Ultrasound-guided Hepatic BiopsyAp-Hy-PBHNCT05413174
Contribution of Hypnosis in Guided Hepatic Biopsy (Ap-Hy-PBH)
A study testing Hypnoanalgésia in people with Ultrasound-guided Hepatic Biopsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound-guided Hepatic Biopsy
- What is being tested?
- Hypnoanalgésia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2022to 2 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an indication for ultrasound-guided hepatic biopsy
- Over 18 years of age
- Affiliated to a social security system
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ultrasound-guided Hepatic Biopsy
- Being tested
- Hypnoanalgésia
- Keywords
- ultrasound-guided hepatic biopsy, radiology, hypnosis, anxiety, pain
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnoanalgésiaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis arm | Experimental | The experimental group will receive an hypnosis session during the ultrasound-guided hepatic biopsy. Receives: Behavioral: Hypnoanalgésia |
| Habitual Care | No intervention | The control group will receive the usual medical management during the ultrasound-guided hepatic biopsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: day 1
Pain killer consumption
Consumption of analgesic in the 24 hours following the ultrasound-guided hepatic biopsy (type of drug and cumulative doses).
Measured: 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.
Measured: day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start29 Sep 2022
- Primary completion1 Jun 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Ultrasound-guided Hepatic BiopsyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Véronique NITSCHE, RN, Study director, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413174
- Sponsor's protocol ID
- APHP220124
- Other IDs
- 2022-A00008-35
- Acronym
- Ap-Hy-PBH
- Status last verified
- Mar 2026
- First submitted
- 20 May 2022
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eisenberg E, Konopniki M, Veitsman E, Kramskay R, Gaitini D, Baruch Y. Prevalence and characteristics of pain induced by percutaneous liver biopsy. Anesth Analg. 2003 May;96(5):1392-1396. doi: 10.1213/01.ANE.0000060453.74744.17.
PubMed 12707140Bertrand AS, Iannessi A, Buteau S, Jiang XY, Beaumont H, Grondin B, Baudin G. Effects of relaxing therapies on patient's pain during percutaneous interventional radiology procedures. Ann Palliat Med. 2018 Oct;7(4):455-462. doi: 10.21037/apm.2018.07.02. Epub 2018 Jul 20.
PubMed 30180736Adams PC, Stenn PG. Liver biopsy under hypnosis. J Clin Gastroenterol. 1992 Sep;15(2):122-4. doi: 10.1097/00004836-199209000-00008.
PubMed 1401822Kendrick C, Sliwinski J, Yu Y, Johnson A, Fisher W, Kekecs Z, Elkins G. Hypnosis for Acute Procedural Pain: A Critical Review. Int J Clin Exp Hypn. 2016;64(1):75-115. doi: 10.1080/00207144.2015.1099405.
PubMed 26599994Hauser W, Hagl M, Schmierer A, Hansen E. The Efficacy, Safety and Applications of Medical Hypnosis. Dtsch Arztebl Int. 2016 Apr 29;113(17):289-96. doi: 10.3238/arztebl.2016.0289.
PubMed 27173407Lindor KD, Bru C, Jorgensen RA, Rakela J, Bordas JM, Gross JB, Rodes J, McGill DB, Reading CC, James EM, Charboneau JW, Ludwig J, Batts KP, Zinsmeister AR. The role of ultrasonography and automatic-needle biopsy in outpatient percutaneous liver biopsy. Hepatology. 1996 May;23(5):1079-83. doi: 10.1002/hep.510230522.
PubMed 8621137Cadranel JF, Rufat P, Degos F. [Practices of transcutaneous liver biopsies in France. Results of a retrospective nationwide study]. Gastroenterol Clin Biol. 2001 Jan;25(1):77-80. French.
PubMed 11275620Alexander JA, Smith BJ. Midazolam sedation for percutaneous liver biopsy. Dig Dis Sci. 1993 Dec;38(12):2209-11. doi: 10.1007/BF01299897.
PubMed 8261822Castera L, Negre I, Samii K, Buffet C. Patient-administered nitrous oxide/oxygen inhalation provides safe and effective analgesia for percutaneous liver biopsy: a randomized placebo-controlled trial. Am J Gastroenterol. 2001 May;96(5):1553-7. doi: 10.1111/j.1572-0241.2001.03776.x.
PubMed 11374698Froehlich F, Lamy O, Fried M, Gonvers JJ. Practice and complications of liver biopsy. Results of a nationwide survey in Switzerland. Dig Dis Sci. 1993 Aug;38(8):1480-4. doi: 10.1007/BF01308607.
PubMed 8344104Faymonville ME, Laureys S, Degueldre C, DelFiore G, Luxen A, Franck G, Lamy M, Maquet P. Neural mechanisms of antinociceptive effects of hypnosis. Anesthesiology. 2000 May;92(5):1257-67. doi: 10.1097/00000542-200005000-00013.
PubMed 10781270Barat M, Ollivier C, Taibi L, Nitsche V, Sogni P, Soyer P, Parlati L, Dohan A, Abdoul H, Revel MP. Standard of care versus standard of care plus Ericksonian hypnosis for percutaneous liver biopsy: Results of a randomized control trial. Diagn Interv Imaging. 2025 Mar;106(3):93-97. doi: 10.1016/j.diii.2024.09.009. Epub 2024 Oct 2.
