DysmenorrheaNCT06398990
The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
A study testing Cognitive Exercise Therapy Approach, Yoga and Routine Medical Treatment in people with Dysmenorrhea and Primary Dysmenorrhea, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Dysmenorrhoea is a condition that negatively affects the quality of life in women of many age groups. In girls with dysmenorrhoea in adolescence, there is an effect on school performance, self-confidence-depression problems and a decrease in quality of life due to pain. Read more about this study
- Who is it for?
- Ages 10 to 19 years, women only
- Conditions the study is for
- Dysmenorrhea, Primary Dysmenorrhea
- What is being tested?
- Cognitive Exercise Therapy Approach, Yoga and Routine Medical Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to Dec 2026
- Phase
- Interventional
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 10 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between the ages of 10 and 19,
- 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.
Who cannot join
- History or clinical findings suggestive of secondary dysmenorrhea,
- 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),
- Having participated in a regular exercise, sports, or physiotherapy program within the last 6 months,
- Concurrent participation in another clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alis Kostanoğlu, Assoc. Prof. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem Mehmet Ali Aydinlar University
Istanbul, Ataşehir, 34752
Dilek ÇAĞRI ARSLAN, Lecturer, +90539964, Dilek.Cagri@acibadem.edu.tr
About this study
Official title: The Effect of Telerehabilitation-Based Cognitive Exercise Therapy Approach and Yoga on Pain, Physical Function and Quality of Life in Adolescents With Dysmenorrhoea
Dysmenorrhoea is a condition that negatively affects the quality of life in women of many age groups. In girls with dysmenorrhoea in adolescence, there is an effect on school performance, self-confidence-depression problems and a decrease in quality of life due to pain. In order to eliminate these negative effects, they should receive a good treatment. Medical treatment usually tries to minimise and balance this situation. Considering the fact that families do not want to use drugs such as oral contraceptives in their children at this age and the risks of oral contraceptives, parents are in different searches. Considering that the approach to pain should always be from a holistic perspective, yoga and cognitive exercise therapy approaches are both biopsychosocial treatment methods within the scope of mind-body integrity. Yoga and cognitive exercise therapy approach is thought to reduce symptoms, improve physical functions and quality of life in adolescent girls. With these positive effects, school absenteeism decreases, depression and self-confidence improve. Health costs will also be reduced to some extent.
Read the detailed description
This study was designed as a prospective, randomised, controlled, parallel group study.
G-Power Statistical and Qualitative Data Analysis Software 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 45 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
- Dysmenorrhea, Primary Dysmenorrhea
- Being tested
- Cognitive Exercise Therapy Approach, Yoga, Routine Medical Treatment
- Keywords
- dysmenorrhea, mind-body exercises, cognitive exercise therapy approach, yoga
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Exercise Therapy ApproachOther
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).
YogaOther
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 TreatmentOther
Assessments of individuals in this group will be made face-to-face in the relevant clinic.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Exercise Therapy Approach | Experimental | 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. Receives: Other: Cognitive Exercise Therapy Approach |
| Yoga Programme | Experimental | 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. Receives: Other: Yoga |
| Routine Medical Treatment | Other | 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. Receives: Other: Routine Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (VAS)
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.
Measured: Baseline and each menstrual cycle occurring during the 12-week intervention period (approximately three cycles)
Physical function (Flexibility)
Sit-Reach Test: The flexibility of the subjects participating in the study will be evaluated with a standard sit-and-reach box (Sit and Reach Trunk Flexibility Assessment Testing Box, Baseline, NY, USA).
Measured: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
Physical function (Peripheral muscle strength)
Peripheral Muscle Strength: To evaluate the peripheral muscle strength of the subjects, hip flexors, hip extensors and hip abductors will be evaluated with a hand-held dynamometer in both legs.
Measured: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
Physical function (Heart Rate Variability)
Heart Rate Variability: Heart rate variability (HRV) defines the autonomic modulation of heart rate. It reflects parasympathetic activity and sympathetic/parasympathetic nervous system balance. Neuroimaging studies have shown that nociceptive stimulation is closely related to autonomic nervous system activity. Pain can cause a decrease in parasympathetic activity, an increase in sympathetic activity, and sympathovagal imbalance. Autonomic nervous system imbalance caused by sympathetic overactivity may be another cause of primary dysmenorrhea. In response to changes in the external environment, the ANS maintains homeostasis of the internal environment of the human body through the interaction between the sympathetic and parasympathetic nerves. A lack of coordination between the two systems can cause various symptoms. For these reasons, heart rate variability will be measured and recorded in adolescent girls with primary dysmenorrhea using the Polar H10 device.
Measured: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
Adolescent quality of life
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.
Measured: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
Forced vital capacity (FVC)
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.
Measured: 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)
Pulmonary function was assessed by spirometry in accordance with ATS/ERS standards. Forced expiratory volume in the first second (FEV1) was measured and recorded.
Measured: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
FEV1/FVC ratio
Pulmonary function was assessed by spirometry in accordance with ATS/ERS standards. The ratio of FEV1 to FVC was calculated and recorded.
Measured: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
Peak expiratory flow (PEF)
Pulmonary function was assessed by spirometry in accordance with ATS/ERS standards. Peak expiratory flow (PEF) was measured and recorded.
Measured: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
Secondary outcomes (7)
Education absenteeism
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.
Measured: This procedure will be performed 3 times: through study completion, an average of 3 months
Depression, anxiety, stress level
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.
Measured: It will be done 2 times: before the treatment and 12 weeks after the treatment.
Dysmenorrhea Impact
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.
Measured: It will be done 2 times: before the treatment and 12 weeks after the treatment.
Physical activity
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.
Measured: It will be done 2 times: before the treatment and 12 weeks after the treatment.
Patient satisfaction
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.
Measured: This procedure will be performed once: at the 12th week after treatment.
Menstrual symptom questionnaire
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.
Measured: It will be done 2 times: before the treatment and 12 weeks after the treatment.
Menstrual attitude questionnaire
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.
Measured: It will be done 2 times: before the treatment and 12 weeks after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies 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
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University
- Responsible party
- Principal investigator, Dilek Cagri, Acibadem University
- Investigators
- Dilek Çağrı Arslan, Lecturer, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398990
- Sponsor's protocol ID
- 2024-1/35
- Status last verified
- May 2026
- First submitted
- 3 Apr 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the end of the study, the general data results of the participants will be given statistically. Individual data sets will not be shared.
Publications
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.
PubMed 35523674Unnisa 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.
PubMed 36147090De 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.
PubMed 26841639Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096.
PubMed 33030880Yonglitthipagon 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.
PubMed 29037637Kirca 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.
PubMed 34534030Rakhshaee 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.
PubMed 21514190Yang 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.
PubMed 27315239Gunebakan 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.
PubMed 35332504Oksuz 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.
PubMed 28107853