Study of Anxiety After a Session of Energy Resonance by Cutaneous Stimulation

Breast Neoplasm Clinical Trial

— 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06056414
• Other study ID #: CHB23.02
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

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