Clinical trial NCT04910529: The Effect of Yoga Practice on Pain Intensity, Menstruation Symptoms and Quality of Life in Primary Dysmenorrhea
Official title: The Effect of Yoga Practice on Pain Intensity, Menstruation Symptoms and Quality of Life in Nursing Students With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Pain, Menstrual
Quality of Life
Keywords: yoga
menstrual pain
menstrual symptoms
quality of life
nursing students
primary dysmenorrhea
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel, two arm, randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this randomized controlled study is to evaluate the effect of yoga practice on pain intensity, menstruation symptoms and quality of life in nursing students with primary dysmenorrhea. The hypothesis of this study is that yoga reduces pain and menstrual symptom severity and improves quality of life.

Detailed description: In the study, 52 students will be randomly assigned to intervention (yoga) and control groups. The researcher will provide information about the purpose of the study and the study process by interviewing all the students in the sample online. All students participating in the study, who are in the yoga or control group of the study, will be given a data collection form as a pre-test by the researcher.

Hatha yoga will be applied to the students (n = 26) in the yoga group in the study. Considering the studies conducted with these students, it is planned to practice Hatha yoga for 60 minutes twice a week for three menstrual cycles (12 weeks). Yoga practice will be done online by the researcher Aslıhan Aksu (A.A.), who has a Yoga Alliance-approved yoga instructor certificate, on the determined days and times using appropriate platforms. In the control group (n=26), no intervention will be made for 12 weeks. The results will be collected through data collection forms before the yoga practice and after the 12-week yoga practice is completed. The data collection forms applied to all students in the yoga and control groups at the beginning of the study will be applied to the control group again at the end of 12 weeks. The primary expected result of the study is the effect of yoga on students' menstrual pain intensity. The secondary expected results of the study are to determine the effect of yoga on students' menstrual symptoms and quality of life.

Eligibility criteria: Inclusion Criteria:

* Accepting voluntarily to participate in the study.
* Studying in 1st and 2nd grade between 18 October 2021-16 September 2022 at Mersin University Faculty of Nursing in the Academic Year of 2021-2022,
* Between the ages of 18-24 years,
* Willing to participate in the study,
* Having the facilities (computer, internet, etc.) to participate in the online training,
* Having female gender and a regular menstruation period (occurring at intervals of 21-35 days and lasting 3-8 days),
* Having menstrual pain intensity at least 4 points according to the Visual Pain Scale,
* Having a score of 60 or more according to the Menstruation Symptom Scale,
* Not using hormonal contraception and intrauterine equipment,
* Not pregnant and have not experienced pregnancy before,
* Not having a systemic and chronic disease,
* There is no physical health problem that will prevent/limit yoga practice,
* No diagnosed musculoskeletal disease or no severe heart disease,
* Not practicing yoga regularly,
* No diagnosed psychiatric problems,
* Did not take the Obstetrics-Women's Health and Diseases Nursing course,
* Female students with primary dysmenorrhea who signed the Informed Consent Form.

Exclusion Criteria:

* Not accepting voluntarily to participate in the study.
* Studying in Mersin University Nursing Faculty in the 1st and 2nd grade except 18 October 2021-16 September 2022 in the Academic Year of 2021-2022,
* Younger than 18 years old or over 24 years old,
* Not having the facilities (computer, internet, etc.) to participate in the online training,
* Not having female gender and a regular menstruation period,
* Menstrual pain intensity less than 4 points according to the Visual Pain Scale,
* Having a score of 59 or less according to the Menstruation Symptom Scale,
* Using hormonal contraception and intrauterine device,
* Pregnant and have experienced pregnancy before,
* Having a systemic and chronic disease,
* Having a physical health problem that will prevent/limit yoga practice,
* Diagnosed musculoskeletal disease or severe heart disease,
* Doing regular yoga exercises,
* Having a psychiatric problem,
* Obstetrics-Gynecology and Diseases Nursing course,
* Students without primary dysmenorrhea who do not sign the Informed Consent Form.

Primary outcomes:
measure: Pain will evaluate using The The Short Form of the McGill Pain Questionnaire
timeFrame: Change from before implementation and 12th week of practice
Secondary outcomes:
measure: Menstrual symptoms will evaluate using the Menstrual Symptom Questionnaire
timeFrame: Change from before implementation and 12th week of practice.
measure: Quality of life will evaluate using SF-36 Quality of Life Questionnaire
timeFrame: Change from before implementation and 12th week of practice
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
state: Yenisehir
Study officials:
affiliation: Professor
name: Duygu VEFİKULUCAY YILMAZ, PhD
role: STUDY_DIRECTOR
References: