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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 Participation is voluntary and may be withdrawn at any time without consequences for the patient.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auricular Acupressure NADA | Experimental | The intervention group receives ear acupressure according to the NADA protocol. |
|
| Control group | No Intervention | The group receives standard preoperative care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0, preoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after the operation |
| Anxiety |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcela Winkler Dr. med. Marcela Winkler | Contact | +4915774281360 | marcela.winkler@rbk.de | |
| Marcela Winkler Dr. med. | Contact | +4915774281360 | marcela.winkler@rbk.de |
| Name | Affiliation | Role |
|---|---|---|
| Marcela Winkler, Dr. med. | Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) | Study Director |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | Before the operation |
| Depression | Beck Depression Inventory (BDI) Scores range between 0 and 63, with higher scores representing more severe depression symptoms. | Before the operation |
| Ten Days after the operation |
| 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. | Ten days after the operation |
| Postoperative bleeding | Cases of postoperative bleeding will be recorded as either 'yes' or 'no'. This information will be extracted from the patients' medical records. | Ten days after the operation |