Skip to main content
Clinical Trials/NCT05413174
NCT05413174CompletedNot Applicable

Contribution of Hypnosis in Guided Hepatic Biopsy

Assistance Publique - Hôpitaux de Paris1 site in 1 country70 target enrollmentStarted: September 29, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
70
Locations
1
Primary Endpoint
Difference between groups of pain level during ultrasound-guided hepatic biopsy.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Hypnosis arm

Experimental

The experimental group will receive an hypnosis session during the ultrasound-guided hepatic biopsy.

Intervention: Hypnoanalgésia (Behavioral)

Habitual Care

No Intervention

The control group will receive the usual medical management during the ultrasound-guided hepatic biopsy.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Acceptability of another guided hepatic biopsy(day 2)
  • Difference between groups of anxiety level during the ultrasound-guided hepatic biopsy(day 1)
  • Difference between groups of pain level one hour after the ultrasound-guided hepatic biopsy.(day 1)
  • Pain killer consumption(day 2)
  • Difference between groups of anxiety level before the ultrasound-guided hepatic biopsy(day 1)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Contribution of Hypnosis in Guided Hepatic... | Clinical Trial