Biobehavioral Effects of Hypnosis During Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Hypnosedation (HS) feasibility
研究概览
简要总结
This clinical trial studies how well hypnosedation works in relaxing and reducing the need for general anesthesia in patients who are undergoing breast cancer surgery. Hypnosedation is a technique that places patients under conscious sedation where they remain awake and numbed during surgery and involves the use of words and images to help patients relax and to affect their thoughts about what is happening during surgery.
详细描述
PRIMARY OBJECTIVES:
I. Determine the feasibility of conducting a randomized controlled trial (RCT) of hypnosedation (HS) during breast cancer surgery.
SECONDARY OBJECTIVES:
I. Assess the preliminary efficacy of HS with local anesthesia versus (vs) opioid based general anesthesia (GA) on reducing self-reported anxiety, pain, nausea, vomiting, cancer-related symptoms, and surgical complication rates.
II. Preliminarily evaluate changes in immune markers (natural killer cell function, cytokines, and resolution of inflammatory response markers) and endocrine function (epinephrine, norepinephrine, and cortisol).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Female clinical stage 0/1 breast cancers patients scheduled to undergo a unilateral, segmental mastectomy +/- sentinel lymph node dissection
- •Able to read, speak, and write English or Spanish
排除标准
- •A significant anxiety disorder
- •Significant pain during core biopsy as reported by the patient
- •Received neoadjuvant chemotherapy, any autoimmune or immunological disease or taking any immune suppression drugs
- •Plastic surgery involvement for oncoplastic reconstruction
- •If surgery is likely greater than 3 hours
研究组 & 干预措施
Group I (hypnosedation)
Patients undergo hypnosedation performed by a mind-body specialist before surgery begins and continuing until after surgery is complete.
干预措施: Hypnosedation (Behavioral)
Group I (hypnosedation)
Patients undergo hypnosedation performed by a mind-body specialist before surgery begins and continuing until after surgery is complete.
干预措施: Questionnaire Administration (Other)
Group II (verbal support)
Patients speak to a mind-body specialist before surgery and prior to receiving general anesthesia.
干预措施: Questionnaire Administration (Other)
Group II (verbal support)
Patients speak to a mind-body specialist before surgery and prior to receiving general anesthesia.
干预措施: Verbal Support (Behavioral)
结局指标
主要结局
Hypnosedation (HS) feasibility
时间窗: Up to 1 day
Will be determined by two criteria: overall accrual and successful delivery of HS. The intervention will be deemed feasible if: 1) \>= 30% of enrolled patients consent and \>= 60% of enrolled patients in HS complete surgery without the need of general anesthesia. The study will calculate rates, frequencies, and 90% confidence intervals (CIs), as applicable.
次要结局
- Changes in EEG activity as assessed using standardized low-resolution brain electromagnetic tomography (sLORETA)(Baseline up to 14 days post-surgery)
- Group differences in medical costs(From the date of surgery up to 14 days)
- Assessment of changes in immune markers and endocrine function(Up to 14 days post-surgery)
- Efficacy of HS(Up to 1 day)