About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female gender
Breast cancer patients undergoing therapeutic breast surgery at Robert Bosch Hospital following an initial diagnosis.
Signed informed consent form.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Auricular Acupressure NADA
Other intervention"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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
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.
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.
Postoperative bleeding
Cases of postoperative bleeding will be recorded as either 'yes' or 'no'. This information will be extracted from the patients' medical records.
Sponsors and contacts
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