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NCT Number: NCT04168983

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hospital

Caen, 14033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sophrology

Other

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

Primary outcomes

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

    Time frame: Baseline

    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)

Secondary outcomes

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

    Time frame: Baseline

    The same scale is used to measure anxiety

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: BOM-ZEN

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2019
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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