Clinical trial NCT06398990: The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysmenorrhea
Primary Dysmenorrhea
Lead sponsor: Acibadem University
Sponsor class: OTHER
Collaborators: name: Bezmialem Vakif University
First posted: 2024-05-03
Enrollment: 45
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity (VAS)
timeFrame: Pain intensity will be assessed 2 days before, 1 day before, on the 1st, 2nd and 3rd day of menstruation.
measure: Physical function (Flexibility)
timeFrame: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
measure: Physical function (Peripheral muscle strength)
timeFrame: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
measure: Physical function (Respiratory muscle strength)
timeFrame: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
measure: Adolescent quality of life
timeFrame: It will be done 3 times: before the treatment, at the 6th week and at the 12th week.
Secondary outcomes:
measure: School performances
timeFrame: It will be done twice: before the treatment and at the 12th week after the treatment.
measure: Depression, anxiety, stress level
timeFrame: It will be done 3 times: before the treatment and 12 weeks after the treatment.
measure: Dysmenorrhea Impact
timeFrame: It will be done 3 times: before the treatment and 12 weeks after the treatment.
measure: Physical activity
timeFrame: It will be done 3 times: before the treatment and 12 weeks after the treatment.
measure: Patient satisfaction
timeFrame: It will be done twice: before the treatment and at the 12th week after the treatment.
Other outcomes:
Locations:
Study officials:
affiliation: Acıbadem Mehmet Ali Aydınlar University
name: Dilek Çağrı Arslan, Res. Asst.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.
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.
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.
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.
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.
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.