Peri-operative Slow-paced Breathing - a Non-invasive Technique to Reduce Anxiety in Breast Cancer Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Peri operative anxiety
研究概览
简要总结
The purpose of this single-center trial is to examine the effects of a slow-breathing technique performed at induction of anesthesia in patients undergoing surgery for breast cancer on anxiety, scored by Spielberger's State-Trait Anxiety Inventory, state scale (STAI-S),13 compared to usual care.
详细描述
Rationale: In the perioperative period anxiety for anesthesia and the surgical procedure is common. Breast cancer surgery patients have a higher level of anxiety compared to other patients undergoing (cancer) surgery. Relaxation techniques, like breath focus with deep belly breathing are easy to learn and can have a beneficial effect on postoperative anxiety, pain, and postoperative nausea and vomiting (PONV), but the quality of evidence is low. Slow paced breathing at a frequency of 6 breaths per minute can possibly increase vagal activation, decrease anxiety, reduce mean blood pressure, and postoperative pain.
The investigators aim to apply a pre-trained slow paced breathing technique at induction of anesthesia for surgery, to reduce perioperative anxiety and to explore effects on pre-operative blood pressure, per-operative need of hypnotics, postoperative pain and opioid use, PONV and patient satisfaction.
Objective: This study aims to examine the effects of guided slow paced breathing performed at induction of anesthesia in patients undergoing surgery for breast cancer on anxiety, scored by Spielberger's State-Trait Anxiety Inventory, State scale (STAI-S), compared to usual care.
Study design: Single center, two-group, prospective, randomized controlled trial Study population: patients scheduled for surgery for breast cancer in the Antoni van Leeuwenhoek Hospital.
Intervention: Performance of pre-trained guided slow paced breathing by the patient at induction of anesthesia for breast surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergoing surgery for breast cancer in the Antoni van Leeuwenhoekziekenhuis
排除标准
- •Age < 18 years
- •History of severe pulmonary illness: severe asthma or severe chronic obstructive pulmonary disease (COPD) GOLD III or IV
- •Known or suspected severe psychiatric disorder
- •Unable to give written or oral informed consent
- •Patient refusal
- •Not able to understand Dutch
- •No internet access
- •Visual or hearing impairments interfering with reading and listening to the online material
结局指标
主要结局
Peri operative anxiety
时间窗: 2 weeks
The present study aims to examine the effects of pre-trained guided Slow PACE breathing performed at induction of anesthesia in patients undergoing surgery for breast cancer on anxiety, scored by Spielberger's State-Trait Anxiety Inventory, state scale (STAI-S), compared to usual care. The total score ranging from 20 to 80. Higher scores indicate higher levels of anxiety symptoms. A cut-off score of 40 is commonly used to define probable clinical levels of anxiety.
次要结局
- patient satisfaction(5 minutes on postoperative day 1)
- Anxiety trait scored by Spielberger's State Anxiety Inventory (STAI-T)13 at baseline(once at baseline, duration 10 minutes)
- need of hypnotics during induction(10 minutes)
- post-operative pain(post-operative on recovery (1-2hours))
- postoperative nausea and vomiting (PONV)(post-operative on recovery (1-2hours))
- mean blood pressure before induction(10 minutes)
- post-operative need of opioids(post-operative on recovery (1-2hours))
- Hospital Anxiety and Depression Scale (HADS-A)(once at baseline, duration 10 minutes)