Pelvic FloorNCT04687852
Comparison of the Efficacy of Pharmacology and Non-pharmacological Treatment in Women With Primary Dysmenorrhea.
A study testing Conservative and Non-conservative treatments in people with Pelvic Floor and Exercise, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Primary dysmenorrhea is a common problem in women. Women use many treatment methods to deal with primary dysmenorrhea. Therefore, this study aims to find the most effective treatment by determining the effectiveness of conservative and non-conservative treatment in women with primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor, Exercise, Telerehabilitation
- What is being tested?
- Conservative and Non-conservative treatments
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jul 2021to 10 Dec 2021
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Over the age of 18 whose menstrual cycle continues,
- Primary dysmenorrhea was diagnosed by the obstetrician by ultrasonographic evaluation.
- Participants who agree to participate in the study will be included.
- Participants in the diosmin group who were prescribed diosmin by the physician
- Participants in the NSAI group who were prescribed an NSAI by the physician
Who cannot join
- Receiving hormone therapy
- Those receiving psychiatric treatment for stress disorder or anxiety
- Intrauterine contraceptive device
- Using birth control pills
- Women diagnosed with secondary dysmenorrhea
- With neurological deficits
- Patients who were not suitable for NSAI and Diosmin treatment by the physician were excluded by the physician and were not included in our study.
Trial locations and contacts
1 site in 1 country.
About this study
Primary dysmenorrhea is a common problem in women. Women use many treatment methods to deal with primary dysmenorrhea. Therefore, this study aims to find the most effective treatment by determining the effectiveness of conservative and non-conservative treatment in women with primary dysmenorrhea. Another aim of the study is to generalize the use of conservative treatment methods in the treatment of primary dysmenorrhea.On the other hand, it aims to spread the telerehabilitation method, which allows the global Covid 19 outbreak to be maintained remotely online, in the world and in our country.
Read the detailed description
This study aims to determine the effects of different treatment approaches in women diagnosed with primary dysmenorrhea. Patients who are examined by a physician and diagnosed with primary dysmenorrhea using ultrasonography will be included in the study. The cases will be divided into 5 groups by randomization. In the first group, patients who are prescribed diosmin by the attending physician will be taken. The second group; Patients who are prescribed naproxen sodium by the attending physician will be taken. The third group; Pelvic floor exercises will be performed 2 days a week and 12 weeks a week using the motor imagination technique created by the women health physiotherapist. In the fourth group, acupressure technique applied by applying pressure to non-invasive acupuncture points will be applied daily for 12 weeks. The fifth group will be the control group. Online access will be synchronized with the phone or computer, and training sessions will not be recorded to protect the patient's personal information. Cases will be evaluated online at the beginning of the study and at the end of the 12-week program.
- Conditions
- Pelvic Floor, Exercise, Telerehabilitation, Acupressure, Dysmenorrhea Primary, Drug Effect
- Being tested
- Conservative and Non-conservative treatments
- Keywords
- Pelvic Floor, Dysmenorrhea Primary, Drug therapy, Telerehabilitation, Acupressure
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative and Non-conservative treatmentsOther
This program includes Focused Pelvic Floor with Motor Imagery Technique Group ,Nonsteroidal Anti-Inflammatory Drug Group, Diosmin Group, Acupressure Group (LI-4 (Bilateral), CV-6, CV-4, SP-6 (Bilateral). It is aimed to determine the most effective treatment among these groups.
| Study group | Role | What they receive |
|---|---|---|
| Focused Pelvic Floor Exercise with Motor ImageryTechnique Group | Experimental | 5 minute-Meditation Therapy 10 minute-Progressive Relaxation training ( Bernstein-Borkovec Method) 5 min - Breathing Exercises (Diaphragmatic Breathing Exercise, Pursed lip breathing Exercise) 35 min -Motor Imagery Technique Focused Pelvic Floor Exercises-MOPEXE 5 min - Meditation Therapy Twice a week for 60 minutes 12 weeks Participants will be evaluated online at the beginning of the research and at the end of the 12-week program. Receives: Other: Conservative and Non-conservative treatments |
| Nonsteroidal Anti-Inflammatory Drug(NSAID) Group | Active comparator | Naproxen Sodium 550 mg film-coated tablet prescribed by the physician will be given to patients. During the menstrual period, 1 or 2 times a day will be used depending on the pain of the patient. Treatment time; 12 weeks. Receives: Other: Conservative and Non-conservative treatments |
| Diosmin Group | Other | Diosmin (90%) 500 mg film-coated tablets prescribed by the physician will be given to patients. During the menstrual period, 1 or 2 times a day will be used depending on the patient's pain. Treatment time; 12 weeks. Receives: Other: Conservative and Non-conservative treatments |
| Acupressure Group | Experimental | 4 acupuncture points will be applied twice a day for 12 weeks. These points are; LI4, CV4, CV6, SP6
. Receives: Other: Conservative and Non-conservative treatments |
| Control Group | No intervention | Participants will not be treated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Information Form
Participants age, height, weight, educational status, marital status, exercise habits will be recorded. In addition, sociodemographic information, clinical features such as background and family history; Information on menarche age, average cycle duration and menstruation duration, and methods of coping with dysmenorrhea were recorded.
