Assessing Effectiveness of Acupuncture and Integrative Care in Reducing Anxiety and Pain in Patients Undergoing MOHS Surgery for Dermatological Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Anxiety as assessed by State-Trait Anxiety Inventory
研究概览
简要总结
MOHS method is an effective surgical technique to remove skin cancerous tumors in the head-neck area. Patients undergoing MOHS surgery are struggled with emotional stress during the day of surgery, due to fear of significant damage to the body's image and anxiety about the need for repeated surgeries. In this study we will examine the effect of integrative medicine (including acupuncture, touch/manual, and breathing/relaxation modalities) on the reduction of anxiety and pain in patients undergoing MOHS surgery.
详细描述
MOHS method is an effective surgical technique to remove skin cancerous tumors in the head-neck area, with immediate microscopic examination in a frozen slice of the full margin. Patients undergoing MOHS surgery are struggled with emotional stress during the day of surgery, due to fear of significant damage to the body's appearance and image and anxiety about the need for repeated surgeries performed on the same day to remove the tumor. In this study we will examine the effect of integrative medicine (including acupuncture, touch/manual, and breathing/relaxation modalities) on the reduction of anxiety and pain in patients undergoing MOHS surgery. The study was designed on the basis of interdisciplinary collaboration of researchers from plastic, integrative and gynecological medicine.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patients will be referred by the surgeon to MOHS surgery without knowing if integrative care will be provided at the surgery day. Allocation of integrative care to specific surgery days will be determined by a 1:1 randomization.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •* Patients referred to MOHS surgery
排除标准
- •Pregnancy
- •Hypertension treated with alpha and beta-blockers
- •Chronic atrial fibrillation
- •insulin dependent diabetes type 1
- •Thyroid disease (hyperthyroidism)
结局指标
主要结局
Anxiety as assessed by State-Trait Anxiety Inventory
时间窗: 8 hours
Alleviating anxiety throughout MOHS surgery
次要结局
- Heart rate variability (HRV)(30 minutes)
- Pain as assessed by visual analogue scale(60 minutes)
研究者
Eran Ben-Arye
Clinical associate professor
Carmel Medical Center