Clinical trial NCT04168983: Impact of Sophrology on the Pain Felt During a Bone Marrow Aspiration and Biopsy
Official title: Study of the Impact of Sophrology on the Pain Felt During a Bone Marrow Aspiration and Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Diseases
Diagnoses Disease
Pain
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single centre, comparative, controlled randomized study
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual analog scale (VAS) score of the pain felt by the patient during the gesture of performing the BMAB
timeFrame: Baseline
Secondary outcomes:
measure: Numerical score (NS) of anxiety of the patient before the BMAB
timeFrame: Baseline
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
affiliation: University Hospital, Caen
name: Brigitte Touchet
role: PRINCIPAL_INVESTIGATOR
References: