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Bone Marrow BiopsyQUALHYBOMNCT05178849

QUALHYBOM Hypnosis Versus Equimolar Mixture of Oxygen and Nitrous Oxide (MEOPA) During a Bone Marrow Biopsy: a Clinical, Controlled, Randomized, Multicenter Study

A study testing Hypnosis and Local anesthetic in people with Bone Marrow Biopsy, run by Rennes University Hospital at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Osteo-Medullary Biopsy (BOM) is a procedure carried out by means of a trocar and makes it possible to obtain a bone core. This gesture is usually performed by performing a local subcutaneous anesthesia at the puncture point of the postero-superior iliac crest, sometimes associated with the use of MEOPA (equimolar… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bone Marrow Biopsy
What is being tested?
Hypnosis and Local anesthetic
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
4 sitesFrance
Study dates
19 Jun 2023to 30 Oct 2024
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

  • Age ≥ 18 years old;
  • Naive patient of BOM;
  • Support at the day hospital;
  • Affiliated with a social security scheme;
  • Having signed a free, informed and written consent.

Who cannot join

  • Patients requesting that the BOM be performed under MEOPA;
  • Pregnant or breastfeeding woman;
  • Emergency surgery;
  • Patients consuming long-term opiates preoperatively;
  • Substance addiction ;
  • Patient unable to understand the rating scales;
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  • Palliative care patients;
  • Deaf and / or dumb patients;
  • Patients with psychiatric pathologies (schizophrenia, bipolarity);
  • Adult persons subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Orléans Hospital

    Orléans

  • Rennes University Hospital

    Rennes, Brittany Region, 35033

  • Tours University Hospital

    Tours

  • Vannes hospital

    Vannes, Britanny, 56000

Other trials in France

About this study

Official title: QUALHYBOM : Therapeutic Communication Associated With Local Anesthesia Versus Local Anesthesia During Bone Marrow Biopsy: Clinical, Controlled, Randomized, Multicenter Study

The Osteo-Medullary Biopsy (BOM) is a procedure carried out by means of a trocar and makes it possible to obtain a bone core. This gesture is usually performed by performing a local subcutaneous anesthesia at the puncture point of the postero-superior iliac crest, sometimes associated with the use of MEOPA (equimolar mixture of oxygen and nitrous oxide) in case of persistence a painful perception at the puncture site during the examination, in accordance with the Guide to Good Practices for Spinal Puncture of the French Society of Hematology. However, this procedure appeared to us to be insufficient to ensure optimal comfort and effective analgesia and to effectively control anxiety. The realization of the BOM under hypnosis represents an alternative which can bring additional comfort to the patient thanks to a better tolerance and a reduction in the perception of pain. During hypnosis, it has been demonstrated that the stimulation of cortical areas in sleep and in wakefulness leads to a reduction in the pain felt by the patient. Thanks to a retrospective study carried out within the hematology department of the University Hospital of Rennes, we observed a net benefit of hypnosis on the comfort and the pain felt during the realization of a bone marrow biopsy, associated with a decrease in anxiety. In addition, the number of cubicles obtained during the examination (proportional to the size of the biopsy core) was better. Obtaining more than 10 cubicles (figure required by pathologists for a quality examination) was observed in 78% of cases with hypnotic support versus 53% without hypnotic support. Finally, the sample-taking physician reported better operational comfort when accompanied by the hypnotherapist nurse.

Read the detailed description

This original project aims, on the one hand, to improve the conditions for carrying out a procedure known to be invasive and painful and, on the other hand, to ensure better quality. So far, only one randomized study has been reported on the use of hypnosis in adults during a bone marrow biopsy showing a significant improvement in the anxiety generated by this test.

Being tested
Hypnosis, Local anesthetic
Keywords
Hypnosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HypnosisOther

    Hypnosis

  • Local anestheticDrug

    For the local anesthesic, the doctor uses in both arms of the study a 20 ml vial of lidocaine hydrochloride without adrenaline for injection dosed at 2%.

