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

Bone Marrow Biopsy Clinical Trial

— QUALHYBOM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05178849
• Other study ID #: 35RC19_8879_QUALHYBOM
• Secondary ID: IDRCBSI RIPH2G
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: June 19, 2025

Study information

• Verified date: November 2023
• Source: Rennes University Hospital
• Contact: Magali GRANGER, nurse
• Phone: 02 99 28 43 21
• Email: magali.granger[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 19, 2025
• Est. primary completion date: June 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Biopsy

Intervention

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%.

Locations

Country	Name	City	State
France	Orléans Hospital	Orléans
France	Rennes University Hospital	Rennes	Bretagne
France	Tours University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	MEOPA administration	MEOPA administration or not during the gesture	Through gesture completion, an average of 45 minuts