-traumatic stress disorder

  2 years

Study Arms (2)

Hypsnosis

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Hypnosis PROCEDURE

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

Hypsnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospital

Geneva, 1211 Genève 14, Switzerland

RECRUITING

Related Publications (17)

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  PMID: 24814855 BACKGROUND

• Rahman M, Murad GJ, Mocco J. Early history of the stereotactic apparatus in neurosurgery. Neurosurg Focus. 2009 Sep;27(3):E12. doi: 10.3171/2009.7.FOCUS09118.

  PMID: 19722814 BACKGROUND

• Murata J, Sawamura Y, Kitagawa M, Saito H, Kikuchi S, Tashiro K. [Minimally invasive stereotactic functional surgery using an intravenous anesthetic propofol and applying Image Fusion and AtlasPlan]. No To Shinkei. 2001 May;53(5):457-62. Japanese.

  PMID: 11424357 BACKGROUND

• Venkatraghavan L, Manninen P, Mak P, Lukitto K, Hodaie M, Lozano A. Anesthesia for functional neurosurgery: review of complications. J Neurosurg Anesthesiol. 2006 Jan;18(1):64-7. doi: 10.1097/01.ana.0000181285.71597.e8.

  PMID: 16369142 BACKGROUND

• Stokes MA, Soriano SG, Tarbell NJ, Loeffler JS, Alexander E 3rd, Black PM, Rockoff MA. Anesthesia for stereotactic radiosurgery in children. J Neurosurg Anesthesiol. 1995 Apr;7(2):100-8. doi: 10.1097/00008506-199504000-00005.

  PMID: 7772962 BACKGROUND

• Benabid AL, Chabardes S, Mitrofanis J, Pollak P. Deep brain stimulation of the subthalamic nucleus for the treatment of Parkinson's disease. Lancet Neurol. 2009 Jan;8(1):67-81. doi: 10.1016/S1474-4422(08)70291-6.

  PMID: 19081516 BACKGROUND

• Benabid AL, Chabardes S, Seigneuret E, Fraix V, Krack P, Pollak P, Xia R, Wallace B, Sauter F. Surgical therapy for Parkinson's disease. J Neural Transm Suppl. 2006;(70):383-92. doi: 10.1007/978-3-211-45295-0_58.

  PMID: 17017557 BACKGROUND

• Chevrier E, Fraix V, Krack P, Chabardes S, Benabid AL, Pollak P. Is there a role for physiotherapy during deep brain stimulation surgery in patients with Parkinson's disease? Eur J Neurol. 2006 May;13(5):496-8. doi: 10.1111/j.1468-1331.2006.01298.x.

  PMID: 16722975 BACKGROUND

• Fraix V, Pollak P, Chabardes S, Ardouin C, Koudsie A, Benazzouz A, Krack P, Batir A, Le Bas JF, Benabid AL. [Deep brain stimulation]. Rev Neurol (Paris). 2004 May;160(5 Pt 1):511-21. doi: 10.1016/s0035-3787(04)70980-7. French.

  PMID: 15269668 BACKGROUND

• Benabid AL, Pollak P, Hommel M, Gaio JM, de Rougemont J, Perret J. [Treatment of Parkinson tremor by chronic stimulation of the ventral intermediate nucleus of the thalamus]. Rev Neurol (Paris). 1989;145(4):320-3. French.

  PMID: 2660224 BACKGROUND

• Cojan Y, Waber L, Schwartz S, Rossier L, Forster A, Vuilleumier P. The brain under self-control: modulation of inhibitory and monitoring cortical networks during hypnotic paralysis. Neuron. 2009 Jun 25;62(6):862-75. doi: 10.1016/j.neuron.2009.05.021.

  PMID: 19555654 BACKGROUND

• Zemmoura I, Fournier E, El-Hage W, Jolly V, Destrieux C, Velut S. Hypnosis for Awake Surgery of Low-grade Gliomas: Description of the Method and Psychological Assessment. Neurosurgery. 2016 Jan;78(1):53-61. doi: 10.1227/NEU.0000000000000993.

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• Tykocki T, Kornakiewicz A, Mandat T, Nauman P. Pain perception in patients with Parkinson's disease. J Clin Neurosci. 2013 May;20(5):663-6. doi: 10.1016/j.jocn.2012.05.043. Epub 2013 Feb 26.

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  PMID: 15754668 BACKGROUND

• Catalano Chiuve S, Momjian S, Wolff A, Corniola MV. Effectiveness and reliability of hypnosis in stereotaxy: a randomized study. Acta Neurochir (Wien). 2024 Feb 27;166(1):112. doi: 10.1007/s00701-024-05943-0.

  PMID: 38411747 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor; Dystonic Disorders; Agnosia; Dystonia

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Marco Corniola

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Corniola

CONTACT

0795533770; marco.corniola@hcuge.ch

Sabina Catalano-Chiuvé

CONTACT

022372837; sabina.catalano@hcuge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 8, 2017
• Study Start: July 1, 2017
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2020
• Last Updated: October 29, 2018

Record last verified: 2018-10

Locations

CH (1)