跳至主要内容
临床试验/NCT04112745
NCT04112745Unknown不适用

The Effect of Magnetic Therapy on Pain Relief in Postoperation Patients

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2019年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
220
试验地点
1
主要终点
Pain scale

研究概览

简要总结

Using Complementary therapies with conventional treatments to relieve pain can reduce the patient's medical expenses and increase the patient's psychological feeling of self-control of the body. Static magnetic therapy is one of the non-invasive complementary therapies. The aim of this study was to explore the effect of static magnetic therapy on pain relief in hospitalized patients.

In this study, a quasi-experimental design with double-blind randomization method was proposed. 220 inpatients in a teaching hospital in central Taiwan were selected as the research subjects, and divided into experimental group and control group of 110. SPSS software package was used for descriptive and inferential statistical analysis in this study. For descriptive statistical analysis, frequency distribution, percentage, mean, and standard deviation were utilized. Inferential statistical analysis was applied with Chi-square test, Pearson's correlation, t-test, ANOVA, and Generalized Estimating Equations (GEE). The P value of significance level was set less than 0.05.

详细描述

Research Motivation and Research Issues:

The National Institutes of Health proposed six important strategies for pain management: studying the characteristics and needs of pain populations, prevention and care, identifying barriers and exclusions for pain care, providing individual pain care, professional education and training, and public awareness and communication. 80-100% of surgical patients experienced acute pain after surgery, and about 61-92% of postoperative patients experienced moderate or severe pain, and less than half of patients undergoing surgery showed that postoperative pain were alleviated. In the emergency treatment of musculoskeletal trauma patients, 40.9% of patients received medication. After pain treatment, only 12.5% of patients felt pain relief, and 23% of patients still felt moderate to severe pain when they left the emergency department. When pain is not properly relieved, it will have a negative impact on the patient, including quality of life and recovery of physical function, risk of complications, and even ineffective communication between doctors and patients. Proper pain assessment and care by caregivers can affect the effectiveness of pain relief in patients. Complementary therapy, in combination with conventional medicine, is one of the effective ways to relieve pain by reducing drug and medical costs and increasing the patient's self-care and autonomy. Complementary therapies can be divided into three broad categories: the first is natural products that are ingested through inhalation, external use or oral intake, including herbs, vitamins, minerals and probiotics. The second category is physical and mental interventional therapy, including art therapy, cognitive therapy, prayer, chanting, meditation, and energy complementary therapy, such as magnetic energy therapy. The third category is other categories such as local traditional therapy, Ayurvedic medicine, traditional Chinese medicine, homeopathy and natural remedies.

Magnetic therapy is a form of energy complementary therapy, which is the use of magnetic energy to produce energy for the relief or healing of diseases, usually divided into static magnetic therapy and dynamic electromagnetic therapy. In the implementation of magnetic therapy, there is no invasive treatment of pain and discomfort, no damage, so it is easy to be accepted by the public. The U.S. and Canada spend more than $500 million on static magnetic therapy to relieve pain, and global consumer spending exceeds $5 billion. The magnetic field has the effect of two distinct magnetic poles. The positive magnetic pole effect has the functions of oxidation, activation, excitation and pressure increase, and the negative magnetic pole effect has the functions of reduction, alkalization, relaxation, sedation and pressure resistance. Most of the research literature didn't show magnetic poles.

Therefore, this study focuses on the effect of magnetic complementary therapy on pain relief, in order to explore the magnetic therapy method and effect of pain relief.

Research design:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Prepare for surgery for adults.
  • The communicator is clear in Mandarin and Taiwanese.
  • Those who are willing to participate in this study and sign a consent form.
  • The patient has no history of arrhythmia or severe cardiopulmonary disease.
  • No allergies to adhesive fixtures.

排除标准

  • Patients with cancer or chronic pain that lasts for more than 6 months.
  • Those with effects on the accuracy of autonomic nervous system measurements: such as autonomic neuropathy.
  • Patients with excessive anxiety and nervousness who are unable to cooperate with the study.
  • A person who abuses painkillers or narcotic drugs.
  • Patients use electromagnetic medical supplies such as heart rhythms.

研究组 & 干预措施

Experimental group

Experimental

干预措施: Static magnet (Other)

Control group

Placebo Comparator

干预措施: Placebo (Other)

结局指标

主要结局

Pain scale

时间窗: Baseline, end of surgery, up until 3 days after surgery.

The pain scale was calculated according to Brief Pain Inventory Short Form (BPI). The evaluation score was 0-10 points, with 0 being no pain and 10 being the worst pain. The classification scheme for average pain was 0-3 for mild, 4-6 for moderate, and 7-10 for severe.

Anxiety scale

时间窗: Baseline, end of surgery, up until 3 days after surgery.

The anxiety scale was calculated according to Hospital Anxiety and Depression Scale- Anxiety (HADS-A) which contained 7 items. This scale took the Likert scoring method, scoring 0-3, 0 points for never, 3-point for always. The score range was 0-21 points. A higher score indicated more anxious. The classification scheme for average anxiety was 0-7 for no anxiety, 8-10 for mild, 11-14 for moderate, and 15-21 for severe.

次要结局

  • heart rhythm variation(Baseline, end of surgery, up until 3 days after surgery.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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