PubMed 39358154
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Hypnosis in Guided Hepatic Biopsy
- ClinicalTrials.gov ID
- NCT05413174
- Acronym / sponsor ID
- Ap-Hy-PBH / APHP220124
- Conditions
- Ultrasound-guided Hepatic Biopsy
- Keywords
- ultrasound-guided hepatic biopsy, radiology, hypnosis, anxiety, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis arm | Experimental | Behavioral: HypnoanalgésiaThe experimental group will receive an hypnosis session during the ultrasound-guided hepatic biopsy. |
| Habitual Care | No intervention | –The control group will receive the usual medical management during the ultrasound-guided hepatic biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with an indication for ultrasound-guided hepatic biopsy
- Over 18 years of age
- Affiliated to a social security system
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnoanalgésiaUse 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. | Behavioural | Hypnosis arm |
Primary outcome
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.
5 secondary outcomes
Difference between groups of anxiety level before the ultrasound-guided hepatic biopsy
Time frame: day 1
Difference between groups of anxiety level during the ultrasound-guided hepatic biopsy
Time frame: day 1
Difference between groups of pain level one hour after the ultrasound-guided hepatic biopsy.
Time frame: day 1
Pain killer consumption
Time frame: day 2
Acceptability of another guided hepatic biopsy
Time frame: day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 12707140Eisenberg E, Konopniki M, Veitsman E, Kramskay R, Gaitini D, Baruch Y. Prevalence and characteristics of pain induced by percutaneous liver biopsy. Anesth Analg. 2003 May;96(5):1392-1396. doi: 10.1213/01.ANE.0000060453.74744.17.
- Background: PubMed 30180736Bertrand AS, Iannessi A, Buteau S, Jiang XY, Beaumont H, Grondin B, Baudin G. Effects of relaxing therapies on patient's pain during percutaneous interventional radiology procedures. Ann Palliat Med. 2018 Oct;7(4):455-462. doi: 10.21037/apm.2018.07.02. Epub 2018 Jul 20.
- Background: PubMed 1401822Adams PC, Stenn PG. Liver biopsy under hypnosis. J Clin Gastroenterol. 1992 Sep;15(2):122-4. doi: 10.1097/00004836-199209000-00008.
- Background: PubMed 26599994Kendrick C, Sliwinski J, Yu Y, Johnson A, Fisher W, Kekecs Z, Elkins G. Hypnosis for Acute Procedural Pain: A Critical Review. Int J Clin Exp Hypn. 2016;64(1):75-115. doi: 10.1080/00207144.2015.1099405.
- Background: PubMed 27173407Hauser W, Hagl M, Schmierer A, Hansen E. The Efficacy, Safety and Applications of Medical Hypnosis. Dtsch Arztebl Int. 2016 Apr 29;113(17):289-96. doi: 10.3238/arztebl.2016.0289.
- Background: PubMed 8621137Lindor KD, Bru C, Jorgensen RA, Rakela J, Bordas JM, Gross JB, Rodes J, McGill DB, Reading CC, James EM, Charboneau JW, Ludwig J, Batts KP, Zinsmeister AR. The role of ultrasonography and automatic-needle biopsy in outpatient percutaneous liver biopsy. Hepatology. 1996 May;23(5):1079-83. doi: 10.1002/hep.510230522.
- Background: PubMed 11275620Cadranel JF, Rufat P, Degos F. [Practices of transcutaneous liver biopsies in France. Results of a retrospective nationwide study]. Gastroenterol Clin Biol. 2001 Jan;25(1):77-80. French.
- Background: PubMed 8261822Alexander JA, Smith BJ. Midazolam sedation for percutaneous liver biopsy. Dig Dis Sci. 1993 Dec;38(12):2209-11. doi: 10.1007/BF01299897.
- Background: PubMed 11374698Castera L, Negre I, Samii K, Buffet C. Patient-administered nitrous oxide/oxygen inhalation provides safe and effective analgesia for percutaneous liver biopsy: a randomized placebo-controlled trial. Am J Gastroenterol. 2001 May;96(5):1553-7. doi: 10.1111/j.1572-0241.2001.03776.x.
- Background: PubMed 8344104Froehlich F, Lamy O, Fried M, Gonvers JJ. Practice and complications of liver biopsy. Results of a nationwide survey in Switzerland. Dig Dis Sci. 1993 Aug;38(8):1480-4. doi: 10.1007/BF01308607.
- Background: PubMed 10781270Faymonville ME, Laureys S, Degueldre C, DelFiore G, Luxen A, Franck G, Lamy M, Maquet P. Neural mechanisms of antinociceptive effects of hypnosis. Anesthesiology. 2000 May;92(5):1257-67. doi: 10.1097/00000542-200005000-00013.
- Results publication: PubMed 39358154Barat M, Ollivier C, Taibi L, Nitsche V, Sogni P, Soyer P, Parlati L, Dohan A, Abdoul H, Revel MP. Standard of care versus standard of care plus Ericksonian hypnosis for percutaneous liver biopsy: Results of a randomized control trial. Diagn Interv Imaging. 2025 Mar;106(3):93-97. doi: 10.1016/j.diii.2024.09.009. Epub 2024 Oct 2.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Véronique NITSCHE, RN study director
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnoanalgésia in people with Ultrasound-guided Hepatic Biopsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between groups of pain level during ultrasound-guided hepatic biopsy. (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05413174, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.