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

Acibadem University

Status

Enrolling

Conditions

Dysmenorrhea

Primary Dysmenorrhea

Treatments

Other: Yoga

Other: Routine Medical Treatment

Other: Cognitive Exercise Therapy Approach

Study type

Interventional

Funder types

Other

Identifiers

NCT06398990

2024-1/35

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 estimated patients

Sex

Female

Ages

10 to 19 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

42 participants in 3 patient groups

Cognitive Exercise Therapy Approach

Experimental group

Description:

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.

Treatment:

Other: Cognitive Exercise Therapy Approach

Yoga Programme

Experimental group

Description:

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.

Treatment:

Other: Yoga

Routine Medical Treatment

Other group

Description:

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

Treatment:

Other: Routine Medical Treatment