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NCT Number: NCT07423039

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

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.

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Key information

Conditions

Breast Cancer Females Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Stuttgart, 70376, Germany

Location status: Recruiting

Location contact

Marcela Winkle, Dr. med.

CONTACT

[email protected]

071181012073

About this study

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 Participation is voluntary and may be withdrawn at any time without consequences for the patient.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Anxiety

    Time frame: Day 0, preoperative

    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.

Secondary outcomes

  1. Anxiety

    Time frame: Immediately after the operation

    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.

  2. Anxiety

    Time frame: One Day after the operation

    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.

  3. Anxiety

    Time frame: Two Days after the operation

    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.

  4. Anxiety

    Time frame: three days after the operation

    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.

  5. Anxiety

    Time frame: four days after the operation

    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.

  6. Anxiety

    Time frame: five days after the operation

    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.

  7. Anxiety

    Time frame: six days after the operation

    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.

  8. Anxiety

    Time frame: seven days after the operation

    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.

  9. Anxiety

    Time frame: eight days after the operation

    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.

  10. Anxiety

    Time frame: nine days after the operation

    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.

  11. Anxiety

    Time frame: ten days after the operation

    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.

  12. Pain intensity

    Time frame: Day 0, preoperative

    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.

  13. Pain intensity

    Time frame: Immediately after the operation

    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.

  14. Pain intensity

    Time frame: One Day after the operation

    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.

  15. Pain intensity

    Time frame: Two days after the operation

    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.

  16. Pain intensity

    Time frame: three days after the operation

    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.

  17. Pain intensity

    Time frame: Four days after the operation

    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.

  18. Pain intensity

    Time frame: five days after the operation

    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.

  19. Pain intensity

    Time frame: six days after the operation

    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.

  20. Pain intensity

    Time frame: seven days after the operation

    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.

  21. Pain intensity

    Time frame: eight days after the operation

    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.

  22. Pain intensity

    Time frame: nine days after the operation

    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.

  23. Pain intensity

    Time frame: ten days after the operation

    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.

  24. Nausea and vomiting

    Time frame: Ten Days after the operation

    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.

  25. Nausea and vomiting

    Time frame: One Day after the operation

    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.

  26. Nausea and vomiting

    Time frame: Two days after the operation

    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.

  27. Nausea and vomiting

    Time frame: Three days after the operation

    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.

  28. Nausea and vomiting

    Time frame: four days after the operation

    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.

  29. Nausea and vomiting

    Time frame: Five days after the operation

    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.

  30. Nausea and vomiting

    Time frame: Six days after the operation

    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.

  31. Nausea and vomiting

    Time frame: Seven days after the operation

    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.

  32. Nausea and vomiting

    Time frame: Eight days after the operation

    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.

  33. Nausea and vomiting

    Time frame: Nine days after the operation

    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.

  34. STAI-T

    Time frame: Before the operation

    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.

  35. Preoperative Anxiety

    Time frame: Before the operation

    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).

  36. Depression

    Time frame: Before the operation

    Beck Depression Inventory (BDI) Scores range between 0 and 63, with higher scores representing more severe depression symptoms.

Other outcomes

  1. Safety evaluation

    Time frame: Ten Days after the operation

    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.

  2. Infection

    Time frame: Ten days after the operation

    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.

  3. Postoperative bleeding

    Time frame: Ten days after the operation

    Cases of postoperative bleeding will be recorded as either 'yes' or 'no'. This information will be extracted from the patients' medical records.

Study contacts

Contact information is provided by the study sponsor or research team.

Marcela Winkler Dr. med.

CONTACT

[email protected]

+4915774281360

Marcela Winkler Dr. med. Marcela Winkler

CONTACT

[email protected]

+4915774281360

Sponsors and collaborators

Lead sponsor

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Other

Registry information

Official study title

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

Acronym: ROSA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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