Effekten af kognitiv træningsterapitilgang og yoga hos unge med dysmenoré
25. august 2026 opdateret af: Dilek Cagri, Acibadem University
Effekten af telerehabiliteringsbaseret kognitiv træningsterapitilgang og yoga på smerter, fysisk funktion og livskvalitet hos unge med dysmenoré
Dysmenoré er en tilstand, der negativt påvirker livskvaliteten hos kvinder i mange aldersgrupper.
Hos piger med dysmenoré i teenageårene er der effekt på skolepræstationer, selvtillid-depressionsproblemer og nedsat livskvalitet på grund af smerter.
For at eliminere disse negative virkninger bør de have en god behandling.
Medicinsk behandling forsøger normalt at minimere og afbalancere denne situation.
I betragtning af det faktum, at familier ikke ønsker at bruge stoffer såsom orale præventionsmidler til deres børn i denne alder og risikoen ved orale præventionsmidler, er forældre i forskellige søgninger.
I betragtning af at tilgangen til smerte altid skal være fra et holistisk perspektiv, er yoga og kognitiv træningsterapi tilgange begge biopsykosociale behandlingsmetoder inden for rammerne af sind-krop integritet.
Yoga og kognitiv træningsterapi tilgang menes at reducere symptomer, forbedre fysiske funktioner og livskvalitet hos unge piger.
Med disse positive effekter falder skolefraværet, depression og selvtillid forbedres.
Sundhedsomkostningerne vil også blive reduceret i et vist omfang.
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Denne undersøgelse var designet som en prospektiv, randomiseret, kontrolleret, parallel gruppeundersøgelse.
Undersøgelsens population bestod af patienter, der søgte til gynækologi- og obstetriske specialister i Istanbul.
G-Power statistisk og kvalitativ dataanalysesoftware version 3.1.9.2 blev brugt til at estimere den stikprøvestørrelse, der kræves til undersøgelsen. I betragtning af, at undersøgelsen bestod af i alt tre parallelle grupper, der skulle måles på tre forskellige tidspunkter og effektstørrelsen f=0,25, α fejlniveau 0,05, effekt (1-β fejlniveau) 0,80, den samlede stikprøvestørrelse blev beregnet til 36. Når den estimerede andel af forsøgspersoner, der kunne gå tabt til opfølgning, blev taget til 20 %, blev det beregnet, at mindst 45 forsøgspersoner skulle inkluderes i undersøgelsen.
1. interventionsgruppe vil modtage kognitiv træningsterapi tilgang, 2. interventionsgruppe vil modtage yoga, og 3. kontrolgruppe vil bestå af personer, der modtager rutinemæssig medicinsk behandling. For fuldt ud at demonstrere effektiviteten af interventionerne, for at reducere bias og sikre homogenitet mellem trænings- og kontrolgrupperne, vil allokeringen til grupperne blive bestemt i randomiser-organisationen. program.
Yoga og kognitiv træningsterapi tilgang vil blive anvendt af en fysioterapeut, der har uddannelse inden for begge områder. Behandlingerne fortsætter to gange om ugen i 12 uger. Efter den indledende vurdering af sagerne vil der i den første uge (2 sessioner) blive gennemført en-til-en, ansigt-til-ansigt træninger for at sikre deres overensstemmelse med behandlingen og for fuldt ud at forstå behandlingsmetoden. Herefter vil behandlinger blive gennemført synkront med patienterne 2 gange om ugen via online platformen (Zoom).
Evalueringer vil blive udført 3 gange som forbehandling, 6. uge og 12. uge. Alle evalueringer vil blive foretaget ansigt til ansigt i den relevante klinik.
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
45
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: Alis Kostanoğlu, Assoc. Prof.
