Clinical trial NCT06293313: The Effect of Mindfulness Practice on Coping With Primary Dysmenorrhea on Pain and Anxiety Level
Official title: The Effect of Mindfulness Practice on Coping With Primary Dysmenorrhea on Pain and Anxiety Level
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysmenorrhea
Anxiety
Anxiety Disorders and Symptoms
Pain, Menstrual
Keywords: mindfulness
pain
anxiety
dysmenorrhea
nursing
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of two groups, a control group and a experimental group wo mindfulness group
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS Pain Scale
timeFrame: five month
Secondary outcomes:
measure: State and Trait Anxiety Scale
timeFrame: five month
Other outcomes:
Locations:
city: Bartın
country: Turkey
facility: Bartin University
Study officials:
affiliation: Bartın Unıversity
name: Simge Öztürk, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: