Contribution of Hypnosis in Guided Hepatic Biopsy (Ap-Hy-PBH)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Contribution of Hypnosis in Guided Hepatic Biopsy

Conditions
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Ultrasound-guided Hepatic Biopsy

Intervention / Treatment
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* Behavioral: Hypnoanalgésia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with an indication for ultrasound-guided hepatic biopsy Over 18 years of age Affiliated to a social security system Exclusion Criteria History of psychiatric pathology, psychotropic or anxiolytic treatments 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis arm<br>The experimental group will receive an hypnosis session during the ultrasound-guided hepatic biopsy. | Behavioral: Hypnoanalgésia<br>* 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.<br>|
| No Intervention: Habitual Care<br>The control group will receive the usual medical management during the ultrasound-guided hepatic biopsy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound-guided hepatic biopsy, radiology, hypnosis, anxiety, pain