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CompletedNCT04168983BOM-ZENUpdated Mar 3, 2022

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

An interventional study of sophrology in Hematologic Diseases, Diagnoses Disease and Pain, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-03.

Sponsored by University Hospital, Caen · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hematologic Diseases
  • Diagnoses Disease
  • Pain

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03

In context

Hematologic Diseases

460 studies on the registry are indexed under Hematologic Diseases; 105 are open to participants now.

This study's enrollment of 90 is above the median of 50 across 274 interventional studies indexed under Hematologic Diseases.

Browse Hematologic Diseases studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • No intervention
    Control

    Usual care: local anesthesia + nitrous oxide and oxygen administration

  • Experimental
    Experimental

    Usual care: local anesthesia + nitrous oxide and oxygen administration In this arm : sophrology is added

    Other: sophrology

Interventions

  • Othersophrology

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

06

What researchers measure

Primary outcomes

  1. Visual analog scale (VAS) score of the pain felt by the patient during the gesture of performing the BMAB

    This 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)

    Time frame: Baseline

Secondary outcomes

  1. Numerical score (NS) of anxiety of the patient before the BMAB

    The same scale is used to measure anxiety

    Time frame: Baseline

07

Study locations

1 site
  • Caen University Hospital
    Caen, 14033, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04168983
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Nov 19, 2019
Start date
Sep 25, 2019
Primary completion
Sep 25, 2021
Completion
Sep 25, 2021
Last update
Mar 3, 2022

Study contacts

Brigitte Touchet
principal investigator · University Hospital, Caen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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