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

NCT06398990 | Recruiting DMC

• 1 other identifier: 2024-1/35
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dysmenorrhea; Primary Dysmenorrhea

Keywords

dysmenorrhea; mind-body exercises; cognitive exercise therapy approach; yoga

Outcome Measures

Primary Outcomes (6)

• 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.

  Pain intensity will be assessed 2 days before, 1 day before, on the 1st, 2nd and 3rd day of menstruation.

• 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).

  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.

  It will be done 3 times: before the treatment, at the 6th week and at the 12th week.

• Physical function (Respiratory Function)

  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)

  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.

• 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.

  It will be done 3 times: before the treatment, at the 6th week and at the 12th week.

Secondary Outcomes (5)

• Education absenteeism

  It will be done twice: before the treatment and at the 12th week after the treatment.

• Depression, anxiety, stress level

  It will be done 3 times: before the treatment and 12 weeks after the treatment.

• Dysmenorrhea Impact

  It will be done 3 times: before the treatment and 12 weeks after the treatment.

• Physical activity

  It will be done 3 times: before the treatment and 12 weeks after the treatment.

• Patient satisfaction

  It will be done twice: before the treatment and at the 12th week after the treatment.

Study Arms (3)

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.

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.

Other: Yoga

Routine Medical Treatment

OTHER

Individuals in this group will receive medical treatment recommended by the relevant physician.

Other: Routine Medical Treatment

Interventions

Cognitive Exercise Therapy Approach OTHER

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).

Cognitive Exercise Therapy Approach

Yoga OTHER

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

Routine Medical Treatment OTHER

Assessments of individuals in this group will be made face-to-face in the relevant clinic.

Routine Medical Treatment

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acibadem University: lead
• Bezmialem Vakif University: collaborator

Study Sites (1)

Acibadem Mehmet Ali Aydinlar University

Istanbul, Ataşehir, 34752, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• 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.

  PMID: 35523674 BACKGROUND

• 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.

  PMID: 36147090 BACKGROUND

• 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.

  PMID: 26841639 BACKGROUND

• 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.

  PMID: 33030880 BACKGROUND

• 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.

  PMID: 29037637 BACKGROUND

• 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.

  PMID: 34534030 BACKGROUND

• 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.

  PMID: 21514190 BACKGROUND

• 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.

  PMID: 27315239 BACKGROUND

• 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.

  PMID: 35332504 BACKGROUND

• 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.

  PMID: 28107853 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Yoga

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Dilek Çağrı Arslan, Lecturer

  Acıbadem Mehmet Ali Aydınlar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Çağrı Arslan, Lecturer

CONTACT

+902165004182; Dilek.Cagri@acibadem.edu.tr

Alis Kostanoğlu, Assoc. Prof.

CONTACT

Akostanoglu@bezmialem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because the study involved mind-body exercise practices such as cognitive exercise therapy approach and yoga, and because participants directly experienced the type of exercise, it was impossible to conceal which group they were in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: May 3, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)