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

Primary Purpose

Hematologic Diseases, Diagnoses Disease, Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sophrology
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hematologic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Caen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Experimental

Arm Description

Usual care: local anesthesia + nitrous oxide and oxygen administration

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Numerical score (NS) of anxiety of the patient before the BMAB
The same scale is used to measure anxiety

Full Information

First Posted
October 3, 2019
Last Updated
March 2, 2022
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT04168983
Brief Title
Impact of Sophrology on the Pain Felt During a Bone Marrow Aspiration and Biopsy
Acronym
BOM-ZEN
Official Title
Study of the Impact of Sophrology on the Pain Felt During a Bone Marrow Aspiration and Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 25, 2019 (Actual)
Primary Completion Date
September 25, 2021 (Actual)
Study Completion Date
September 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Diseases, Diagnoses Disease, Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single centre, comparative, controlled randomized study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care: local anesthesia + nitrous oxide and oxygen administration
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Usual care: local anesthesia + nitrous oxide and oxygen administration In this arm : sophrology is added
Intervention Type
Other
Intervention Name(s)
sophrology
Intervention Description
Sophrology session provided by a nurse sophrologist in addition to the usual care during BMAB
Primary Outcome Measure Information:
Title
Visual analog scale (VAS) score of the pain felt by the patient during the gesture of performing the BMAB
Description
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 Outcome Measure Information:
Title
Numerical score (NS) of anxiety of the patient before the BMAB
Description
The same scale is used to measure anxiety
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte Touchet
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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