Hematologic DiseasesBOM-ZENNCT04168983
Impact of Sophrology on the Pain Felt During a Bone Marrow Aspiration and Biopsy
A study testing sophrology in people with Hematologic Diseases and Diagnoses Disease, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Diseases, Diagnoses Disease, Pain
- What is being tested?
- sophrology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2019to 25 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- sophrology
- Medical subject headings
- Hematologic Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sophrologyOther
Sophrology session provided by a nurse sophrologist in addition to the usual care during BMAB
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: sophrology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Secondary outcomes (1)
Numerical score (NS) of anxiety of the patient before the BMAB
The same scale is used to measure anxiety
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start25 Sep 2019
- Primary completion25 Sep 2021
- Study completion25 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single centre, comparative, controlled randomized study
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte Touchet, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168983
- Sponsor's protocol ID
- 2019-A00796-51
- Acronym
- BOM-ZEN
- Status last verified
- Feb 2022
- First submitted
- 3 Oct 2019
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Sophrology on the Pain Felt During a Bone Marrow Aspiration and Biopsy
- ClinicalTrials.gov ID
- NCT04168983
- Acronym / sponsor ID
- BOM-ZEN / 2019-A00796-51
- Conditions
- Hematologic Diseases, Diagnoses Disease, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 25 Sep 2021 (actual)
- Study completion
- 25 Sep 2021 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single centre, comparative, controlled randomized study
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care: local anesthesia + nitrous oxide and oxygen administration |
| Experimental | Experimental | Other: sophrologyUsual care: local anesthesia + nitrous oxide and oxygen administration In this arm : sophrology is added |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sophrologySophrology session provided by a nurse sophrologist in addition to the usual care during BMAB | Other | Experimental |
Primary outcome
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)
1 secondary outcome
Numerical score (NS) of anxiety of the patient before the BMAB
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Touchet principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sophrology in people with Hematologic Diseases and Diagnoses Disease, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) score of the pain felt by the patient during the gesture of performing the BMAB (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.