Auricular Acupressure for Perioperative Anxiety and Pain in Therapeutic Breast Surgery (ROSA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Auricular Acupressure NADA.
- Who it may be relevant to
- Registry conditions: Breast Cancer Females. Basic parameters: 18 years — 99 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Auricular Acupressure for Reducing Perioperative Anxiety and Pain in Therapeutic Breast Surgery Following an Initial Breast Cancer Diagnosis
Overview
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.
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 Participation is voluntary and may be withdrawn at any time without consequences for the patient.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.
Interventions
- 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.
Primary outcome measures
- Anxiety [Time frame: Day 0, preoperative]
Secondary outcome measures (12)
- Anxiety [Time frame: Immediately after the operation]
- Anxiety [Time frame: One Day after the operation]
- Anxiety [Time frame: Two Days after the operation]
- Anxiety [Time frame: three days after the operation]
- Anxiety [Time frame: four days after the operation]
- Anxiety [Time frame: five days after the operation]
- Anxiety [Time frame: six days after the operation]
- Anxiety [Time frame: seven days after the operation]
- Anxiety [Time frame: eight days after the operation]
- Anxiety [Time frame: nine days after the operation]
- Anxiety [Time frame: ten days after the operation]
- Pain intensity [Time frame: Day 0, preoperative]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07423039 · S00904-NIM