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Impact of Sophrology on the Pain Felt During a Bone Marrow Aspiration and Biopsy

Study of the Impact of Sophrology on the Pain Felt During a Bone Marrow Aspiration and Biopsy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04168983
Acronym
BOM-ZEN
Enrollment
90
Registered
2019-11-19
Start date
2019-09-25
Completion date
2021-09-25
Last updated
2022-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnoses Disease, Hematologic Diseases, Pain

Brief summary

The bone marrow aspiration and biopsy (BMAB) is an essential and indispensable examination for the diagnosis and the follow-up of the hematological diseases but which remains painful and dread by the patients. Until then it was performed manually using a trocar. It is now practiced most often using a tool (like a small drill), device that pierces through the external iliac bone to extract a bone cylinder that will be analyzed If the gesture is faster than with the manual method, it remains overall painful and the noise generated by the drill that passes through the periosteum of the iliac bone is impressive for the patient. Prevention measures to limit pain and anxiety are put in place during the examination: local anesthesia, with or without a lidocaine patch, as well as inhalation of a mixture of nitrous oxide and oxygen (MEOPA®). These, recommended by the Standards, Options, Recommendation (SOR) often remain insufficient and are not devoid of undesirable effects. Despite these precautions, several studies show that the action remains painful and anxiety-provoking. An exploratory survey carried out in the hematology department of the François Baclesse Center in 2013 confirms these results and specifies that the pain remains present for another 30 minutes after the examination. The investigators believe that associating a psycho-corporeal technique, as is sophrology, with the usual care, could contribute to the decrease of the threshold of pain and anxiety during the BMAB and avoid the use of a premedication. The effectiveness of sophrology as a complementary technique in the field of pain prevention in invasive procedures is recognized by observations and clinical results. This complementary therapy, among others, has its place in the hospital. To date, to investigator's knowledge, there is no published, randomized study evaluating the effectiveness of sophrology on pain in invasive procedures. The investigators propose a study whose main objective is to evaluate the effectiveness of a session of sophrology on the pain felt during the realization of the BMAB, in patients with hematological malignancy. This session will be provided by a sophrologist nurse This study should include 90 patients undergoing a BMAB over a 24-month period.

Interventions

Sophrology session provided by a nurse sophrologist in addition to the usual care during BMAB

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Single centre, comparative, controlled randomized study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient over 18 years old who has been informed of the study and has signed the consent form of the study * Patient with a malignant hemopathy requiring a BMAB as part of a diagnostic assessment * Patient who has never had a BMAB before * Patient affiliated to a social security scheme

Exclusion criteria

* Patient requiring oral premedication * Patient with contraindications or intolerance to MEOPA® * Patient with a history of allergy to local anesthetics * Patient not understanding French * Patient with deafness * Patient with severe cognitive impairment * Patient under legal protection

Design outcomes

Primary

MeasureTime frameDescription
Visual analog scale (VAS) score of the pain felt by the patient during the gesture of performing the BMABBaselineThis is a self-assessment. This scale has two sides. On one side, the patient identifies his pain with a ruler, left (no pain) right (the strongest pain he has ever felt). On the other hand, the caregiver raises the corresponding score from 0 to 10. Pain will bemeasured a posteriori (not possible to evaluate during the sophrology sesssion)

Secondary

MeasureTime frameDescription
Numerical score (NS) of anxiety of the patient before the BMABBaselineThe same scale is used to measure anxiety

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026