NCT06056414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 8, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2025

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

September 21, 2023

Last Update Submit

December 29, 2025

Conditions

Breast Neoplasm

Keywords

macrobiopsyanxietyEnergy Resonance by Cutaneous Stimulation

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the reduction in ANXIETY STATE

    Evaluation of anxiety before and after RESC session using Spielberger scale

    1 day

Secondary Outcomes (2)

  • Evaluation of the reduction in ANXIETY STATE

    3 days

  • Evaluation of the reduction in ANXIETY STATE

    7 days

Study Arms (1)

Energy Resonance by Cutaneous Stimulation

EXPERIMENTAL

one Energy Resonance by Cutaneous Stimulation session performed before macrobiopsy

Other: Energy Resonance by Cutaneous Stimulation

Interventions

Energy Resonance by Cutaneous StimulationOTHER

Energy Resonance by Cutaneous Stimulation session

Energy Resonance by Cutaneous Stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, France

Location

MeSH Terms

Conditions

Breast NeoplasmsAnxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMental Disorders

Study Officials

  • Celine Lemaire

    Centre Henri Becquerel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2023

First Posted

September 28, 2023

Study Start

January 8, 2024

Primary Completion

July 2, 2025

Study Completion

July 9, 2025

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)