Impact of Sophrology on the Pain Felt During a Bone Marrow Aspiration and Biopsy (BOM-ZEN)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Hematologic Diseases; Diagnoses Disease
• Intervention / Treatment: Other: sophrology

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • CAEN University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Sophrology session provided by a nurse sophrologist in addition to the usual care during BMAB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical score (NS) of anxiety of the patient before the BMAB	The same scale is used to measure anxiety	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Brigitte Touchet, University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 25, 2019
• Primary Completion (ACTUAL): September 25, 2021
• Study Completion (ACTUAL): September 25, 2021

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: November 17, 2019
• First Posted (ACTUAL): November 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases
• Other Study ID Numbers: 2019-A00796-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No