Study groups in NCT05178849
Study groupRoleWhat they receive
Hypnosis + local anesthasiaExperimentalAs part of this project, local anesthesia will be supported by hypnosis in patients randomized to the "hypnosis + AL" arm, and started as soon as the patient is in prone position. Hypnosis is a particular psychological state marked by the functioning of the individual at a level of attention other than the ordinary state of consciousness. It can, under certain conditions, give the appearance of sleep or sleepwalking without sharing all of its characteristics. As part of care, hypnosis is widely used for pain control. The side effects reported are nil. One of its main benefits is improved patient comfort. One of its main benefits is improved patient comfort. For the local anesthesic, the doctor uses in both arms of the study a 20 ml vial of lidocaine hydrochloride without adrenaline for injection dosed at 2%.
Receives: Other: Hypnosis; Drug: Local anesthetic
Local anesthesiaActive comparatorFor the local anesthesic, the doctor uses in both arms of the study a 20 ml vial of lidocaine hydrochloride without adrenaline for injection dosed at 2%.
Receives: Drug: Local anesthetic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comfort

    Patient comfort will be assessed by a simple, validated digital comfort scale. This scale is graduated from "0" (no comfort) to "10" (maximum conceivable comfort). This evaluation will be carried out 3 minutes (+/- 1 minute) after the end of the gesture.

    Measured: 3 minutes (+/- 1 minute) after the end of the gesture, or just before MEOPA administration if applicable

Secondary outcomes (5)

  1. Pain visual analogue scale

    The patient's pain will be assessed by the visual analogue scale (VAS). This scale is graduated from "0" (no pain) to "10" (maximum pain imaginable). It will be performed immediately after the assessment of the comfort scale.

    Measured: Immediately after the assessment of the comfort scale

  2. Anxiety

    The anxiety felt by the patient will be assessed by a simple and validated numerical scale. This scale is graduated from "0" (no anxiety) to "10" (maximum anxiety imaginable). It will be performed 10 minutes (+/- 3 minutes) before the biopsy procedure and repeated after the biopsy procedure (just after the pain assessment).

    Measured: 10 minutes (+/- 3 minutes) before the biopsy procedure and repeated immediately after the biopsy procedure (just after the pain assessment)

  3. Practitioner's comfort

    The comfort of the practitioner during the taking of the sample will be evaluated by the simple and validated digital comfort scale. This scale is graduated from "0" (no comfort) to "10" (maximum conceivable comfort). This assessment will be performed by IDE-H immediately after leaving the patient's room.

    Measured: Immediately after leaving the patient's room

  4. Number of stalls

    The quality of the sample will be assessed by the pathology laboratory according to the number of stalls present on the biopsy: biopsies ≥ 10 stalls will be considered of sufficient quality while biopsies <10 stalls will be deemed of insufficient quality.

    Measured: 1 day (At BOM's gesture)

  5. MEOPA administration

    MEOPA administration or not during the gesture

    Measured: Through gesture completion, an average of 45 minuts

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2022
  2. Study start19 Jun 2023
  3. Primary completion30 Oct 2024
  4. Study completion30 Oct 2024

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, controlled, randomized, single-blind, multicenter study comparing two approaches to analgesia during BOM.
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05178849
Sponsor's protocol ID
35RC19_8879_QUALHYBOM
Other IDs
IDRCB, SI RIPH2G
Acronym
QUALHYBOM
Status last verified
Jun 2025
First submitted
17 Dec 2021
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Granger M, Gyan E, Ochmann M, Cherel B, Lermenier C, Moignet A, Daufresne P, Djoko S, Vallet N, Eloit M, Hameon C, Werle O, Fromenteau A, Le Canderff AL, Houot R, Rousseau C, Laviolle B, Lamy T. Hypnosis associated with local anesthesia versus local anesthesia alone during bone marrow biopsy: a randomized, controlled, multicenter study, QUALHYBOM. Support Care Cancer. 2026 Jul 22;34(8):788. doi: 10.1007/s00520-026-11005-1.

    PubMed 42484702

Questions about this trial

What is this clinical trial studying?

A study testing Hypnosis and Local anesthetic in people with Bone Marrow Biopsy, run by Rennes University Hospital at 4 sites 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 5 inclusion and 10 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 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Comfort (time frame: 3 minutes (+/- 1 minute) after the end of the gesture, or just before MEOPA administration if applicable). 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 NCT05178849, which also lists 1 linked publication.

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 26 Jun 2025.

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