Auricular Acupressure for Perioperative Anxiety and Pain in Therapeutic Breast Surgery (ROSA)

NCT07423039 | Not Yet Recruiting DMC

• 1 other identifier: S00904-NIM
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized, controlled, single-center trial investigates the effects of auricular acupressure, administered according to the National Acupuncture Detoxification Association (NADA) protocol, on perioperative anxiety and pain in patients with a first diagnosis of breast cancer undergoing therapeutic breast surgery. Participants receiving auricular acupressure according to the NADA protocol will be compared with patients receiving standard care alone.

Conditions

Breast Cancer Females

Keywords

Anxiety; Pain; NADA Auricular Acupressure

Outcome Measures

Primary Outcomes (1)

• Anxiety

  The State-Trait Anxiety Inventory (STAI-S) is a 20-item scale used to measure anxiety levels, ranging from 20 to 80. Higher scores are positively correlated with higher anxiety levels.

  Day 0, preoperative

Secondary Outcomes (36)

• Anxiety

  Immediately after the operation

• Anxiety

  One Day after the operation

• Anxiety

  Two Days after the operation

• Anxiety

  three days after the operation

• Anxiety

  four days after the operation

Other Outcomes (3)

• Safety evaluation

  Ten Days after the operation

• Infection

  Ten days after the operation

• Postoperative bleeding

  Ten days after the operation

Study Arms (2)

Auricular Acupressure NADA

EXPERIMENTAL

The intervention group receives ear acupressure according to the NADA protocol.

Other: Auricular Acupressure NADA

Control group

NO INTERVENTION

The group receives standard preoperative care

Interventions

Auricular Acupressure NADA OTHER

"NADA" Auricular Acupressur: The intervention group receives ear acupressure according to the NADA protocol. Before surgery, patients receive Acupressure patches are placed on five specific points on the ear. These patches remain on the skin for five days. Patients are instructed to press or massage the beads in the patch three times a day.

Auricular Acupressure NADA

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female gender
• Breast cancer patients undergoing therapeutic breast surgery at Robert Bosch Hospital following an initial diagnosis.
• Signed informed consent form.

You may not qualify if:

• An anxiety disorder that has been diagnosed within the last 12 months.
• A mental state that, in the opinion of the investigator, prevents the patient from participating in the study.
• Use of hearing aids.
• Skin irritations or eczema in the ear.
• Pregnancy
• Insufficient knowledge of German
• Unwillingness to store and share personal medical data within the framework of the protocol
• Missing or incomplete declaration of consent
• Receipt of acupuncture treatment (including NADA ear acupuncture or acupressure) in the last three months.

Sponsors & Collaborators

• Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF): lead

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcela Winkler, Dr. med.

  Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

  STUDY DIRECTOR

Central Study Contacts

Marcela Winkler Dr. med. Marcela Winkler

CONTACT

+4915774281360; marcela.winkler@rbk.de

Marcela Winkler Dr. med.

CONTACT

+4915774281360; marcela.winkler@rbk.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Integrative Medicine

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02