Auricular Acupressure for Reducing Perioperative Anxiety and Pain in Therapeutic Breast Surgery Following an Initial Breast Cancer Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Anxiety
研究概览
简要总结
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.
详细描述
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 Participation is voluntary and may be withdrawn at any time without consequences for the patient.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender
- •Breast cancer patients undergoing therapeutic breast surgery at Robert Bosch Hospital following an initial diagnosis.
- •Signed informed consent form.
排除标准
- •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.
研究组 & 干预措施
Auricular Acupressure NADA
The intervention group receives ear acupressure according to the NADA protocol.
干预措施: Auricular Acupressure NADA (Other)
Control group
The group receives standard preoperative care
结局指标
主要结局
Anxiety
时间窗: 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.
次要结局
- Anxiety(Immediately after the operation)
- Anxiety(One Day after the operation)
- Anxiety(Two Days after the operation)
- Anxiety(three days after the operation)
- Anxiety(four days after the operation)
- Anxiety(five days after the operation)
- Anxiety(six days after the operation)
- Anxiety(seven days after the operation)
- Anxiety(eight days after the operation)
- Anxiety(nine days after the operation)
- Anxiety(ten days after the operation)
- Pain intensity(Day 0, preoperative)
- Pain intensity(Immediately after the operation)
- Pain intensity(One Day after the operation)
- Pain intensity(Two days after the operation)
- Pain intensity(three days after the operation)
- Pain intensity(Four days after the operation)
- Pain intensity(five days after the operation)
- Pain intensity(six days after the operation)
- Pain intensity(seven days after the operation)
- Pain intensity(eight days after the operation)
- Pain intensity(nine days after the operation)
- Pain intensity(ten days after the operation)
- Nausea and vomiting(Ten Days after the operation)
- Nausea and vomiting(One Day after the operation)
- Nausea and vomiting(Two days after the operation)
- Nausea and vomiting(Three days after the operation)
- Nausea and vomiting(four days after the operation)
- Nausea and vomiting(Five days after the operation)
- Nausea and vomiting(Six days after the operation)
- Nausea and vomiting(Seven days after the operation)
- Nausea and vomiting(Eight days after the operation)
- Nausea and vomiting(Nine days after the operation)
- STAI-T(Before the operation)
- Preoperative Anxiety(Before the operation)
- Depression(Before the operation)
研究者
Marcela Winkler, MD
Head of Integrative Medicine
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)