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

NCT05178849 — Not applicable, Completed, 180 participants, Rennes University Hospital

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

Registry	NCT05178849, acronym QUALHYBOM
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	180 (Actual)
Sponsor	Rennes University Hospital (Other)
Conditions	Bone Marrow Biopsy
Interventions	Hypnosis, Local anesthetic (Other, drug)
Dates	start 2023-06-19, primary completion 2024-10-30, completion 2024-10-30, first posted 2022-01-05, last updated 2025-06-26
Locations	4 sites in France

-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 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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Hypnosis + local anesthasia	Experimental	Other: Hypnosis; Drug: Local anesthetic	As 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%.
Local anesthesia	Active comparator	Drug: Local anesthetic	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%.

Hypnosis (Other): Hypnosis
Local anesthetic (Drug): 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%.

+Outcome measures

Primary outcomes

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

Secondary outcomes

Pain visual analogue scale [Immediately after the assessment of the comfort 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.
Anxiety [10 minutes (+/- 3 minutes) before the biopsy procedure and repeated immediately after the biopsy procedure (just after the pain assessment)]: 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).
Practitioner's comfort [Immediately after leaving the patient's room]: 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.
Number of stalls [1 day (At BOM's gesture)]: 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.
MEOPA administration [Through gesture completion, an average of 45 minuts]: MEOPA administration or not during the gesture

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

+Locations (4)

Facility	City	Country
Vannes hospital	Vannes, Britanny	France
Rennes University Hospital	Rennes, Brittany Region	France
Orléans Hospital	Orléans	France
Tours University Hospital	Tours	France

+Publications

Results publication: 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. PMID 42484702