- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07314021
Primær Dysmenoré og Mobilisering.
28. juni 2026 opdateret af: ZEYNEP BETÜL BİLGİ, Medipol University
Sammenligning af den strukturelle FEMOB-mobiliseringsteknik og MOPEXE-træningsmodellen hos kvinder med primær dysmenoré
42 kvinder diagnosticeret med primær dysmenoré blev inkluderet i undersøgelsen og opdelt i tre grupper.
den første gruppe modtog behandling med en mobiliseringsmetode, den anden gruppe modtog bevægelsesforestillingsfokuserede øvelser og den tredje gruppe, som en kontrolgruppe, modtog elektroterapi.
alle tre grupper modtog elektroterapi.
den første gruppe modtog behandling med en mobiliseringsmetode, den anden gruppe modtog bevægelsesforestillingsfokuserede øvelser og den tredje gruppe, som en kontrolgruppe, modtog elektroterapi.
alle tre grupper modtog elektroterapi.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
72
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Istanbul, Tyrkiet (Türkiye), 34000
- Medipol University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- primær dysmenorre
Eksklusionskriterier:
- en kontraindikeret tilstand
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: CONTROL
Participants in the control group received no active treatment, exercise program, or physiotherapy intervention during the study period.
They were instructed to continue their routine daily activities and not to initiate any new pharmacological or non-pharmacological treatment for dysmenorrhea symptoms during the study.
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Aktiv komparator: FEMOB
Structured multimodal mobilization (FEMOB) is a manual therapy-based mobilization protocol consisting of temporomandibular, occipitosacral, and sacroiliac joint mobilizations, abdominal myofascial release, and kinesio taping.
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FEMOB is a structured multimodal mobilization protocol consisting of temporomandibular, occipitosacral, and sacroiliac joint mobilizations, abdominal myofascial release, and kinesio taping.
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Aktiv komparator: MOPEXE
Participants in the MOPEXE arm receive a 60-minute Pilates-based motor imagery-focused pelvic floor exercise program twice weekly for 12 weeks.
Each session consists of 5 minutes of meditation, 10 minutes of progressive relaxation training using the Bernstein-Borkovec method, 5 minutes of diaphragmatic and pursed-lip breathing exercises, 35 minutes of motor imagery-focused pelvic floor exercises, and a final 5 minutes of meditation.
Outcomes are assessed at baseline and after completion of the 12-week intervention period.
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MOPEXE is a Pilates-based motor imagery-focused pelvic floor exercise program.
Each 60-minute session consists of 5 minutes of meditation, 10 minutes of progressive relaxation training using the Bernstein-Borkovec method, 5 minutes of diaphragmatic and pursed-lip breathing exercises, 35 minutes of motor imagery-focused pelvic floor exercises, and a final 5 minutes of meditation.
Sessions are delivered twice weekly for 12 weeks.
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Andet: Conventional treatment group
The conventional treatment arm receives TENS and hot pack application.
TENS is administered with the Chattanooga Intelect Advanced Combo system at 100 Hz and 200 µs for 30 minutes using two channels and four electrodes placed over the lumbar and suprapubic regions.
Hot pack application is applied to the lumbar and suprapubic regions for a total of 20 minutes.
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The conventional treatment arm receives TENS and hot pack application.
TENS is administered with the Chattanooga Intelect Advanced Combo system at 100 Hz and 200 µs for 30 minutes using two channels and four electrodes placed over the lumbar and suprapubic regions.
Hot pack application is applied to the lumbar and suprapubic regions for 20 minutes.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Short-Form McGill Pain Questionnaire Total Pain Score
Tidsramme: 12 weeks
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Pain intensity was assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ).
The SF-MPQ total pain score, calculated as the sum of sensory and affective pain descriptor scores, was defined as the primary outcome.
Higher scores indicate greater pain severity.
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12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Menstrual Attitude Questionnaire
Tidsramme: 12 weeks
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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;
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12 weeks
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Functional and Emotional Dysmenorrhea Scale
Tidsramme: 12 weeks
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This is a 14-item, 5-point Likert-type scale used to measure dysmenorrhea functionally and emotionally.
There are no reverse items in the scale.
The scale was developed to provide functional and emotional measurement of dysmenorrhea.
As the scores obtained from the scale increase, the extent to which patients are functionally and emotionally affected by dysmenorrhea also increases.
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12 weeks
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Menstrual Symptom Questionnaire
Tidsramme: 12 weeks
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The scale consists of 22 items that inquire about menstrual symptoms and is scored on a five-point Likert scale, from never (1) to always (5).
The scale, which consists of three sub-dimensions, is evaluated in the sub-dimension of 'Negative effects/somatic complaints' with items 1-13, the sub-dimension of 'Menstrual pain symptoms' with items 14-19, and the sub-dimension of 'Coping methods' with items 20-22.
An increase in the mean score indicates an increase in the severity of menstrual symptoms related to the relevant sub-dimension.
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12 weeks
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The Menstrual Distress Questionnaire
Tidsramme: 12 weeks
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This is a self-reported assessment tool designed to comprehensively evaluate the physical and emotional symptoms experienced by individuals during their menstrual period.
The scale consists of 25 questions, each with 5 sub-items, covering common symptoms such as abdominal pain, headache, nausea, irritability, and mood swings.
Each item is scored using a Likert-type rating system to determine the frequency or severity with which the participant experiences the relevant symptom.
As the total score on the scale increases, the intensity of the symptoms experienced during menstruation and their negative impact on daily life also increase.
In this context, high scores indicate increased symptom severity and decreased quality of life.
The scale offers a holistic assessment by encompassing both the somatic and emotional dimensions of menstruation-related symptoms.
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12 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. december 2025
Primær færdiggørelse (Faktiske)
1. juni 2026
Studieafslutning (Faktiske)
1. juni 2026
Datoer for studieregistrering
Først indsendt
4. december 2025
Først indsendt, der opfyldte QC-kriterier
30. december 2025
Først opslået (Faktiske)
2. januar 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- E-10840098-202.3.02-4605
Plan for individuelle deltagerdata (IPD)
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IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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