The Effect on Back Pain and Fatigue Level of Acupressure After Coronary Angiography: A Randomized, Single-Blind Sham-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Visual Analog Scale for Pain
研究概览
简要总结
This research was conducted with the aim of determining the effect of acupressure on the level of back pain and fatigue after coronary angiography.
详细描述
To prevent bleeding, hematoma, and embolism after coronary angiography, patients are asked to stay in bed for 6 to 24 hours. During complete bed rest for at least 6 hours, the patient should keep his/her feet flat. The patient should lie in the supine position and avoid rapid movements. Long-term bed rest (at least 6 hours) in post-angiographic patients causes weakening of the lower back muscles and fatigue due to the pressure constantly applied to the same muscles, while muscle fatigue causes muscle spasms and lower back pain. Today, acupressure is also used along with various pharmacological treatments to relieve pain and fatigue.
Acupressure is a massage technique that ensures the proper functioning of energy channels by applying some pressure to certain parts of the body with the thumbs or index fingers, hands, palms, wrists and knees for therapeutic purposes. Acupressure points are the same as acupuncture points. Although there is no needle inserted into the body as in acupuncture.
According to G-power analysis, the total number of samples was calculated as 120.
A total of 120 participants will be randomly assigned to the acupuncture group (n=40), sham acupuncture group (n=40) and control group (n=40).
A Personal Information Form and Visual Analog Scales for Pain and Fatigue will be used to collect data.
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
Patients in the acupressure and sham acupressure groups were blinded as to which groups they were in.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned coronary angiography from the femoral region
- •Not diagnosed with low back pain
- •No stent or other interventional procedure was performed during the coronary angiography procedure.
排除标准
- •Those who have had acupressure before for any purpose
- •Problems such as bleeding and dysrhythmia occur after coronary angiography,
- •Those with burns, scars, scratches and deformities at the acupressure point
- •Having any psychological disorder,
研究组 & 干预措施
Acupressure group
After coronary angiography, acupressure will be applied for a total of 15 minutes. For the acupressure group, a total of three points will be applied: the heart meridian 7th point (HT7), the large intestine meridian 4th point (LI4), and the stomach meridian 36th point (ST36), which is deemed appropriate in the lower extremity.
The symmetry of the three selected different points will also be applied to the other extremity.
干预措施: Acupressure (Other)
Sham acupressure
In the acupressure application applied to the sham group, parallel pressure will be applied to the bone area and points where the HT7, LI4, ST36 meridians do not pass.
干预措施: Sham acupressure (Other)
Control group
With the control group, no intervention was conducted, and only standard care was given.
结局指标
主要结局
Visual Analog Scale for Pain
时间窗: 1 year
It is used to measure subjectively perceived pain. On the scale, which includes the numbers between 0 and 10 cm, which are the most commonly used to determine the intensity of pain quantitatively, with painlessness at one end and the most severe pain possible at the other end, "0" defines painlessness and "10" defines the most severe pain.
Visual Analog Scale for Fatigue
时间窗: 1 year
The fatigue scale is a 10 cm scale that evaluates the severity of fatigue ranked from 0 to 10. On the left side of the scale, there is a rating of "I do not feel tired", and on the right side, there is a rating of "I feel extreme fatigue and exhaustion".
次要结局
未报告次要终点
研究者
Birgul Vural Dogru
Associate Professor
Mersin University