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This study was a prospective randomise controlled study. The aim of this study was to determine the effect of transabdominal magnetic field therapy on constipation severity in patients with chronic functional constipation.
After eligibility assessment and baseline measurements, participants were randomly allocated into three groups: the transabdominal magnetic field therapy group, the sham group, and the standard care group. All groups received Constipation Management Education. The education program, developed based on the literature, covered the definition, causes, risk factors, medication use, and lifestyle-related factors associated with constipation. In addition, behavioral recommendations were provided, including maintaining regular bowel habits, adopting an appropriate defecation posture, avoiding delayed defecation and excessive straining, and optimizing diet, fluid intake, and physical activity.
The MFT group received active transabdominal magnetic field therapy twice weekly for 8 weeks. The sham group underwent the same device placement and session protocol; however, the device was used without delivering an active magnetic field. The standard care group received only Constipation Management Education. Participants were followed face to face for 8 weeks, and individual counseling was provided when needed to answer their questions.
The primary outcome measure was the Constipation Severity Instrument (CSI). Secondary outcomes were the CSI subscales, the Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL), the Bristol Stool Form Scale, complete spontaneous bowel movements (CSBM), and defecation time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Magnetic Field Treatment was applied to the participants for 30 minutes a day, twice a week for 8 weeks, using an electromagnetic field therapy device, in a supine position, by placing circular magnetotherapy electrodes in the abdominal area, at 25 Hz and 30 Gauss power. |
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| Standard Care Group | Active Comparator | Standard Care Group group was given "constipation coping training". |
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| Sham | Sham Comparator | The sham group underwent the same procedure without active magnetic stimulation. Magnetic Field Therapy was administered to participants in a supine position, with circular magnetotherapy electrodes placed on the abdominal area using an electromagnetic field therapy device. The treatment lasted 30 minutes twice a week for 8 weeks, with no current flowing through the device during the sham application. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Field Treatment | Other | Magnetic Field Treatment was applied to the participants for 30 minutes a day, twice a week for 8 weeks, using an electromagnetic field therapy device, in a supine position, by placing circular magnetotherapy electrodes in the abdominal area, at 25 Hz and 30 Gauss power. |
| Measure | Description | Time Frame |
|---|---|---|
| Constipation Severity Instrument (CSI) | It is a scale that reveals the symptoms of constipation in people. It makes an evaluation to determine the problems experienced by individuals in defecation. The scale includes 16 questions. The lowest total score that can be obtained from the scale is 0 and the highest is 73. A high score indicates that the symptoms are serious. | Eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Assessment of Constipation Quality of Life (PAC-QOL) | Quality of life was assessed using the Turkish adaptation of the Patient Assessment of Constipation Quality of Life(PAC-QOL). The PAC-QOL consists of 28 questions, including subscales for "physical discomfort," "psychosocial discomfort," "concerns/worries," and "satisfaction." The highest possible score is 140, and the lowest is 28. Higher scores indicate that constipation negatively impacts quality of life more significantly. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esra Atilgan, PhD | Medipol University | Principal Investigator |
| Gizem Boztas Elverisli, PhD | Medipol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medipol University | Istanbul | Beykoz | 34100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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This was a three-arm, parallel-group interventional study. Participants were randomly assigned to active transabdominal magnetic field therapy, sham intervention, or standard care.
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| Standard Care Group | Other | The standard care group received "training on how to manage constipation". |
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| Sham (No Treatment) | Other | The sham group underwent the same procedure without active stimulation. |
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| Eight weeks |
| Bristol Stool Scale | This is a scale that evaluates stool consistency. A high score indicates a more liquid stool consistency. Type 3-4 indicates normal stool. | Eight weeks |
| Complete spontaneous bowel movements (CSBM) | This is a medical term referring to bowel movements that occur naturally without medication, and without straining, pain, or a feeling of incomplete emptying during defecation. | Eight weeks |
| Defecation time | It describes the frequency of bowel movements, the consistency of the stool, and the degree of difficulty a person experiences during defecation. It is recorded in minutes. A longer duration indicates difficulty in defecation. | Eight weeks |