Breast Cancer FemalesROSANCT07423039
Auricular Acupressure for Perioperative Anxiety and Pain in Therapeutic Breast Surgery (ROSA)
A study testing Auricular Acupressure NADA in people with Breast Cancer Females, run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer Females
- What is being tested?
- Auricular Acupressure NADA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- 31 Mar 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female gender
- Breast cancer patients undergoing therapeutic breast surgery at Robert Bosch Hospital following an initial diagnosis.
- Signed informed consent form.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Stuttgart, 70376
Marcela Winkle, Dr. med., 071181012073, marcela.winkler@rbk.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer Females
- Being tested
- Auricular Acupressure NADA
- Keywords
- Anxiety, Pain, NADA Auricular Acupressure
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Acupressure NADAOther
"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.
| Study group | Role | What they receive |
|---|---|---|
| Auricular Acupressure NADA | Experimental | The intervention group receives ear acupressure according to the NADA protocol. Receives: Other: Auricular Acupressure NADA |
| Control group | No intervention | The group receives standard preoperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0, preoperative
Secondary outcomes (36)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Before the operation
Depression
Beck Depression Inventory (BDI) Scores range between 0 and 63, with higher scores representing more severe depression symptoms.
Measured: Before the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start31 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcela Winkler, MD, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Investigators
- Marcela Winkler, Dr. med., Study director, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423039
- Sponsor's protocol ID
- S00904-NIM
- Acronym
- ROSA
- Status last verified
- Aug 2026
- First submitted
- 20 Jan 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bilc M, Beiner E, Triana J, Rubio Rodriguez I, Birmanac-Pfluger A, Cramer H, Winkler M. Auricular Acupressure for Perioperative Anxiety and Pain in Therapeutic Breast Surgery: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2026 Aug 21;15:e97469. doi: 10.2196/97469.
PubMed 42627947