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

• Sponsor: Centre Henri Becquerel (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06056414
• Collaborator: (none)
• Enrollment: 57
• Location: 1
• Arm: 1
• Anticipated Duration (Days): 7
• Patients Per Site Per Month: 247.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm	Other: Energy Resonance by Cutaneous Stimulation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 57 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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.
• Anticipated Study Start Date: Oct 2, 2023
• Anticipated Primary Completion Date: Oct 9, 2023
• Anticipated Study Completion Date: Oct 9, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Evaluation of the reduction in ANXIETY STATE [1 day]

   Evaluation of anxiety before and after RESC session using Spielberger scale

Secondary Outcome Measures

1. Evaluation of the reduction in ANXIETY STATE [3 days]

   Evaluation of anxiety before and after RESC session using Spielberger scale

2. Evaluation of the reduction in ANXIETY STATE [7 days]

   Evaluation of anxiety before and after RESC session using Spielberger scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Henri Becquerel	Rouen		France

Sponsors and Collaborators

• Centre Henri Becquerel

Investigators

• Principal Investigator: Celine Lemaire, Centre Henri Becquerel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Henri Becquerel
• ClinicalTrials.gov Identifier: NCT06056414
• Other Study ID Numbers: CHB23.03
• First Posted: Sep 28, 2023
• Last Update Posted: Sep 28, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Henri Becquerel: macrobiopsy; anxiety; Energy Resonance by Cutaneous Stimulation
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Sep 28, 2023