Using hypnosis for comfort during bone marrow biopsies
QUALHYBOM : Therapeutic Communication Associated With Local Anesthesia Versus Local Anesthesia During Bone Marrow Biopsy: Clinical, Controlled, Randomized, Multicenter Study
This study is testing whether hypnosis can help people feel more comfortable and less anxious during bone marrow biopsies compared to a mix of oxygen and nitrous oxide.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 3 sites (Rennes, Bretagne and 2 other locations) |
| Trial ID | NCT05178849 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of hypnosis versus an equimolar mixture of oxygen and nitrous oxide (MEOPA) for pain management during bone marrow biopsies. The study aims to enhance patient comfort and reduce anxiety associated with this invasive procedure. Participants will be randomized to receive either hypnosis or MEOPA, with the goal of assessing pain perception and overall experience during the biopsy. The trial is multicenter, involving multiple hospitals in France, and seeks to provide evidence for a potentially less invasive and more effective method of analgesia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are naive to bone marrow biopsy procedures and can provide informed consent.
Not a fit: Patients who require MEOPA for their procedure or have certain psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve patient comfort and reduce anxiety during bone marrow biopsies.
How similar studies have performed: Previous studies have shown promising results for the use of hypnosis in reducing anxiety during invasive procedures, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rennes, Bretagne and 2 other locations
- Rennes University Hospital — Rennes, Bretagne, France (Recruiting)
- Orléans Hospital — Orléans, France (Recruiting)
- Tours University Hospital — Tours, France (Recruiting)
Study contacts
- Study coordinator: Magali GRANGER, nurse
- Email: magali.granger@chu-rennes.fr
- Phone: 02 99 28 43 21
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.