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

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Marrow Biopsy
• Intervention / Treatment: Other: Hypnosis; Drug: Local anesthetic

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magali GRANGER, nurse; Phone Number: 87290 02 99 28 43 21; Email: magali.granger@chu-rennes.fr
• Study Contact Backup: Name: Thierry LAMY, MD; Email: thierry.lamy.de.la.chapelle@chu-rennes.fr

Study Locations

• France
  • Orléans, France
    • Recruiting
    • Orléans Hospital
    • Contact: Marlène OCHMANN, MD; Email: marlene.ochmann@chr-orleans.fr
    • Principal Investigator: Marlène OCHMANN, MD
  • Tours, France
    • Recruiting
    • Tours university Hospital
    • Contact: Emmanuel GYAN, MD; Email: e.gyan@chu-tours.fr
    • Principal Investigator: Emmanuel GYAN, MD
  • Bretagne
    • Rennes, Bretagne, France, 35033
      • Recruiting
      • Rennes University Hospital
      • Contact: Thierry LAMY, MD; Email: thierry.lamy.de.la.chapelle@chu-rennes.fr
      • Contact: Magali GRANGER, Nurse; Phone Number: 87 290 02 99 28 43 21; Email: magali.granger@chu-rennes.fr
      • Principal Investigator: Magali GRANGER, Nurse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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%.	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%.
Active Comparator: 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%.	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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	10 minutes (+/- 3 minutes) before the biopsy procedure and repeated immediately after the biopsy procedure (just after the pain assessment)
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.	Immediately after leaving the patient's room
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.	1 day (At BOM's gesture)
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.	Immediately after the assessment of the comfort scale
MEOPA administration	MEOPA administration or not during the gesture	Through gesture completion, an average of 45 minuts

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Estimated): June 19, 2025
• Study Completion (Estimated): June 19, 2025

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Hypnosis
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 35RC19_8879_QUALHYBOM; IDRCB (Registry Identifier: 2022-A02601-42); SI RIPH2G (Other Identifier: 23.00615.000256)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No