The Effect of Magnetic Therapy on Pain Relief in Postoperation Patients

NCT04112745 | Unknown

• 1 other identifier: CMUH108-REC2-092
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgical Patients; Hospitalized Patients

Keywords

Complementary Therapy; Static Magnet; Pain Relief; Hospitalized Patients

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• heart rhythm variation

  Baseline, end of surgery, up until 3 days after surgery.

Study Arms (2)

Experimental group

EXPERIMENTAL

Other: Static magnet

Control group

PLACEBO COMPARATOR

Other: Placebo

Interventions

Static magnet OTHER

Static magnet with 2,000 Gauss

Experimental group

Placebo OTHER

Polyvinyl chloride resin material black jewelry

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University

Taichung, Taiwan

RECRUITING

Related Publications (31)

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Study Officials

• Shwn-Huey Shieh, PhD

  China Medical University Hospital

  STUDY CHAIR

Central Study Contacts

Shwn-Huey Shieh, PhD

CONTACT

00886-04-22053366; shshieh@mail.cmu.edu.tw

Shang-Jung Wu, PhD candidate

CONTACT

00886-920940298; ernr1191@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2019
• First Posted: October 2, 2019
• Study Start: October 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 2, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)