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

NCT ID: NCT05178849

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-19
• Study Completion Date: 2024-10-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Hypnosis + local anesthasia

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%.

Group Type: EXPERIMENTAL

Hypnosis

Intervention Type: OTHER

Hypnosis

Local anesthetic

Intervention Type: 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%.

Local anesthesia

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%.

Group Type: ACTIVE_COMPARATOR

Local anesthetic

Intervention Type: 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%.

Interventions

Hypnosis

Hypnosis

Intervention Type: OTHER

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%.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vannes hospital

Vannes, Britanny, France

Rennes University Hospital

Rennes, Brittany Region, France

Orléans Hospital

Orléans, , France

Tours University Hospital

Tours, , France

Countries

France

Other Identifiers

IDRCB

Identifier Type: OTHER

Identifier Source: secondary_id

SI RIPH2G

Identifier Type: OTHER

Identifier Source: secondary_id

35RC19_8879_QUALHYBOM

Identifier Type: -

Identifier Source: org_study_id