The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea

June 3, 2026 updated by: Dilek Cagri, Acibadem University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study was designed as a prospective, randomised, controlled, parallel group study.

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.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Ataşehir
      • Istanbul, Ataşehir, Turkey (Türkiye), 34752
        • Recruiting
        • Acibadem Mehmet Ali Aydinlar University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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),
  • Current or recent participation in cognitive exercise therapy and/or yoga interventions,
  • Concurrent participation in another clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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).
Experimental: 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.
Other: 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).
Other: Routine Medical Treatment
Individuals in this group will receive medical treatment recommended by the relevant physician.
Other: Routine Medical Treatment
Assessments of individuals in this group will be made face-to-face in the relevant clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity (VAS)
Time Frame: Pain intensity will be assessed 2 days before, 1 day before, on the 1st, 2nd and 3rd day of menstruation.
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.
Pain intensity will be assessed 2 days before, 1 day before, on the 1st, 2nd and 3rd day of menstruation.
Physical function (Flexibility)
Time Frame: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
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).
It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
Physical function (Peripheral muscle strength)
Time Frame: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
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.
It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
Adolescent quality of life
Time Frame: 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.
Physical function (Respiratory Function)
Time Frame: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
Respiratory Function: Pulmonary function tests are easy and reliable for evaluating and monitoring the effects of treatment on respiratory function. Spirometry is commonly used to assess respiratory function for this purpose. Measurements will be performed in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) standards. FVC, FEV1, FEV1/FVC, and peak expiratory flow (PEF) parameters will be measured and recorded.
It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
Physical function (Heart Rate Variability)
Time Frame: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
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.
It will be done 3 times: before the treatment, at the 6th week and at the 12th week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: It will be done twice: before the treatment and at the 12th week after the 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.
It will be done twice: before the treatment and at the 12th week after the treatment.
Depression, anxiety, stress level
Time Frame: It will be done 3 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 3 times: before the treatment and 12 weeks after the treatment.
Dysmenorrhea Impact
Time Frame: It will be done 3 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 3 times: before the treatment and 12 weeks after the treatment.
Physical activity
Time Frame: It will be done 3 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 3 times: before the treatment and 12 weeks after the treatment.
Education absenteeism
Time Frame: It will be done twice: before the treatment and at the 12th week after the treatment.
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.
It will be done twice: before the treatment and at the 12th week after the treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Collaborators

Bezmialem Vakif University

Investigators

  • Principal Investigator: Dilek Çağrı Arslan, Lecturer, Acıbadem Mehmet Ali Aydınlar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-1/35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

At the end of the study, the general data results of the participants will be given statistically. Individual data sets will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Dysmenorrhea

Clinical Trials on Cognitive Exercise Therapy Approach

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe