Back to resultsStudy of Anxiety After a Session of Energy Resonance by Cutaneous Stimulation (MBRESC)
Primary Purpose
Breast Neoplasm
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Energy Resonance by Cutaneous Stimulation
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Neoplasm focused on measuring macrobiopsy, anxiety, Energy Resonance by Cutaneous Stimulation
Eligibility Criteria
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
Sites / Locations
- Centre Henri Becquerel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Energy Resonance by Cutaneous Stimulation
Arm Description
one Energy Resonance by Cutaneous Stimulation session performed before macrobiopsy
Outcomes
Primary Outcome Measures
Evaluation of the reduction in ANXIETY STATE
Evaluation of anxiety before and after RESC session using Spielberger scale
Secondary Outcome Measures
Evaluation of the reduction in ANXIETY STATE
Evaluation of anxiety before and after RESC session using Spielberger scale
Evaluation of the reduction in ANXIETY STATE
Evaluation of anxiety before and after RESC session using Spielberger scale
Full Information
NCT ID
NCT06056414
First Posted
September 21, 2023
Last Updated
October 9, 2023
Sponsor
Centre Henri Becquerel
1. Study Identification
Unique Protocol Identification Number
NCT06056414
Brief Title
Study of Anxiety After a Session of Energy Resonance by Cutaneous Stimulation
Acronym
MBRESC
Official Title
Study of the Reduction of Anxiety After a Session of Energy Resonance by Cutaneous Stimulation in the Management of Patients Requiring Breast Macrobiopsy.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2, 2023 (Anticipated)
Primary Completion Date
October 9, 2023 (Anticipated)
Study Completion Date
October 9, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm
Keywords
macrobiopsy, anxiety, Energy Resonance by Cutaneous Stimulation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Energy Resonance by Cutaneous Stimulation
Arm Type
Experimental
Arm Description
one Energy Resonance by Cutaneous Stimulation session performed before macrobiopsy
Intervention Type
Other
Intervention Name(s)
Energy Resonance by Cutaneous Stimulation
Intervention Description
Energy Resonance by Cutaneous Stimulation session
Primary Outcome Measure Information:
Title
Evaluation of the reduction in ANXIETY STATE
Description
Evaluation of anxiety before and after RESC session using Spielberger scale
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Evaluation of the reduction in ANXIETY STATE
Description
Evaluation of anxiety before and after RESC session using Spielberger scale
Time Frame
3 days
Title
Evaluation of the reduction in ANXIETY STATE
Description
Evaluation of anxiety before and after RESC session using Spielberger scale
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Celine Lemaire
Phone
+33232082985
Email
celine.lemaire@chb.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Doriane Richard
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celine Lemaire
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline Lemaire
Phone
+33232082985
Email
celine.lemaire@chb.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Doriane Richard
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Anxiety After a Session of Energy Resonance by Cutaneous Stimulation
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