ConstipationNCT06578442
Effectiveness of Electromagnetic Field Therapy in Chronic Constipation
A study testing Magnetic Field Treatment in people with Constipation, run by Medipol University at 2 sites in Turkey (Türkiye).
Trial summary
This study was, 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. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Magnetic Field Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 28 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of chronic constipation according to Rome III criteria
- Ages of 18-68
- Indicate magnetotherapy treatment,
- Not having used any medication for constipation during the treatment
- Fully cooperative
Who cannot join
- Severely obese patients
- Electrical implants in their body
- Pregnancy
- Implanted inner ear implants
- Small implants that may be affected by the magnetic field
- Epilepsy
- Untreated hypertoid
- High fever
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Medipol University
Istanbul, Beykoz, 34100
Istanbul Gedik University
Istanbul, Istanbul
About this study
Official title: Effects of Transabdominal Magnetic Field Therapy on Constipation Severity in Chronic Functional Constipation: A Randomized Controlled Trial
This study was, 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.
Read more
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.
- Conditions
- Constipation
- Being tested
- Magnetic Field Treatment, Standard Care Group, Sham (No Treatment)
- Keywords
- Quality of Life, Magnetic Fields
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Field TreatmentOther
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.
Standard Care GroupOther
The standard care group received "training on how to manage constipation".
Sham (No Treatment)Other
The sham group underwent the same procedure without active stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Magnetic Field Treatment; Other: Standard Care Group |
| Standard Care Group | Active comparator | Standard Care Group group was given "constipation coping training". Receives: Other: Standard Care Group |
| 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. Receives: Other: Standard Care Group; Other: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Eight weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Feb 2019
- Primary completion28 Apr 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a three-arm, parallel-group interventional study. Participants were randomly assigned to active transabdominal magnetic field therapy, sham intervention, or standard care.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilanur Özkaraoğlu, PT, MSc, Medipol University
- Investigators
- Esra Atilgan, PhD, Principal investigator, Medipol UniversityGizem Boztas Elverisli, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578442
- Sponsor's protocol ID
- E-10840098-50.04-2843
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transabdominal Magnetic Field Therapy on Constipation Severity in Chronic Functional Constipation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06578442
- Acronym / sponsor ID
- E-10840098-50.04-2843
- Conditions
- Constipation
- Keywords
- Quality of Life, Magnetic Fields
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This was a three-arm, parallel-group interventional study. Participants were randomly assigned to active transabdominal magnetic field therapy, sham intervention, or standard care.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Magnetic Field Treatment, Other: Standard Care GroupMagnetic 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. |
| Standard Care Group | Active comparator | Other: Standard Care GroupStandard Care Group group was given "constipation coping training". |
| Sham | Sham comparator | Other: Standard Care Group, Other: Sham (No Treatment)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. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presence of chronic constipation according to Rome III criteria
- Ages of 18-68
- Indicate magnetotherapy treatment,
- Not having used any medication for constipation during the treatment
- Fully cooperative
Key exclusion criteria (8 listed)
- Severely obese patients
- Electrical implants in their body
- Pregnancy
- Implanted inner ear implants
- Small implants that may be affected by the magnetic field
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Field TreatmentMagnetic 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. | Other | Treatment group |
| Standard Care GroupThe standard care group received "training on how to manage constipation". | Other | Sham, Standard Care Group, Treatment group |
| Sham (No Treatment)The sham group underwent the same procedure without active stimulation. | Other | Sham |
Primary outcome
Constipation Severity Instrument (CSI)
Time frame: Eight weeks
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.
4 secondary outcomes
Patient Assessment of Constipation Quality of Life (PAC-QOL)
Time frame: Eight weeks
Bristol Stool Scale
Time frame: Eight weeks
Complete spontaneous bowel movements (CSBM)
Time frame: Eight weeks
Defecation time
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Atilgan, PhD principal investigator
Medipol University
Gizem Boztas Elverisli, PhD principal investigator
Medipol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Field Treatment in people with Constipation, run by Medipol University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation Severity Instrument (CSI) (time frame: Eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.