Measured: 5 minutes
Visual Analogue Scale (VAS)
The Visual Analogue Scale (VAS) is used to convert non-numerical values to digital. The value 0 means I have no pain, 10 means I have unbearable pain. The person marks his pain on this ruler. It measures the intensity of the pain.
Measured: 2 minutes
McGill Pain Questionnaire
The characteristic of pain felt by the patients during menstruation was evaluated using the McGill Pain Questionnaire-Short Form,With the McGill Melzack Pain Questionnaire, the location of the pain, the feeling it creates in the individual, its relationship with time, its severity and the level of viable pain for the individual are determined. High score indicates high level of pain
Measured: 5 minutes
Ultrasonography (US)
Ultrasonography is a soft tissue examination method.Its biggest advantages are that it is an easily accessible method and does not contain ionizing radiation.
In the evaluation by ultrasonography, dysmenorrhea due to organic problems will be evaluated and excluded by the obstetrician.
Measured: 5 minutes
Secondary outcomes (1)
Menstrual Attitude Questionnaire
The Turkish version of the Menstrual Attitude Scale (MBI) will be applied to determine the attitudes and behaviors of the participants during the menstrual period. Menstruation attitude scale includes 5 subtitles. These subheadings are;
- Menstruation as a debilitating event
- Menstruation as a bothersome event
- Menstruation as a natural event
- Ancipitation and prediction of the onset of menstruation
- Denial of any effect of menstruation
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start9 Jul 2021
- Primary completion9 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FloorStudies of the same condition, open and under way.
- 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
- Randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gizem BOZTAŞ ELVERİŞLİ, Phd, Study director, Istanbul Medipol Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687852
- Sponsor's protocol ID
- 10840098-604.01.01-E.66761
- Status last verified
- Jun 2021
- First submitted
- 10 Dec 2020
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Pharmacology and Non-pharmacological Treatment in Women With Primary Dysmenorrhea.
- ClinicalTrials.gov ID
- NCT04687852
- Acronym / sponsor ID
- 10840098-604.01.01-E.66761
- Conditions
- Pelvic Floor, Exercise, Telerehabilitation, Acupressure, Dysmenorrhea Primary, Drug Effect
- Keywords
- Pelvic Floor, Dysmenorrhea Primary, Drug therapy, Telerehabilitation, Acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 29 Dec 2020 (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.
Primary dysmenorrhea is a common problem in women. Women use many treatment methods to deal with primary dysmenorrhea. Therefore, this study aims to find the most effective treatment by determining the effectiveness of conservative and non-conservative treatment in women with primary dysmenorrhea. Another aim of the study is to generalize the use of conservative treatment methods in the treatment of primary dysmenorrhea.On the other hand, it aims to spread the telerehabilitation method, which allows the global Covid 19 outbreak to be maintained remotely online, in the world and in our country.
