NCT Number: NCT07423039
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.
Trial opening soon.
Get Notified18 year–99 year
Female
Interventional
Not applicable
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 Participation is voluntary and may be withdrawn at any time without consequences for the patient.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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
"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.
Time frame: 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.
Time frame: 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.
Time frame: One Day 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.
Time frame: Two Days 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.
Time frame: three days 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.
Time frame: four days 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.
Time frame: five days 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.
Time frame: six days 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.
Time frame: seven days 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.
Time frame: eight days 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.
Time frame: nine days 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.
Time frame: ten days after the operation
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: 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.
Time frame: Immediately after the operation
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 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 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 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 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 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 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 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 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 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
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
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
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
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
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
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
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
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
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
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
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: 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.
Time frame: 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).
Time frame: Before the operation
Beck Depression Inventory (BDI) Scores range between 0 and 63, with higher scores representing more severe depression symptoms.
Time frame: Ten Days after the operation
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
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
Cases of postoperative bleeding will be recorded as either 'yes' or 'no'. This information will be extracted from the patients' medical records.
Contact information is provided by the study sponsor or research team.
Marcela Winkler Dr. med.
CONTACT
Marcela Winkler Dr. med. Marcela Winkler
CONTACT
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Other
Auricular Acupressure for Reducing Perioperative Anxiety and Pain in Therapeutic Breast Surgery Following an Initial Breast Cancer Diagnosis
Acronym: ROSA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07553702
Breast - Female, Breast Cancer
São Luís, Maranhão, Brazil
View Trial DetailsNCT07547423
Breast Cancer Females, Breast Diseases
Taichung, Taiwan
View Trial DetailsNCT07434817
Breast Cancer Females, Newly Diagnosed Breast Cancer
Aurora, Colorado, United States
View Trial DetailsNCT07407517
Breast Cancer Females, Breast Diseases
View Trial Details