NCT06293313

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Inonu University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Dysmenorrhea
• Anxiety
• Anxiety Disorders and Symptoms
• Pain, Menstrual

Interventions

Type	Name	Description
PROCEDURE	Mindfulness training	Before starting the study, an appointment will be made to meet with the students participating in the mindfulness group with randomization on the specified day and time. The students and the researcher will meet in a quiet, calm room of the school. Students will be informed about the practice of mindfulness and their written and verbal consents will be obtained before participating in the study. Then, a pre-test will be applied to the students who agree to participate in the study.
OTHER	Will not be given any application	Before starting the research, the students in the control group determined by the randomization method will be informed about the research. Written and verbal consent will be obtained from the students that the students agree to participate in the research. Afterwards, students will meet in a quiet and calm room of the school on the specified day and time. Before starting the research, students will be given a pre-test. A mid-term test will be performed 8 weeks after the pre-test.

Timeline

• Start date: 2024-02-28
• Primary completion: 2024-04-28
• Completion: 2024-08-28
• First posted: 2024-03-05
• Last updated: 2024-03-05

Locations

1 site across 1 country: Turkey (Türkiye)