The Effect of Magnetic Therapy on Pain Relief in Postoperation Patients

Hospitalized Patients Clinical Trial

Official title:

The Effect of Magnetic Therapy on Pain Relief in Postoperation Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04112745
• Other study ID #: CMUH108-REC2-092
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2019
• Source: China Medical University Hospital
• Contact: Shwn-Huey Shieh, PhD
• Phone: 00886-04-22053366
• Email: shshieh[@]mail.cmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

In this study, we adopted a double-blind randomized research design to investigate the effectiveness of magnetic complementary therapy in relieving pain in hospitalized patients. The outcomes of experimental group and the control group were repeatedly measured. Both groups received routine care and pain relief treatment, but the interventions were different: the participants of experimental group was adhered with magnets, and the control group with placebo.

Participants are randomly assigned to the experimental group and the control group, and the magnets or placebos are placed into the zipper bag and marked with serial numbers 1 to 100. When the cases are conducted in the study, the researchers take out the serial number zipper bag and paste it to the serial number. After the data collection, the researchers will identify the experimental and the control group according to the random table and the study case number.

The intervention materials are pre-packaged. Because the intervention materials (magnet and placebo) look exactly the same, none of the study subjects, the researchers who perform the sticking intervention material, and the physiological indicators monitoring were aware of the study case as an experimental group or a control group.

Interventions are implemented by the personnel including 1. Material assemblers: After a list of random numbers will be calculated by the randomizer, four pieces of magnets or placebos are arranged in each bag according to the random number table. 2. Magnet/placebo adhesion and evaluator: intervention adhesion and assessment of physiological indicators and rhythm variation measurements.

Research steps:

1. Screening for eligible cases.

2. Random assignment to the experimental group and the control group.

3. Pretest data collection: Pretest data collection is performed the day before surgery.

4. Day of surgery: According to the medical records, the researchers fill in the disease characteristics, including the name of the operation, the surgical site, the indwelling of the tube, and the total length of the wound. According to the case number, the magnet or the placebo, is pasted to the corresponding position of the healthy side limb.

5. On the first and second days after surgery, posttest data collection will be performed, including pain sensations: concise pain scale and anxiety scale; physiological indicators assessment and heart rhythm variation assessment.

6. On the 3rd day after surgery, the intervention material will be removed and posttest data will be collected. The researchers use the random table and the case number to identify the experimental and the control group.

Data analysis methods:

The collected quantitative data are encoded and analyzed by SPSS 24.0 statistical software package. According to the research variable attributes, the distributions of the independent variables and the dependent variables are verified by descriptive statistics, including the frequency distribution, percentage, average, and standard deviation. Inferential statistical analysis are 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Prepare for surgery for adults.

2. The communicator is clear in Mandarin and Taiwanese.

3. Those who are willing to participate in this study and sign a consent form.

4. The patient has no history of arrhythmia or severe cardiopulmonary disease.

5. No allergies to adhesive fixtures.

Exclusion Criteria:

1. Patients with cancer or chronic pain that lasts for more than 6 months.

2. Those with effects on the accuracy of autonomic nervous system measurements: such as autonomic neuropathy.

3. Patients with excessive anxiety and nervousness who are unable to cooperate with the study.

4. A person who abuses painkillers or narcotic drugs.

5. Patients use electromagnetic medical supplies such as heart rhythms.

Related Conditions & MeSH terms

• Hospitalized Patients
• Surgical Patients

Intervention

Other:
• Static magnet
Static magnet with 2,000 Gauss
• Placebo
Polyvinyl chloride resin material black jewelry

Locations

Country	Name	City	State
Taiwan	China Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scale	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.	Baseline, end of surgery, up until 3 days after surgery.
Primary	Anxiety scale	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.	Baseline, end of surgery, up until 3 days after surgery.
Secondary	heart rhythm variation	After lying flat for 10 minutes, take a 5-minute heart rate change measurement. Due to the measurement of time, mood and position will affect the variability of heart rhythm.	Baseline, end of surgery, up until 3 days after surgery.