NCT05178849

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Bone Marrow Biopsy

Interventions

Type	Name	Description
OTHER	Hypnosis	Hypnosis
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%.

Timeline

• Start date: 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 across 1 country: France