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

NCT04168983 | Completed

• 1 other identifier: 2019-A00796-51
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Diseases; Diagnoses Disease; Pain

Outcome Measures

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)

  Baseline

Secondary Outcomes (1)

• Numerical score (NS) of anxiety of the patient before the BMAB

  Baseline

Study Arms (2)

Control

NO INTERVENTION

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

sophrology OTHER

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

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, 14033, France

Location

MeSH Terms

Conditions

Hematologic Diseases; Pain

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brigitte Touchet

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single centre, comparative, controlled randomized study

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: November 19, 2019
• Study Start: September 25, 2019
• Primary Completion: September 25, 2021
• Study Completion: September 25, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)