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

March 2, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Contribution of Hypnosis in Guided Hepatic Biopsy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • AP-HP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between groups of pain level during ultrasound-guided hepatic biopsy.
Time Frame: day 1
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 during the ultrasound-guided hepatic biopsy
Time Frame: day 1
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.
Time Frame: day 1
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
Time Frame: day 2
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
Time Frame: day 2
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
Difference between groups of anxiety level before the ultrasound-guided hepatic biopsy
Time Frame: day 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Study Director: Véronique NITSCHE, RN, APHP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2022

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 2, 2023

Study Registration Dates

First Submitted

May 20, 2022

First Submitted That Met QC Criteria

June 7, 2022

First Posted (Actual)

June 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP220124
  • 2022-A00008-35 (Other Identifier: ID-RCB Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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