The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
NCT ID: NCT06398990
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
42 participants
INTERVENTIONAL
2025-12-01
2026-12-31
Brief Summary
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Detailed Description
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G-Power Statistical and Qualitative Data Analysis Software version 3.1.9.2 will be used to estimate the sample size required for the study. Considering that the study consists of a total of three parallel groups (cognitive exercise therapy approach, yoga, control) with measurements taken at three different time points, and given an effect size of Cohen's f = 0.25 and a significance level (α) of 0.05, and power (1-β error level) of 0.80, the total sample size is planned to be 36 cases, with a minimum of 12 cases per group. Considering a potential follow-up loss rate of 20%, it is estimated that at least 42 participants should be included in the study.
In similar studies in the literature, the effect size observed in menstrual pain levels is very large. Considering that the effect size may be more moderate in real life and in order to increase the publishability of the research findings, the effect size was set to Cohen's f = 0.25 and the sample size calculation was performed.
The 1st intervention group will receive cognitive exercise therapy approach, the 2nd intervention group will receive yoga, and the 3rd control group will consist of people receiving routine medical treatment. In order to fully reveal the effectiveness of the applications, reduce bias, and ensure homogeneity between the training and control groups, the distribution of groups will be determined randomly using a computer program.
Yoga and cognitive exercise therapy approach will be applied by a physiotherapist who has training in both fields. Treatments will continue twice a week for 12 weeks. After the initial assessment of the cases, one-to-one, face-to-face trainings will be carried out in the first week (2 sessions) in order to ensure their compliance with the treatment and to fully understand the treatment method. Afterwards, treatments will be carried out synchronously with the patients 2 times a week via the online platform.
Evaluations will be carried out 3 times as pre-treatment, 6th week and 12th week. All evaluations will be made face-to-face in the relevant clinic.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cognitive Exercise Therapy Approach
Cognitive exercise therapy sessions will consist of exercises including various movements in one session and the exercises will be worked with respiratory control, accompanied by a physiotherapist.
Cognitive Exercise Therapy Approach
It will continue twice a week for 12 weeks. After the initial evaluation of the cases, one-on-one, face-to-face training will be provided with the patient in the first week (2 sessions) in order to ensure their compliance with the treatment and to fully understand the treatment method. Then, treatments will be carried out synchronously with the patients twice a week via the online platform (Zoom).
Yoga Programme
Yoga sessions will consist of exercises including various movements in one session and the exercises will be practised with respiratory control, accompanied by a physiotherapist.
Yoga
It will continue twice a week for 12 weeks. After the initial evaluation of the cases, one-on-one, face-to-face training will be provided with the patient in the first week (2 sessions) in order to ensure their compliance with the treatment and to fully understand the treatment method. Then, treatments will be carried out synchronously with the patients twice a week via the online platform (Zoom).
Routine Medical Treatment
Individuals in this group will receive medical treatment recommended by the relevant physician.
Routine Medical Treatment
Assessments of individuals in this group will be made face-to-face in the relevant clinic.
Interventions
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Cognitive Exercise Therapy Approach
It will continue twice a week for 12 weeks. After the initial evaluation of the cases, one-on-one, face-to-face training will be provided with the patient in the first week (2 sessions) in order to ensure their compliance with the treatment and to fully understand the treatment method. Then, treatments will be carried out synchronously with the patients twice a week via the online platform (Zoom).
Yoga
It will continue twice a week for 12 weeks. After the initial evaluation of the cases, one-on-one, face-to-face training will be provided with the patient in the first week (2 sessions) in order to ensure their compliance with the treatment and to fully understand the treatment method. Then, treatments will be carried out synchronously with the patients twice a week via the online platform (Zoom).
Routine Medical Treatment
Assessments of individuals in this group will be made face-to-face in the relevant clinic.
Eligibility Criteria
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Inclusion Criteria
* Having had a menstrual cycle for at least 6-12 months (ACOG, 2018),
* Having menstrual pain intensity of ≥4 cm according to the Visual Analog Scale (VAS, 0-10 cm) (Kannan, P. 2015; Yonglitthipagon, P. 2017),
* To have been diagnosed with primary dysmenorrhea according to the clinical characteristics and diagnostic approach defined in international dysmenorrhea guidelines (ACOG 2018; JOGC 2017),
* Nulliparous (having never given birth),
* Able to read and write in Turkish,
* Willing to participate in the study and having provided informed consent.
Exclusion Criteria
* Presence of serious comorbidities, including neurological, cardiovascular, musculoskeletal, psychiatric, gastrointestinal, or autoimmune disorders,
* History of surgery involving the abdominal, pelvic, or spinal regions within the past 12 months,
* Current pregnancy or suspected pregnancy,
* Use of intrauterine devices (IUDs),
* Current or recent participation in cognitive exercise therapy and/or yoga interventions,
* Concurrent participation in another clinical study.
10 Years
19 Years
FEMALE
No
Sponsors
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Bezmialem Vakif University
OTHER
Acibadem University
OTHER
Responsible Party
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Dilek Cagri
Principal Investigator
Principal Investigators
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Dilek Çağrı Arslan, Lecturer
Role: PRINCIPAL_INVESTIGATOR
Acıbadem Mehmet Ali Aydınlar University
Locations
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Acibadem Mehmet Ali Aydinlar University
Istanbul, Ataşehir, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2024-1/35
Identifier Type: -
Identifier Source: org_study_id
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