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Completed

NCT Number: NCT05178849

QUALHYBOM Hypnosis Versus Equimolar Mixture of Oxygen and Nitrous Oxide (MEOPA) During a Bone Marrow Biopsy: a 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vannes hospital, Vannes, Britanny, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypnosis

Other

Hypnosis

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%.

Primary outcomes

  1. Comfort

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

    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.

Secondary outcomes

  1. Pain visual analogue scale

    Time frame: Immediately after the assessment of the comfort 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.

  2. Anxiety

    Time frame: 10 minutes (+/- 3 minutes) before the biopsy procedure and repeated immediately after the biopsy procedure (just after the pain assessment)

    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).

  3. Practitioner's comfort

    Time frame: Immediately after leaving the patient's room

    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.

  4. Number of stalls

    Time frame: 1 day (At BOM's gesture)

    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.

  5. MEOPA administration

    Time frame: Through gesture completion, an average of 45 minuts

    MEOPA administration or not during the gesture

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: QUALHYBOM

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2022
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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