- E-mail: Akostanoglu@bezmialem.edu.tr
Undersøgelse Kontakt Backup
- Navn: Dilek Çağrı Arslan, Lecturer
- Telefonnummer: +902165004182
- E-mail: Dilek.Cagri@acibadem.edu.tr
Studiesteder
-
-
Ataşehir
-
Istanbul, Ataşehir, Tyrkiet (Türkiye), 34752
- Rekruttering
- Acibadem Mehmet Ali Aydinlar University
-
Kontakt:
- Dilek ÇAĞRI ARSLAN, Lecturer
- Telefonnummer: +90539964
- E-mail: Dilek.Cagri@acibadem.edu.tr
-
-
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
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- At blive diagnosticeret med dysmenoré af en gynækolog og fødselslæge,
- er i alderen 10-19,
- At kunne læse og skrive tyrkisk,
- Frivilligt til at deltage i undersøgelsen.
Ekskluderingskriterier:
- At blive diagnosticeret med sekundær dysmenoré,
- At blive diagnosticeret med en anden gynækologisk sygdom,
- Har alvorlige komorbiditeter (neurologiske og/eller kardiovaskulære og/eller muskuloskeletale lidelser, psykiatriske, gastrointestinale, autoimmune),
- Har en historie med kirurgi, der involverer abdominalregionen, bækkenregionen og rygsøjlen inden for det sidste år,
- Tidligere erfaring med yoga og kognitiv træningsterapi tilgange,
- Personer, der deltager aktivt i en anden undersøgelse, vil ikke blive inkluderet i undersøgelsen.
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)
Antal våben
3
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Kognitiv træningsterapi tilgang
Kognitiv træningsterapi sessioner vil bestå af øvelser med forskellige bevægelser i en session, og øvelserne vil blive arbejdet med åndedrætskontrol, ledsaget af en fysioterapeut.
|
Det vil fortsætte to gange om ugen i 12 uger.
Efter den indledende evaluering af sagerne, vil der blive givet en-til-en træning ansigt til ansigt med patienten i den første uge (2 sessioner) for at sikre deres overensstemmelse med behandlingen og for fuldt ud at forstå behandlingsmetoden .
Derefter vil behandlinger blive gennemført synkront med patienterne to gange om ugen via online platformen (Zoom).
|
|
Eksperimentel: Yoga program
Yoga-sessionerne vil bestå af øvelser med forskellige bevægelser i en session, og øvelserne vil blive trænet med åndedrætskontrol, ledsaget af en fysioterapeut.
|
Det vil fortsætte to gange om ugen i 12 uger.
Efter den indledende evaluering af sagerne vil der blive givet en-til-en træning ansigt til ansigt med patienten i den første uge (2 sessioner) for at sikre deres overensstemmelse med behandlingen og for fuldt ud at forstå behandlingsmetoden .
Derefter vil behandlinger blive gennemført synkront med patienterne to gange om ugen via online platformen (Zoom).
|
|
Andet: Routine Medical Treatment
Participants in this group continue to receive the routine medical treatment recommended by their physician.
No structured exercise programme or education is provided within the scope of the study.
|
Vurderinger af personer i denne gruppe vil blive foretaget ansigt til ansigt i den relevante klinik.
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain intensity (VAS)
Tidsramme: Baseline and each menstrual cycle occurring during the 12-week intervention period (approximately three cycles)
|
In the 10 cm VAS, which is the most widely used, reliable and valid scale in the evaluation of pain intensity all over the world, the left end of the line will be formed as "0 = no pain" and the other end as "10 = unbearable pain".
The subjects will be given paper in the form of a pain diary to mark during their menstrual periods and will be asked to mark the point appropriate to the intensity of pain 2 days before, 1 day before, on the 1st, 2nd and 3rd day of menstruation.
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Baseline and each menstrual cycle occurring during the 12-week intervention period (approximately three cycles)
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Fysisk funktion (fleksibilitet)
Tidsramme: Det vil blive gjort 3 gange: før behandlingen, i 6. uge og i 12. uge.
|
Sit-Reach Test: Fleksibiliteten for de forsøgspersoner, der deltager i undersøgelsen, vil blive evalueret med en standard sit-and-reach-boks (Sit and Reach Trunk Flexibility Assessment Testing Box, Baseline, NY, USA).
|
Det vil blive gjort 3 gange: før behandlingen, i 6. uge og i 12. uge.
|
|
Fysisk funktion (perifer muskelstyrke)
Tidsramme: Det vil blive gjort 3 gange: før behandlingen, i 6. uge og i 12. uge.
|
Perifer muskelstyrke: For at evaluere forsøgspersonernes perifere muskelstyrke vil hoftebøjere, hofteekstensorer og hofteabduktorer blive evalueret med et håndholdt dynamometer i begge ben.
|
Det vil blive gjort 3 gange: før behandlingen, i 6. uge og i 12. uge.
|
|
Fysisk funktion (hjerterytmevariabilitet)
Tidsramme: Det gøres 3 gange: inden behandlingen, i den 6. uge og i den 12. uge.
|
Pulsvariabilitet: Hjertefrekvensvariabilitet (HRV) definerer den autonome modulering af hjerterytmen.
