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

Auricular Acupressure for Reducing Perioperative Anxiety and Pain in Therapeutic Breast Surgery Following an Initial Breast Cancer Diagnosis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Females
• Intervention / Treatment: Other: Auricular Acupressure NADA

Detailed Description

Participant recruitment is conducted directly through the clinical department Naturopathy and integrative medicine in the Rober-Bosch-Hospital . During routine care, the study physician informs eligible patients about the study and provides the patient information sheet upon initial interest. The physician subsequently conducts a comprehensive informed-consent discussion and addresses all patient questions. Written consent is obtained only after this process. Participation is voluntary and may be withdrawn at any time without consequences for the patient.

Patients will complete validated instruments measuring anxiety and pain. Participants randomized to the intervention group (auriculotherapy) will receive the treatment during their hospitalization and will be compared with a control group receiving standard care.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcela Winkler Dr. med. Marcela Winkler; Phone Number: +4915774281360; Email: marcela.winkler@rbk.de
• Study Contact Backup: Name: Marcela Winkler Dr. med.; Phone Number: +4915774281360; Email: marcela.winkler@rbk.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Auricular Acupressure NADA; The intervention group receives ear acupressure according to the NADA protocol.	Other: Auricular Acupressure NADA; "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.
No Intervention: Control group; The group receives standard preoperative care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after the operation
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.	One Day after the operation
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.	Two Days after the operation
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.	three days after the operation
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.	four days after the operation
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.	five days after the operation
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.	six days after the operation
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.	seven days after the operation
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.	eight days after the operation
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.	nine days after the operation
Anxiety	The State-Trait Anxiety Inventory (STAI-S) is a 40-item scale used to measure anxiety levels, ranging from 20 to 80. Higher scores are positively correlated with higher anxiety levels.	ten days after the operation
Pain intensity	Pain intensity is recorded using a numerical rating scale from 0 to 10, where 0 is no pain and 10 is severe pain and and the medication the patient is taking, as recorded in the patient file.	Day 0, preoperative
Pain intensity	Pain intensity is recorded using a numerical rating scale from 0 to 10, where 0 is no pain and 10 is severe pain and and the medication the patient is taking, as recorded in the patient file.	Immediately after the operation
Pain intensity	Pain intensity is recorded using a numerical rating scale from 0 to 10, where 0 is no pain and 10 is severe pain and and the medication the patient is taking, as recorded in the patient file.	One Day after the operation
Pain intensity	Pain intensity is recorded using a numerical rating scale from 0 to 10, where 0 is no pain and 10 is severe pain and and the medication the patient is taking, as recorded in the patient file.	Two days after the operation
Pain intensity	Pain intensity is recorded using a numerical rating scale from 0 to 10, where 0 is no pain and 10 is severe pain and and the medication the patient is taking, as recorded in the patient file.	three days after the operation
Pain intensity	Pain intensity is recorded using a numerical rating scale from 0 to 10, where 0 is no pain and 10 is severe pain and and the medication the patient is taking, as recorded in the patient file.	Four days after the operation
Pain intensity	Pain intensity is recorded using a numerical rating scale from 0 to 10, where 0 is no pain and 10 is severe pain and and the medication the patient is taking, as recorded in the patient file.	five days after the operation
Pain intensity	Pain intensity is recorded using a numerical rating scale from 0 to 10, where 0 is no pain and 10 is severe pain and and the medication the patient is taking, as recorded in the patient file.	six days after the operation
Pain intensity	Pain intensity is recorded using a numerical rating scale from 0 to 10, where 0 is no pain and 10 is severe pain and and the medication the patient is taking, as recorded in the patient file.	seven days after the operation
Pain intensity	Pain intensity is recorded using a numerical rating scale from 0 to 10, where 0 is no pain and 10 is severe pain and and the medication the patient is taking, as recorded in the patient file.	eight days after the operation
Pain intensity	Pain intensity is recorded using a numerical rating scale from 0 to 10, where 0 is no pain and 10 is severe pain and and the medication the patient is taking, as recorded in the patient file.	nine days after the operation
Pain intensity	Pain intensity is recorded using a numerical rating scale from 0 to 10, where 0 is no pain and 10 is severe pain and and the medication the patient is taking, as recorded in the patient file.	ten days after the operation
