A Pilot Study of the Utility of Auricular Acupressure in Enhancing Prehabilitation Benefits in Candidates for Thoracic Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of patients enrolled
研究概览
简要总结
Complementary medicine is recognized for its ability to enhance appetite, increase energy, reduce anxiety, decrease pain, and improve sleep, among many other benefits. Acupuncture is among the most frequent types of complementary medicine practiced in the US, and Medicare currently includes back pain as a reimbursable indication for this therapy. Acupuncture-related therapies may enhance efforts at prehabilitation in candidates for major lung resection.
详细描述
The plan is to use a small number of points for auricular acupressure that are selected to improve overall health, both physical and mental. Auricular acupuncture for management of pain using 5 points, informally referred to as "battlefield acupuncture" has demonstrated significant improvement in acute and chronic pain management. Auricular acupressure using a similarly small number of points has demonstrated improvement in chemotherapy-related disturbed sleep, fatigue, and appetite, postpartum depression and fatigue, and chemotherapy related fatigue and depression. It appears that auricular acupressure may be suitable for enhancing prehabilitation interventions for preoperative patients.
Patients will be selected from among individuals being considered for major lung surgery (wedge resection, segmentectomy, lobectomy, bilobectomy, or pneumonectomy; open or minimally invasive) who are expected to pursue a period of prehabilitation of 2 or more weeks prior to surgery.
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
- Single (Participant)
盲法说明
A random number card will be drawn in sequence from a box. Even numbered cards will assign the patient to the experimental group, odd numbered cards will assign the patient to the control group. For the sham intervention (Sham Type II, same intervention with seeding and intermittent pressing) the seeds are placed at nonacupressure points for the control group.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being considered for major lung surgery
- •Surgery is not scheduled for at least 2 weeks
- •Age ≥ 50 years
- •Able to understand English at a 4th grade level
- •No known contraindications to prehabilitation (strength, endurance, balance exercises)
- •Able to provide informed consent for participation
- •Has an adult care partner who will be available and capable of placing seeds
- •Has access to smart phone for communication and image sharing
- •Underwent frailty screening (given any score)
- •Able to perform spirometry testing in clinic
排除标准
- •Allergy to Vaccaria seeds
- •Medical condition affecting either ear preventing use of auricular acupressure such as eczema, frostbite, sunburn
研究组 & 干预措施
Experimental Group
A random number card will be drawn in sequence from a box. Even numbered cards will assign the patient to the experimental group, odd numbered cards will assign the patient to the control group.
o Intervention group seed points:
- Shen Men (anxiety, depression, stress, pain)
- Point 0 (homeostasis, energy, mood)
- Endocrine (hormonal homeostasis)
- Subcortex (insomnia, anxiety, pain, inflammation)
- Autonomic (autonomic balance, pain)
干预措施: Auricular Acupressure (Other)
Control Group
A random number card will be drawn in sequence from a box. Even numbered cards will assign the patient to the experimental group, odd numbered cards will assign the patient to the control group.
o Control group sham seed points:
- Inside edge, center of tragus
- Helix midway between apex and tubercle
- Helix 1 cm anterior to apex
- 5 mm anterior to Shen Men
- Covered, 5 mm anterior and superior to endocrine
For the sham intervention (Sham Type II, same intervention with seeding and intermittent pressing) the seeds are placed at nonacupressure points for the control group.
干预措施: Auricular Acupressure (Other)
结局指标
主要结局
Number of patients enrolled
时间窗: 2 weeks
The patient will complete a form after each seed pressing confirming the pressing and the time.
次要结局
- Ease of participation in the study.(End of Study (Week 4))