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.
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 Participation is voluntary and may be withdrawn at any time without consequences for the patient.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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
66
"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.
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Stuttgart, Germany
RECRUITINGAnxiety
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
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
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
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
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
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: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Before the operation
Depression
Beck Depression Inventory (BDI) Scores range between 0 and 63, with higher scores representing more severe depression symptoms.
Time frame: Before the operation
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