Det afspejler parasympatisk aktivitet og sympatisk/parasympatisk nervesystembalance.
Neuroimaging -undersøgelser har vist, at nociceptiv stimulering er tæt knyttet til autonom nervesystemaktivitet.
Smerter kan forårsage et fald i parasympatisk aktivitet, en stigning i sympatisk aktivitet og sympatisk ubalance.
Autonom nervesystem Ubalance forårsaget af sympatisk overaktivitet kan være en anden årsag til primær dysmenorré.
Som svar på ændringer i det ydre miljø opretholder ANS homeostase af det indre miljø i den menneskelige krop gennem samspillet mellem de sympatiske og parasympatiske nerver.
Manglende koordinering mellem de to systemer kan forårsage forskellige symptomer.
Af disse grunde måles og optages hjerterytme variabilitet hos unge piger med primær dysmenorré ved hjælp af den polære H10 -enhed.
|
Det gøres 3 gange: inden behandlingen, i den 6. uge og i den 12. uge.
|
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Education absenteeism
Tidsramme: This procedure will be performed 3 times: through study completion, an average of 3 months
|
Adolescents with dysmenorrhea are typically of school age and may miss several days of school due to dysmenorrhea experienced during their menstrual periods.
Therefore, the school absences of participants in the study will be monitored throughout the process.
School absence rates before and after treatment will be compared.
|
This procedure will be performed 3 times: through study completion, an average of 3 months
|
|
Depression, anxiety, stress level
Tidsramme: It will be done 2 times: before the treatment and 12 weeks after the treatment.
|
Depression-Anxiety-Stress Scale Short Form (DASS-21): Both the original 42-item version of the DASS and the shorter 21-item version have been shown to be reliable and valid scales for measuring depression, anxiety and stress levels, through studies conducted with clinical groups, society and different cultural and ethnic groups.
7 items of DASS-21 include questions about depression, 7 items about anxiety, and 7 items about stress.
Each subscale (depression, anxiety, stress) has a minimum of 0 and a maximum of 21 points.
A low score indicates a good psychological state.
|
It will be done 2 times: before the treatment and 12 weeks after the treatment.
|
|
Dysmenorrhea Impact
Tidsramme: It will be done 2 times: before the treatment and 12 weeks after the treatment.
|
Revised Dysmenorrhea Impact Scale-Short Form (DIS-R): This 13-item scale, which includes cognitive/emotional (8 items) and physiological (5 items) subscales, has been shown to be a valid and reliable measurement tool.
The minimum score on the scale is 0 and the maximum score is 65.
As the scores increase, the functional and emotional impact level of individuals with dysmenorrhea also increases.
|
It will be done 2 times: before the treatment and 12 weeks after the treatment.
|
|
Physical activity
Tidsramme: It will be done 2 times: before the treatment and 12 weeks after the treatment.
|
Physical Activity Questionnaire for Adolescents (PAQ-A): Designed to provide a general estimate of physical activity levels among healthy adolescents, assessing sports participation and activities during and after school, self-administered and based on the last week.
Later, a modified form for adolescents was published.
The Turkish validity and reliability study of the scale was conducted.
8 questions in the scale are scored between 1 and 5, and the 9th question questions the presence of a condition that prevents physical activity during the last week.
A score of '1' corresponds to low-intensity physical activity and a score of '5' corresponds to high-intensity physical activity, but the last question is not included in the scoring.
