The Effect of Yoga Practice on Pain Intensity, Menstruation Symptoms and Quality of Life in Primary Dysmenorrhea

NCT04910529 | Completed DMC

• 1 other identifier: MersinUni
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea; Pain, Menstrual; Quality of Life

Keywords

yoga; menstrual pain; menstrual symptoms; quality of life; nursing students; primary dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• Pain will evaluate using The The Short Form of the McGill Pain Questionnaire

  The main component of the The Short Form of the McGill Pain Questionnaire (SF-MPQ) consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none, 1=mild, 2=moderate or 3=severe. In this section, sensory (0-33 points), affective (0-12 points) and total (0-45 points) pain quality scores are obtained. The increase in the total pain scores indicates an increase in the perception of pain. The SF-MPQ also includes the Present Pain Intensity (PPI) Index of the Standard MPQ and a Visual Analogue Scale (VAS).

  Change from before implementation and 12th week of practice

Secondary Outcomes (2)

• Menstrual symptoms will evaluate using the Menstrual Symptom Questionnaire

  Change from before implementation and 12th week of practice.

• Quality of life will evaluate using SF-36 Quality of Life Questionnaire

  Change from before implementation and 12th week of practice

Study Arms (2)

Yoga group

EXPERIMENTAL

Hatha yoga, which is one of the most basic yoga methods, will be applied to the students in the study. During each practice within the scope of Hatha yoga, students; breathing exercises, relaxation techniques and warm-up exercises will be applied respectively. In addition to these, asanas (yoga postures) with balance, stretching, relaxation and strengthening components will be applied to the students. This application includes the most basic yoga exercises and does not pose any health risks for practitioners. During the yoga practice in the online environment, the cameras of the students in the yoga group will be turned on and the researcher who has the application will be able to see each student. Yoga will be applied to this group twice a week for 60 minutes each for three menstrual cycles (12 weeks).

Other: Yoga

Control group

NO INTERVENTION

No intervention will be made to the control group, only the data will be collected at the same time as the study group.

Interventions

Yoga OTHER

Hatha yoga, which is one of the most basic yoga methods, will be applied to the students in the study. During each practice within the scope of Hatha yoga, students; breathing exercises, relaxation techniques and warm-up exercises will be applied respectively. In addition to these, asanas (yoga postures) with balance, stretching, relaxation and strengthening components will be applied to the students.

Yoga group

Eligibility Criteria

• Age: 18 Years - 24 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, Yenisehir, 33343, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Yoga

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Duygu VEFİKULUCAY YILMAZ, PhD

  Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and the researcher who carried out the application Aslıhan Aksu (A.A.) cannot be blinded due to the nature of the study. When the study is completed, the control and experimental groups will be coded as A and B and the data will be transferred to the computer environment by an independent researcher. The data coded as A and B will be analyzed by a statistician and the findings will be reported.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Prospective, parallel, two arm, randomized controlled clinical trial

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 2, 2021
• Study Start: May 20, 2021
• Primary Completion: November 20, 2021
• Study Completion: February 20, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)