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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06056414
Other study ID # CHB23.02
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2, 2023
Est. completion date October 9, 2023

Study information

Verified date September 2023
Source Centre Henri Becquerel
Contact Celine Lemaire
Phone +33232082985
Email celine.lemaire@chb.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Performing a breast macrobiopsy can be extremely delicate and anxiety-provoking. It can have an impact on the course of future examinations. Patients' emotional feelings also have a definite impact on the nursing staff. The purpose of the MBRESC study is to evaluate Energy Resonance by Cutaneous Stimulation , a manual acupressure technique, in the management of anxiety prior to breast macrobiopsy.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 57
Est. completion date October 9, 2023
Est. primary completion date October 9, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient has received full information on the organization and purpose of the research, and has signed an informed consent form. - Patient over 18 years of age - Patient undergoing a diagnostic breast macrobiopsy for suspected breast cancer - Patient undergoing a macro breast biopsy for the first time - Patient affiliated to or benefiting from a social security schem Exclusion Criteria: - Patient with a history of breast cancer or other pathologies requiring invasive procedures - Patient with several lesions to be biopsied - Patient with psychiatric pathology - Patient under anxiolytic or psychotropic treatment initiated in the month before the breast macrobiopsy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Energy Resonance by Cutaneous Stimulation
Energy Resonance by Cutaneous Stimulation session

Locations

Country Name City State
France Centre Henri Becquerel Rouen

Sponsors (1)

Lead Sponsor Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of the reduction in ANXIETY STATE Evaluation of anxiety before and after RESC session using Spielberger scale 1 day
Secondary Evaluation of the reduction in ANXIETY STATE Evaluation of anxiety before and after RESC session using Spielberger scale 3 days
Secondary Evaluation of the reduction in ANXIETY STATE Evaluation of anxiety before and after RESC session using Spielberger scale 7 days
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