The total score is obtained by calculating the average score of all questions.
|
It will be done 2 times: before the treatment and 12 weeks after the treatment.
|
|
Patient satisfaction
Tidsramme: This procedure will be performed once: at the 12th week after treatment.
|
The question of whether a patient is improving is fundamental in clinical practice, and the information obtained is important in making decisions regarding prognosis and treatment. Global Rating of Change (GROC) scales are widely used in clinical research, especially in the field of the musculoskeletal system. These scales are a rapid, effective method designed to measure a patient's improvement or worsening over time, usually either to determine the effect of an intervention or to chart the clinical course of a condition. In our study, to measure treatment satisfaction, "-2" means "I am very bad compared to before treatment", "-1" means "I am worse than before treatment", "0" means there is no change compared to before treatment, "1" means I am better than before treatment, "2" means I am very better than before treatment. The Global Rating of Change (GROC) scale will be used in the five-point Likert system. |
This procedure will be performed once: at the 12th week after treatment.
|
|
Adolescent quality of life
Tidsramme: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
|
Pediatric Quality of Life Inventory TM (PedsQL)(Adolescent Form): The PedsQL is a quality of life scale that is suitable for use in both healthy and diseased children and adolescents.
The PedsQL consists of child and parent forms aged 2-18 years.
Since the adolescent group will be included in this study, the 13-18 years old.
Adolescent Form will be used.
Scoring is done in 3 areas.
Firstly, the total scale score (TSS), secondly, the total physical health score (PHSS), and thirdly, the total psychosocial health score (TPHSS), which consists of the calculation of item scores evaluating emotional, social and school functionality, are calculated.
The items are scored between 0-100.
If the answer to the question is marked as never, 100 points are scored; if it is marked as rarely, 75 points are scored; if it is marked as sometimes, 50 points are scored; if it is marked as frequently, 25 points are scored; if it is marked as almost always, 0 points are scored.
|
It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
|
|
Menstrual symptom questionnaire
Tidsramme: It will be done 2 times: before the treatment and 12 weeks after the treatment.
|
The Menstrual Symptom Questionnaire (MSQ) is a 22-item, five-point Likert-type scale developed by Chesney et al. to assess menstrual pain and symptoms.
The Turkish validity and reliability study of the scale was conducted by Güvenç et al. in 2014.
The scale has three sub-dimensions: "Negative Effects/Somatic Complaints", "Menstrual Pain", and "Menstrual Pain Coping Methods".
The results obtained from the internal consistency coefficient, test-retest reliability coefficient, exploratory factor analysis, and criterion-related validity analyses show that the validity and reliability findings of the MSQ in Turkish are at a sufficient level and that it can be used to assess menstrual symptoms in Turkish adolescents.
The MSQ score is calculated by taking the average total score of the items in the scale.
|
It will be done 2 times: before the treatment and 12 weeks after the treatment.
|
|
Menstrual attitude questionnaire
Tidsramme: It will be done 2 times: before the treatment and 12 weeks after the treatment.
|
The Menstrual Attitude Scale (MAS), a Likert-type scale consisting of 33 items and 5 subcategories, was developed by Brooks-Gunn and Ruble (1980).
The Turkish validity and reliability study of the scale was conducted by Kulakaç et al. in 2008.
Due to the difficulty in adapting the original 7-point Likert-type rating form to Turkish, it was converted into a 5-point rating form ranging from 1 to 5 (1.
Strongly disagree, 2. Disagree, 3. Undecided, 4. Agree, 5. Strongly agree) in the Turkish form.
While the original scale consisted of 33 items, two items were removed during the Turkish adaptation due to their low factor loadings.
As a result, the scale consists of 31 items and five sub-dimensions.
Overall, the MAS provides information about how women cope with menstrual situations and their attitudes towards menstruation.
A high average score from the subgroups or the entire scale indicates a "positive" attitude towards menstruation.
|
It will be done 2 times: before the treatment and 12 weeks after the treatment.
|
|
Forced vital capacity (FVC)
Tidsramme: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
|
Pulmonary function was assessed by spirometry in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) standards.
Forced vital capacity (FVC) was measured and recorded.
|
It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
|
|
Forced expiratory volume in 1 second (FEV1)
Tidsramme: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
|
Pulmonary function was assessed by spirometry in accordance with ATS/ERS standards.
