Clinical trial NCT05413174: Contribution of Hypnosis in Guided Hepatic Biopsy (Ap-Hy-PBH)
Official title: Contribution of Hypnosis in Guided Hepatic Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound-guided Hepatic Biopsy
Keywords: ultrasound-guided hepatic biopsy
radiology
hypnosis
anxiety
pain
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Difference between groups of pain level during ultrasound-guided hepatic biopsy.
timeFrame: day 1
Secondary outcomes:
measure: Difference between groups of anxiety level before the ultrasound-guided hepatic biopsy
timeFrame: day 1
measure: Difference between groups of anxiety level during the ultrasound-guided hepatic biopsy
timeFrame: day 1
measure: Difference between groups of pain level one hour after the ultrasound-guided hepatic biopsy.
timeFrame: day 1
measure: Pain killer consumption
timeFrame: day 2
measure: Acceptability of another guided hepatic biopsy
timeFrame: day 2
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP
Study officials:
affiliation: APHP
name: Véronique NITSCHE, RN
role: STUDY_DIRECTOR
References:
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