Hospitalized Patients Clinical Trial
Official title:
The Effect of Magnetic Therapy on Pain Relief in Postoperation Patients
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.
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.
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