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

NCT05178849 | Completed

• 3 other identifiers: 35RC19_8879_QUALHYBOMIDRCBSI RIPH2G
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 4

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.

Conditions

Bone Marrow Biopsy

Keywords

Hypnosis

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• Pain visual analogue scale

  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)

• Practitioner's comfort

  Immediately after leaving the patient's room

• Number of stalls

  1 day (At BOM's gesture)

• MEOPA administration

  Through gesture completion, an average of 45 minuts

Study Arms (2)

Hypnosis + local anesthasia

EXPERIMENTAL

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%.

Other: Hypnosis; Drug: Local anesthetic

Local anesthesia

ACTIVE COMPARATOR

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%.

Drug: Local anesthetic

Interventions

Hypnosis OTHER

Hypnosis

Hypnosis + local anesthasia

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%.

Hypnosis + local anesthasia; Local anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (4)

Vannes hospital

Vannes, Britanny, 56000, France

Location

Rennes University Hospital

Rennes, Brittany Region, 35033, France

Location

Orléans Hospital

Orléans, France

Location

Tours University Hospital

Tours, France

Location

MeSH Terms

Interventions

Hypnosis; Anesthetics, Local

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, controlled, randomized, single-blind, multicenter study comparing two approaches to analgesia during BOM.

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 5, 2022
• Study Start: June 19, 2023
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)