Forced expiratory volume in the first second (FEV1) was measured and recorded.
|
It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
|
|
FEV1/FVC ratio
Tidsramme: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
|
Pulmonary function was assessed by spirometry in accordance with ATS/ERS standards.
The ratio of FEV1 to FVC was calculated and recorded.
|
It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
|
|
Peak expiratory flow (PEF)
Tidsramme: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
|
Pulmonary function was assessed by spirometry in accordance with ATS/ERS standards.
Peak expiratory flow (PEF) was measured and recorded.
|
It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Ledende efterforsker: Dilek Çağrı Arslan, Lecturer, Acibadem University
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.
Generelle publikationer
- De Sanctis V, Soliman A, Bernasconi S, Bianchin L, Bona G, Bozzola M, Buzi F, De Sanctis C, Tonini G, Rigon F, Perissinotto E. Primary Dysmenorrhea in Adolescents: Prevalence, Impact and Recent Knowledge. Pediatr Endocrinol Rev. 2015 Dec;13(2):512-20.
- Rakhshaee Z. Effect of three yoga poses (cobra, cat and fish poses) in women with primary dysmenorrhea: a randomized clinical trial. J Pediatr Adolesc Gynecol. 2011 Aug;24(4):192-6. doi: 10.1016/j.jpag.2011.01.059. Epub 2011 Apr 21.
- Yonglitthipagon P, Muansiangsai S, Wongkhumngern W, Donpunha W, Chanavirut R, Siritaratiwat W, Mato L, Eungpinichpong W, Janyacharoen T. Effect of yoga on the menstrual pain, physical fitness, and quality of life of young women with primary dysmenorrhea. J Bodyw Mov Ther. 2017 Oct;21(4):840-846. doi: 10.1016/j.jbmt.2017.01.014. Epub 2017 Feb 7.
- Yang NY, Kim SD. Effects of a Yoga Program on Menstrual Cramps and Menstrual Distress in Undergraduate Students with Primary Dysmenorrhea: A Single-Blind, Randomized Controlled Trial. J Altern Complement Med. 2016 Sep;22(9):732-8. doi: 10.1089/acm.2016.0058. Epub 2016 Jun 17.
- Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096.
- Gutman G, Nunez AT, Fisher M. Dysmenorrhea in adolescents. Curr Probl Pediatr Adolesc Health Care. 2022 May;52(5):101186. doi: 10.1016/j.cppeds.2022.101186. Epub 2022 May 4.
- Unnisa H, Annam P, Gubba NC, Begum A, Thatikonda K. Assessment of quality of life and effect of non-pharmacological management in dysmenorrhea. Ann Med Surg (Lond). 2022 Aug 30;81:104407. doi: 10.1016/j.amsu.2022.104407. eCollection 2022 Sep.
- Kirca N, Celik AS. The effect of yoga on pain level in primary dysmenorrhea. Health Care Women Int. 2023 May;44(5):601-620. doi: 10.1080/07399332.2021.1958818. Epub 2021 Sep 17.
- Gunebakan O, Acar M. The effect of tele-yoga training in healthy women on menstrual symptoms, quality of life, anxiety-depression level, body awareness, and self-esteem during COVID-19 pandemic. Ir J Med Sci. 2023 Feb;192(1):467-479. doi: 10.1007/s11845-022-02985-0. Epub 2022 Mar 24.
- Oksuz S, Unal E. The effect of the clinical pilates exercises on kinesiophobia and other symptoms related to osteoporosis: Randomised controlled trial. Complement Ther Clin Pract. 2017 Feb;26:68-72. doi: 10.1016/j.ctcp.2016.12.001. Epub 2016 Dec 8.
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)
Studiestart
1. december 2025
Primær færdiggørelse (Anslået)
Primær færdiggørelse
1. december 2026
Studieafslutning (Anslået)
Studieafslutning
1. december 2026
Datoer for studieregistrering
Først indsendt
Først indsendt
3. april 2024
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
1. maj 2024
Først opslået (Faktiske)
Først opslået
3. maj 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
27. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. august 2026
Sidst verificeret
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 2024-1/35
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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Individuelle datasæt vil ikke blive delt.
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