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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A00008-35 | Other Identifier | ID-RCB Number |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to evaluate the contribution of hypnosis on the level of pain felt by the patient during ultrasound-guided hepatic biopsy, by comparing an intervention group (hypnosis) to a control group (routine and benevolent care).
Single-center randomized controlled trial.
Hepatic Biopsy Puncture (HBP) is a very useful procedure for the assessment of chronic liver disease as well as in certain acute situations, and is also essential in oncology for the histological diagnosis of primary and secondary focal lesions. A study on the prevalence and characteristics of induced pain shows that it is a pain-generating procedure for 84% of patients and that the combination of anxiolytics and local anesthesia is insufficient. The effect of relaxing therapies was evaluated during percutaneous interventional radiology procedures. Anxiety and pain measured with visual analogue scales were significantly reduced in the group receiving support from sophrology and hypnosis . The mean evaluation of anxiety per procedure was 2.07 (95% CI, 1.48-2.82) in the group receiving relaxation therapy compared with 5.94 (95% CI, 4.62-7.22) in the other group. The mean level of pain felt was 1.83 (95% CI, 1.23-2.78) for the accompanied procedures versus 4.16 (95% CI, 2.53-6.04) without accompaniment. However, this study did not specifically look at percutaneous liver biopsy, and moreover the relaxation technique used was based on sophrology and not on an Ericksonian hypnosis approach.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypnosis arm | Experimental | The experimental group will receive an hypnosis session during the ultrasound-guided hepatic biopsy. |
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| Habitual Care | No Intervention | The control group will receive the usual medical management during the ultrasound-guided hepatic biopsy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnoanalgésia | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between groups of pain level during ultrasound-guided hepatic biopsy. | maximal pain level feel (in a scale from 0 to 10, 0 means : no pain ; 10 means :maximal pain) during the process of ultrasound-guided hepatic biopsy. | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between groups of anxiety level before the ultrasound-guided hepatic biopsy | Maximal anxiety level feel (in a scale from 0 to 10, 0 means : no anxiety ; 10 means : maximal anxiety) before the process of ultrasound-guided hepatic biopsy. | day 1 |
| Difference between groups of anxiety level during the ultrasound-guided hepatic biopsy |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Véronique NITSCHE, RN | APHP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12707140 | Background | 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. | |
| 30180736 | Background | 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. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The Clinical Study Technician will then perform the 1:1 randomization. The randomization is automatically transmitted by email to the email of the radiology technician in charge of hypnosis.
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Maximal anxiety level feel (in a scale from 0 to 10, 0 means : no anxiety ; 10 means : maximal anxiety) during the process of ultrasound-guided hepatic biopsy. |
| day 1 |
| Difference between groups of pain level one hour after the ultrasound-guided hepatic biopsy. | maximal pain level feel (in a scale from 0 to 10, 0 means : no pain ; 10 means :maximal pain) one hour following the ultrasound-guided hepatic biopsy. | day 1 |
| Pain killer consumption | Consumption of analgesic in the 24 hours following the ultrasound-guided hepatic biopsy (type of drug and cumulative doses). | day 2 |
| Acceptability of another guided hepatic biopsy | Acceptability of another ultrasound-guided hepatic biopsy (in a scale from 0 to 10, 0 means : totally refuse ; 10 means : accept without hesitation). This outcome will be collected 24 hours following the ultrasound-guided hepatic biopsy. | day 2 |
| 1401822 | Background | Adams PC, Stenn PG. Liver biopsy under hypnosis. J Clin Gastroenterol. 1992 Sep;15(2):122-4. doi: 10.1097/00004836-199209000-00008. |
| 26599994 | Background | 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. |
| 27173407 | Background | 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. |
| 8621137 | Background | 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. |
| 11275620 | Background | 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. |
| 8261822 | Background | Alexander JA, Smith BJ. Midazolam sedation for percutaneous liver biopsy. Dig Dis Sci. 1993 Dec;38(12):2209-11. doi: 10.1007/BF01299897. |
| 11374698 | Background | 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. |
| 8344104 | Background | 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. |
| 10781270 | Background | 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. |
| 39358154 | Result | 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. |