Detailed description
This study aims to determine the effects of different treatment approaches in women diagnosed with primary dysmenorrhea. Patients who are examined by a physician and diagnosed with primary dysmenorrhea using ultrasonography will be included in the study. The cases will be divided into 5 groups by randomization. In the first group, patients who are prescribed diosmin by the attending physician will be taken. The second group; Patients who are prescribed naproxen sodium by the attending physician will be taken. The third group; Pelvic floor exercises will be performed 2 days a week and 12 weeks a week using the motor imagination technique created by the women health physiotherapist. In the fourth group, acupressure technique applied by applying pressure to non-invasive acupuncture points will be applied daily for 12 weeks. The fifth group will be the control group. Online access will be synchronized with the phone or computer, and training sessions will not be recorded to protect the patient's personal information. Cases will be evaluated online at the beginning of the study and at the end of the 12-week program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Focused Pelvic Floor Exercise with Motor ImageryTechnique Group | Experimental | Other: Conservative and Non-conservative treatments5 minute-Meditation Therapy 10 minute-Progressive Relaxation training ( Bernstein-Borkovec Method) 5 min - Breathing Exercises (Diaphragmatic Breathing Exercise, Pursed lip breathing Exercise) 35 min -Motor Imagery Technique Focused Pelvic Floor Exercises-MOPEXE 5 min - Meditation Therapy Twice a week for 60 minutes 12 weeks Participants will be evaluated online at the beginning of the research and at the end of the 12-week program. |
| Nonsteroidal Anti-Inflammatory Drug(NSAID) Group | Active comparator | Other: Conservative and Non-conservative treatmentsNaproxen Sodium 550 mg film-coated tablet prescribed by the physician will be given to patients. During the menstrual period, 1 or 2 times a day will be used depending on the pain of the patient. Treatment time; 12 weeks. |
| Diosmin Group | Other | Other: Conservative and Non-conservative treatmentsDiosmin (90%) 500 mg film-coated tablets prescribed by the physician will be given to patients. During the menstrual period, 1 or 2 times a day will be used depending on the patient's pain. Treatment time; 12 weeks. |
| Acupressure Group | Experimental | Other: Conservative and Non-conservative treatments4 acupuncture points will be applied twice a day for 12 weeks. These points are; LI4, CV4, CV6, SP6 . |
| Control Group | No intervention | –Participants will not be treated. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Over the age of 18 whose menstrual cycle continues,
- Primary dysmenorrhea was diagnosed by the obstetrician by ultrasonographic evaluation.
- Participants who agree to participate in the study will be included.
- Participants in the diosmin group who were prescribed diosmin by the physician
- Participants in the NSAI group who were prescribed an NSAI by the physician
Key exclusion criteria (7 listed)
- Receiving hormone therapy
- Those receiving psychiatric treatment for stress disorder or anxiety
- Intrauterine contraceptive device
- Using birth control pills
- Women diagnosed with secondary dysmenorrhea
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 |
|---|---|---|
| Conservative and Non-conservative treatmentsThis program includes Focused Pelvic Floor with Motor Imagery Technique Group ,Nonsteroidal Anti-Inflammatory Drug Group, Diosmin Group, Acupressure Group (LI-4 (Bilateral), CV-6, CV-4, SP-6 (Bilateral). It is aimed to determine the most effective treatment among these groups. | Other | Acupressure Group, Diosmin Group, Focused Pelvic Floor Exercise with Motor ImageryTechnique Group, Nonsteroidal Anti-Inflammatory Drug(NSAID) Group |
Primary outcome
Demographic Information Form
Time frame: 5 minutes
Participants age, height, weight, educational status, marital status, exercise habits will be recorded. In addition, sociodemographic information, clinical features such as background and family history; Information on menarche age, average cycle duration and menstruation duration, and methods of coping with dysmenorrhea were recorded.
Visual Analogue Scale (VAS)
Time frame: 2 minutes
The Visual Analogue Scale (VAS) is used to convert non-numerical values to digital. The value 0 means I have no pain, 10 means I have unbearable pain. The person marks his pain on this ruler. It measures the intensity of the pain.
McGill Pain Questionnaire
Time frame: 5 minutes
The characteristic of pain felt by the patients during menstruation was evaluated using the McGill Pain Questionnaire-Short Form,With the McGill Melzack Pain Questionnaire, the location of the pain, the feeling it creates in the individual, its relationship with time, its severity and the level of viable pain for the individual are determined. High score indicates high level of pain
Ultrasonography (US)
Time frame: 5 minutes
Ultrasonography is a soft tissue examination method.Its biggest advantages are that it is an easily accessible method and does not contain ionizing radiation. In the evaluation by ultrasonography, dysmenorrhea due to organic problems will be evaluated and excluded by the obstetrician.
1 secondary outcome
Menstrual Attitude Questionnaire
Time frame: 5 minutes
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 24 May 2022.
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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.
Gizem BOZTAŞ ELVERİŞLİ, Phd study director
Istanbul Medipol Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative and Non-conservative treatments in people with Pelvic Floor and Exercise, run by Istanbul Medipol University Hospital at 1 site 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 7 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 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Demographic Information Form (time frame: 5 minutes). The study lists 4 primary outcomes in all. 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 24 May 2022.