Breast Cancer Females
Conditions
Keywords
Anxiety, Pain, NADA Auricular Acupressure
Brief summary
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 Participation is voluntary and may be withdrawn at any time without consequences for the patient.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
OTHERAuricular 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.
Sponsors
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | Day 0, preoperative | 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
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | Immediately after the operation | 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. |
| Pain intensity | Day 0, preoperative | 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. |
| Nausea and vomiting | Ten Days after the operation | 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. |
| STAI-T | Before the operation | 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. |
| Preoperative Anxiety | Before the operation | 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). |
| Depression | Before the operation | Beck Depression Inventory (BDI) Scores range between 0 and 63, with higher scores representing more severe depression symptoms. |
Countries
Germany
Contacts
CONTACTMarcela Winkler Dr. med. Marcela Winkler
CONTACTMarcela Winkler Dr. med.
STUDY_DIRECTORMarcela Winkler, Dr. med.
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Outcome results
None listed