- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06056414
Study of Anxiety After a Session of Energy Resonance by Cutaneous Stimulation (MBRESC)
Study of the Reduction of Anxiety After a Session of Energy Resonance by Cutaneous Stimulation in the Management of Patients Requiring Breast Macrobiopsy.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rouen, France
- Centre Henri Becquerel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Energy Resonance by Cutaneous Stimulation
one Energy Resonance by Cutaneous Stimulation session performed before macrobiopsy
|
Energy Resonance by Cutaneous Stimulation session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of the reduction in ANXIETY STATE
Time Frame: 1 day
|
Evaluation of anxiety before and after RESC session using Spielberger scale
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of the reduction in ANXIETY STATE
Time Frame: 3 days
|
Evaluation of anxiety before and after RESC session using Spielberger scale
|
3 days
|
|
Evaluation of the reduction in ANXIETY STATE
Time Frame: 7 days
|
Evaluation of anxiety before and after RESC session using Spielberger scale
|
7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Celine Lemaire, Centre Henri Becquerel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHB23.02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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