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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorRobert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

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 volunteers

Qualifiers

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

Design model

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

66 Participants
are divided into 2 treatment groups
Group A: Auricular Acupressure NADAExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 0, preoperative

Secondary outcomes

1

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.

Time frame
Immediately after the operation
2

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.

Time frame
One Day after the operation
3

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.

Time frame
Two Days after the operation
4

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.

Time frame
three days after the operation

Other outcomes

1

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.

Time frame
Ten Days after the operation
2

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.

Time frame
Ten days after the operation
3

Postoperative bleeding

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

Time frame
Ten days after the operation

Sponsors and contacts

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