The Effect of Mindfulness Practice on Coping With Primary Dysmenorrhea on Pain and Anxiety Level

Inonu University

Status: Enrolling

Conditions: Anxiety Disorders and Symptoms; Dysmenorrhea; Pain, Menstrual; Anxiety

Treatments: Procedure: Mindfulness training; Other: Will not be given any application

Study type: Interventional

Funder types: Other

Identifiers

NCT06293313

Inonu-SBF-SO-03

Details and patient eligibility

About

The aim of this project is to determine the effect of mindfulness practice to cope with dysmenorrhea on pain and anxiety levels. The project will be carried out in a semi-randomized controlled manner. It will be applied to 100 students with dysmenorrhea (100 students by increasing by 10%, taking into account the losses that may occur in the 90 students determined in the sample calculation). Students who meet the inclusion criteria and approve of participating in the project will be given a pre-test before the application. 'Introductory Information Form', 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the pre-test. After the pre-test, mindfulness practice will be applied for 8 weeks (1 day/120 minutes per week). At the end of 8 weeks, an intermediate test will be performed in the first 3 days of the first menstrual cycle. After the mid-term test, students will practice mindfulness on their own with the brochures provided. Motivational messages will be sent to students for mindfulness practice, starting 3 days before their cycle. The final test will be administered 3 months after the intermediate test. 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the mid-test and post-test.

Full description

Dysmenorrhea is a gynecological condition that negatively affects the lives of more than half of women during menstruation. The severity of dysmenorrhea can be mild, moderate or high. Dysmenorrhea negatively affects women's social relations, daily lives, business lives, academic achievements and quality of life. Pharmacological and non-pharmacological treatments are used in its treatment. Among the non-pharmacological methods used in the treatment of dysmenorrhea, methods such as aromatherapy, yoga, massage, regular exercise, acupuncture, acupressure, TENS and cognitive behavioral therapy have been used. Mindfulness, one of the cognitive behavioral treatment methods, reduces stress, anxiety and depression in women. The aim of this project is to determine the effect of mindfulness practice to cope with dysmenorrhea on pain and anxiety levels. The project will be carried out in a semi-randomized controlled manner. It will be applied to 100 students with dysmenorrhea (100 students by increasing by 10%, taking into account the losses that may occur in the 90 students determined in the sample calculation). Students who meet the inclusion criteria and approve of participating in the project will be given a pre-test before the application. 'Introductory Information Form', 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the pre-test. After the pre-test, mindfulness practice will be applied for 8 weeks (1 day/120 minutes per week). At the end of 8 weeks, an intermediate test will be performed in the first 3 days of the first menstrual cycle. After the mid-term test, students will practice mindfulness on their own with the brochures provided. Motivational messages will be sent to students for mindfulness practice, starting 3 days before their cycle. The final test will be administered 3 months after the intermediate test. 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the mid-test and post-test.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Being over 18 years old,
• Being literate,
• Having dysmenorrhea,
• Volunteering to participate in the study,
• Participating in mindfulness practice for 8 weeks,
• Not using any pharmacological or non-pharmacological methods,
• Studying at Bartin University

Exclusion criteria

• Not being a university student
• Not experiencing dysmenorrhea
• Not attending at least two mindfulness practices

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Mindfulness group

Experimental group

Description:

Students who agree to participate in the research will be met with students in a quiet room of the school by making an appointment. Individuals will be pre-tested. Mindfulness will be applied within the first 3 days of the menstrual period. After continuing the training for 8 weeks, an interim test will be applied. After 3 months, the final test will be applied

Treatment:

Procedure: Mindfulness training

Control Group

Sham Comparator group

Description:

Students in the control group will not be given any application. A pre-test will be administered before starting the study, an interim test will be applied 8 weeks after the pre-test, and a post-test will be applied 3 months after the interim test. After the study is over, mindfulness will be applied to the students in the control group.

Treatment:

Other: Will not be given any application