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

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Ultrasound-guided Hepatic Biopsy

Treatments

Behavioral: Hypnoanalgésia

Study type

Interventional

Funder types

Other

Identifiers

NCT05413174
APHP220124
2022-A00008-35 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Véronique NITSCHE, RN; Solimda SOTOU BERE

Data sourced from clinicaltrials.gov

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