Nausea and vomiting	PONV stands for postoperative nausea and vomiting, which describes nausea and vomiting after surgery. It is documented on a scale from 0 to 10, where 0 is no nausea and 10 is the most severe nausea imaginable. The use of antiemetics will be registered in the patient file.	Ten Days after the operation
Nausea and vomiting	PONV stands for postoperative nausea and vomiting, which describes nausea and vomiting after surgery. It is documented on a scale from 0 to 10, where 0 is no nausea and 10 is the most severe nausea imaginable. The use of antiemetics will be registered in the patient file.	One Day after the operation
Nausea and vomiting	PONV stands for postoperative nausea and vomiting, which describes nausea and vomiting after surgery. It is documented on a scale from 0 to 10, where 0 is no nausea and 10 is the most severe nausea imaginable. The use of antiemetics will be registered in the patient file.	Two days after the operation
Nausea and vomiting	PONV stands for postoperative nausea and vomiting, which describes nausea and vomiting after surgery. It is documented on a scale from 0 to 10, where 0 is no nausea and 10 is the most severe nausea imaginable. The use of antiemetics will be registered in the patient file.	Three days after the operation
Nausea and vomiting	PONV stands for postoperative nausea and vomiting, which describes nausea and vomiting after surgery. It is documented on a scale from 0 to 10, where 0 is no nausea and 10 is the most severe nausea imaginable. The use of antiemetics will be registered in the patient file.	four days after the operation
Nausea and vomiting	PONV stands for postoperative nausea and vomiting, which describes nausea and vomiting after surgery. It is documented on a scale from 0 to 10, where 0 is no nausea and 10 is the most severe nausea imaginable. The use of antiemetics will be registered in the patient file.	Five days after the operation
Nausea and vomiting	PONV stands for postoperative nausea and vomiting, which describes nausea and vomiting after surgery. It is documented on a scale from 0 to 10, where 0 is no nausea and 10 is the most severe nausea imaginable. The use of antiemetics will be registered in the patient file.	Six days after the operation
Nausea and vomiting	PONV stands for postoperative nausea and vomiting, which describes nausea and vomiting after surgery. It is documented on a scale from 0 to 10, where 0 is no nausea and 10 is the most severe nausea imaginable. The use of antiemetics will be registered in the patient file.	Seven days after the operation
Nausea and vomiting	PONV stands for postoperative nausea and vomiting, which describes nausea and vomiting after surgery. It is documented on a scale from 0 to 10, where 0 is no nausea and 10 is the most severe nausea imaginable. The use of antiemetics will be registered in the patient file.	Eight days after the operation
Nausea and vomiting	PONV stands for postoperative nausea and vomiting, which describes nausea and vomiting after surgery. It is documented on a scale from 0 to 10, where 0 is no nausea and 10 is the most severe nausea imaginable. The use of antiemetics will be registered in the patient file.	Nine days after the operation
STAI-T	STAI-T scale is a standardised method of measuring anxiety. This refers to the measurement of trait anxiety. The range of possible scores varies from a minimum of 20 to a maximum of 80, where higher scores represent higher anxiety.	Before the operation
Preoperative Anxiety	The APAIS (Amsterdam Preoperative Anxiety and Information Scale) is a questionnaire designed to assess preoperative anxiety and patients' need for information. The questionnaire consists of six questions, divided into two scales: four questions about anxiety related to anesthesia and surgery, and two questions about the need for information. Six questions were answered using a five-point Likert scale ranging from 1 (not anxious at all) to 5 (extremely anxious).	Before the operation
Depression	Beck Depression Inventory (BDI) Scores range between 0 and 63, with higher scores representing more severe depression symptoms.	Before the operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation	To assess safety, participants will be asked whether they experienced any adverse events (AEs) during the intervention period. All reported AEs will be documented and classified by type and severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The outcome will be the number of participants with at least one treatment-related adverse event recorded from baseline throgh the end of the intervention.	Ten Days after the operation
Infection	Cases of infection in the surgical area requiring antibiotic treatment will be recorded as either "Yes" or "No". This data will be extracted from the patient's medical records.	Ten days after the operation
Postoperative bleeding	Cases of postoperative bleeding will be recorded as either 'yes' or 'no'. This information will be extracted from the patients' medical records.	Ten days after the operation

Collaborators and Investigators

• Sponsor: Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
• Investigators: Study Director: Marcela Winkler, Dr. med., Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Anxiety; NADA Auricular Acupressure
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders
• Other Study ID Numbers: S00904-NIM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No