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

Dysmenorrhea Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06398990
• Other study ID #: 2024-1/35
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Acibadem University
• Contact: Dilek Çagri Arslan, Res. Asst.
• Phone: +902165004182
• Email: Dilek.Cagri[@]acibadem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

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

The population of the study consisted of patients who applied to gynaecology and obstetrics specialists in Istanbul.

G-Power Statistical and Qualitative Data Analysis Software version 3.1.9.2 was used to estimate the sample size required for the study. Considering that the study consisted of a total of three parallel groups to be measured at three different time points and the effect size f=0.25, α error level 0.05, power (1-β error level) 0.80, the total sample size was calculated as 36. When the estimated rate of subjects who might be lost to follow-up was taken as 20%, it was calculated that at least 45 subjects should be included in the study.

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 demonstrate the effectiveness of the interventions, to reduce bias and to ensure homogeneity between the training and control groups, the allocation to the groups will be determined in the randomiser org. programme.

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 (Zoom).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 19 Years

Eligibility

Inclusion Criteria:

• Being diagnosed with dysmenorrhea by a gynecologist and obstetrician,

• Being between the ages of 10-19,

• Being able to read and write Turkish,

• Volunteering to participate in the study.

Exclusion Criteria:

• Being diagnosed with secondary dysmenorrhea,

• Being diagnosed with another gynecological disease,

• Having serious comorbidities (neurological and/or cardiovascular and/or musculoskeletal disorders, psychiatric, gastrointestinal, autoimmune),

• Has a history of surgery involving the abdominal region, pelvic region and spine within the last year,

• Previous experience with yoga and cognitive exercise therapy approaches,

• People who are actively participating in a different study will not be included in the study.

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

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).
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Acibadem University	Bezmialem Vakif University

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	Physical function (Respiratory muscle strength)	Respiratory Muscle Strength: Respiratory muscle strength will be measured according to American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria using an electronic intraoral pressure measurement device (MicroRPM, Micro Medical, England).; Maximal inspiratory pressure (MIP) and Maximal Expiratory Pressure (MEP) measurements of the cases will be made.	It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
Primary	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	School performances	Adolescent cases with dysmenorrhea are usually of school age and cannot attend school for a few days due to the dysmenorrhea they experience during their menstrual periods, and this affects their school performance. For this reason, the school performance of the subjects who will participate in the study will be evaluated with the course notes taken from their parents. Notes taken before and after treatment will be compared.	It will be done twice: before the treatment and at the 12th week after the treatment.
Secondary	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. A low score indicates a good psychological state.	It will be done 3 times: before the treatment and 12 weeks after the treatment.
Secondary	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. As the scores obtained from the scale without reverse items increase, the level of functional and emotional impact of individuals from dysmenorrhea also increases.	It will be done 3 times: before the treatment and 12 weeks after the treatment.
Secondary	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, was first developed by Crocker et al. (1987). Later, a modified form for adolescents was published by Kowalski et al. (1997). The Turkish validity and reliability study of the scale was conducted by Polat in 2017. 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.
Secondary	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.	It will be done twice: before the treatment and at the 12th week after the treatment.