Clinical trial NCT05178849: QUALHYBOM Hypnosis Versus Equimolar Mixture of Oxygen and Nitrous Oxide (MEOPA) During a Bone Marrow Biopsy: a Clinical, Controlled, Randomized, Multicenter Study
Official title: QUALHYBOM : Therapeutic Communication Associated With Local Anesthesia Versus Local Anesthesia During Bone Marrow Biopsy: Clinical, Controlled, Randomized, Multicenter Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Marrow Biopsy
Keywords: Hypnosis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, controlled, randomized, single-blind, multicenter study comparing two approaches to analgesia during BOM.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Comfort
timeFrame: 3 minutes (+/- 1 minute) after the end of the gesture, or just before MEOPA administration if applicable
Secondary outcomes:
measure: Pain visual analogue scale
timeFrame: Immediately after the assessment of the comfort scale
measure: Anxiety
timeFrame: 10 minutes (+/- 3 minutes) before the biopsy procedure and repeated immediately after the biopsy procedure (just after the pain assessment)
measure: Practitioner's comfort
timeFrame: Immediately after leaving the patient's room
measure: Number of stalls
timeFrame: 1 day (At BOM's gesture)
measure: MEOPA administration
timeFrame: Through gesture completion, an average of 45 minuts
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
state: Bretagne
city: Orléans
country: France
facility: Orléans Hospital
city: Tours
country: France
facility: Tours University Hospital
Study officials:
References: