Contribution of Hypnosis in Guided Hepatic Biopsy (Ap-Hy-PBH)
NCT ID: NCT05413174
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2022-09-29
2023-06-02
Brief Summary
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Single-center randomized controlled trial.
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Detailed Description
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Data concerning the use of hypnosis during percutaneous liver biopsies are limited to clinical cases, which report an absence of pain felt, including an observation in a patient who did not receive local anesthesia because of a history of allergy to Lidocaine.
Training in attentive and benevolent patient care already allows this type of procedure to be performed under good conditions in our department. This training of about one hour, carried out internally, does not require specific means. It would therefore seem useful to see what the impact is of using Ericksonian hypnosis, a recognized and risk-free technique which would require longer specific training for the staff and would represent a cost.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Hypnosis arm
The experimental group will receive an hypnosis session during the ultrasound-guided hepatic biopsy.
Hypnoanalgésia
Use of Ericksonienne hypnosis in the medical field, aiming to dissociate the patient from the intervention in order to modify his or her perception of pain and limit anxiety.
Ericksonienne hypnosis will use during ultrasound-guided biopsy in radiology ward.
Habitual Care
The control group will receive the usual medical management during the ultrasound-guided hepatic biopsy.
No interventions assigned to this group
Interventions
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Hypnoanalgésia
Use of Ericksonienne hypnosis in the medical field, aiming to dissociate the patient from the intervention in order to modify his or her perception of pain and limit anxiety.
Ericksonienne hypnosis will use during ultrasound-guided biopsy in radiology ward.
Eligibility Criteria
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Inclusion Criteria
* Over 18 years of age
* Affiliated to a social security system
Exclusion Criteria
* Refusal to participate.
* People who do not understand and/or speak French.
* People who are deaf
* Patients with impaired cognitive abilities, evaluated by the prescribing service
* Disorders of hemostasis against percutaneous approach
* Allergy to Lidocaine
* Patient under National Health Aids
18 Years
ALL
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Véronique NITSCHE, RN
Role: STUDY_DIRECTOR
APHP
Locations
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AP-HP
Paris, , France
Countries
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References
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Froehlich F, Lamy O, Fried M, Gonvers JJ. Practice and complications of liver biopsy. Results of a nationwide survey in Switzerland. Dig Dis Sci. 1993 Aug;38(8):1480-4. doi: 10.1007/BF01308607.
Faymonville ME, Laureys S, Degueldre C, DelFiore G, Luxen A, Franck G, Lamy M, Maquet P. Neural mechanisms of antinociceptive effects of hypnosis. Anesthesiology. 2000 May;92(5):1257-67. doi: 10.1097/00000542-200005000-00013.
Eisenberg E, Konopniki M, Veitsman E, Kramskay R, Gaitini D, Baruch Y. Prevalence and characteristics of pain induced by percutaneous liver biopsy. Anesth Analg. 2003 May;96(5):1392-1396. doi: 10.1213/01.ANE.0000060453.74744.17.
Bertrand AS, Iannessi A, Buteau S, Jiang XY, Beaumont H, Grondin B, Baudin G. Effects of relaxing therapies on patient's pain during percutaneous interventional radiology procedures. Ann Palliat Med. 2018 Oct;7(4):455-462. doi: 10.21037/apm.2018.07.02. Epub 2018 Jul 20.
Adams PC, Stenn PG. Liver biopsy under hypnosis. J Clin Gastroenterol. 1992 Sep;15(2):122-4. doi: 10.1097/00004836-199209000-00008.
Kendrick C, Sliwinski J, Yu Y, Johnson A, Fisher W, Kekecs Z, Elkins G. Hypnosis for Acute Procedural Pain: A Critical Review. Int J Clin Exp Hypn. 2016;64(1):75-115. doi: 10.1080/00207144.2015.1099405.
Hauser W, Hagl M, Schmierer A, Hansen E. The Efficacy, Safety and Applications of Medical Hypnosis. Dtsch Arztebl Int. 2016 Apr 29;113(17):289-96. doi: 10.3238/arztebl.2016.0289.
Lindor KD, Bru C, Jorgensen RA, Rakela J, Bordas JM, Gross JB, Rodes J, McGill DB, Reading CC, James EM, Charboneau JW, Ludwig J, Batts KP, Zinsmeister AR. The role of ultrasonography and automatic-needle biopsy in outpatient percutaneous liver biopsy. Hepatology. 1996 May;23(5):1079-83. doi: 10.1002/hep.510230522.
Cadranel JF, Rufat P, Degos F. [Practices of transcutaneous liver biopsies in France. Results of a retrospective nationwide study]. Gastroenterol Clin Biol. 2001 Jan;25(1):77-80. French.
Alexander JA, Smith BJ. Midazolam sedation for percutaneous liver biopsy. Dig Dis Sci. 1993 Dec;38(12):2209-11. doi: 10.1007/BF01299897.
Castera L, Negre I, Samii K, Buffet C. Patient-administered nitrous oxide/oxygen inhalation provides safe and effective analgesia for percutaneous liver biopsy: a randomized placebo-controlled trial. Am J Gastroenterol. 2001 May;96(5):1553-7. doi: 10.1111/j.1572-0241.2001.03776.x.
Barat M, Ollivier C, Taibi L, Nitsche V, Sogni P, Soyer P, Parlati L, Dohan A, Abdoul H, Revel MP. Standard of care versus standard of care plus Ericksonian hypnosis for percutaneous liver biopsy: Results of a randomized control trial. Diagn Interv Imaging. 2025 Mar;106(3):93-97. doi: 10.1016/j.diii.2024.09.009. Epub 2024 Oct 2.
Other Identifiers
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APHP220124
Identifier Type: -
Identifier Source: org_study_id
2022-A00008-35
Identifier Type: OTHER
Identifier Source: secondary_id
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