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

Официальное название

Auricular Acupressure for Reducing Perioperative Anxiety and Pain in Therapeutic Breast Surgery Following an Initial Breast Cancer Diagnosis

Обзор

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.

Подробное описание

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 Participation is voluntary and may be withdrawn at any time without consequences for the patient.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.

Вмешательства

• Другое Auricular 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.

Первичные конечные точки

• Anxiety [Срок оценки: Day 0, preoperative]

Вторичные конечные точки (12)

• Anxiety [Срок оценки: Immediately after the operation]
• Anxiety [Срок оценки: One Day after the operation]
• Anxiety [Срок оценки: Two Days after the operation]
• Anxiety [Срок оценки: three days after the operation]
• Anxiety [Срок оценки: four days after the operation]
• Anxiety [Срок оценки: five days after the operation]
• Anxiety [Срок оценки: six days after the operation]
• Anxiety [Срок оценки: seven days after the operation]
• Anxiety [Срок оценки: eight days after the operation]
• Anxiety [Срок оценки: nine days after the operation]
• Anxiety [Срок оценки: ten days after the operation]
• Pain intensity [Срок оценки: Day 0, preoperative]

Критерии участия

Критерии включения

• Female gender
• Breast cancer patients undergoing therapeutic breast surgery at Robert Bosch Hospital following an initial diagnosis.
• Signed informed consent form.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07423039 · S00904-NIM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