Study of Anxiety After a Session of Energy Resonance by Cutaneous Stimulation (MBRESC)

October 9, 2023 updated by: Centre Henri Becquerel

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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: Energy Resonance by Cutaneous Stimulation
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

This is where you will find people and organizations involved with this study.

Sponsor

Centre Henri Becquerel

Investigators

  • Principal Investigator: Celine Lemaire, Centre Henri Becquerel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 2, 2023

Primary Completion (Estimated)

October 9, 2023

Study Completion (Estimated)

October 9, 2023

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Estimated)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHB23.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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