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

NCT06293313 | Recruiting

• 1 other identifier: Inonu-SBF-SO-03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

mindfulness; pain; anxiety; dysmenorrhea; nursing

Outcome Measures

Primary Outcomes (1)

• VAS Pain Scale

  The scale consists of a horizontal line of 100 mm in length. At the left end of the line is the phrase "No pain" or "The pain is completely gone", while at the right end is the phrase "Unbearable pain" or "No reduction in pain at all". The patient is instructed to mark a point on the line that will accurately reflect his or her own pain. The distance of the patient's sign to the left end is measured. This distance, usually measured in millimeters, is reported as "points".

  five month

Secondary Outcomes (1)

• State and Trait Anxiety Scale

  five month

Study Arms (2)

Mindfulness group

EXPERIMENTAL

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

Procedure: Mindfulness training

Control Group

SHAM COMPARATOR

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.

Other: Will not be given any application

Interventions

Mindfulness training PROCEDURE

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.

Mindfulness group

Will not be given any application OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female students who are 18 years of age or older studying at the university will be included.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Bartin University

Bartın, 74001, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dysmenorrhea; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Officials

• Simge Öztürk, Ph.D

  Bartın Unıversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simge ÖZTÜRK, Ph.D

CONTACT

05398751788; sozturk@bartin.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The determination of which university would be included in the control and experimental groups in the research was made through a randomization method. The selection was done blindly by an independent academician unrelated to the research. As a result of the randomization, the control group and the experimental groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A total of two groups, a control group and a experimental group wo mindfulness group

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 5, 2024
• Study Start: February 28, 2024
• Primary Completion: April 28, 2024
• Study Completion: August 28, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)