Effect of a Semi-Presence Yoga Program on Primary Dysmenorrhea

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of a blended learning yoga program using virtually tutored home follow-up on pain intensity measured using the VAS scale, quality of life and adherence among nursing students with moderate to severe dysmenorrhea, compared to a control group of students. Half of the women involved will receive a yoga intervention for dysmenorrhea for 12 weeks, while the other half will continue with their conventional treatment during the same period. The results of the evaluations carried out prior, to the month, 3 months, 6 and 12 months of the intervention will be compared.

Detailed Description
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Dysmenorrhea affects between 50% and 90% of women of childbearing age worldwide, the figure is estimated to be 74.8% in Spain. In addition to pain, other menstrual symptoms affect the normality of those with it, and it is found to cause absenteeism at work and school and influence academic performance. Self-medication with painkillers is one of the most used self-care measures by women with dysmenorrhea despite not being the most appropriate. So, in recent decades new lines are being investigated that can help reduce the impact of the problem on women with dysmenorrhea. According to several studies, physical exercise is an effective supportive therapy in dysmenorrhea, and in particular through yoga has been found relief from menstrual symptoms and associated anguish, and improvement in pain and quality of life. The practice of yoga has shown physical, emotional and general well-being improvements. But it is advisable to continue to investigate because of the heterogeneity if the interventions it is difficult to reach consensus as to the time and frequency of the sessions, program duration or type of yoga program and the most appropriate postures. It is therefore recommended to unify the characteristics of the participants, describe the programs in detail, extend the duration of clinical trials, and carry them out with greater methodological rigor. A novel aspect of this specific yoga program for dysmenorrhea is the semi-presence and home virtual tutoring of the intervention that will make it easier for women to practice at home according to their time possibilities or their health status, being guided by experts and supported with validated material for the intervention. Online tutoring and monitoring can promote adherence, compliance with intervention more rigorously, and even use of more advisable self-care measures, as evidenced by previous studies with patients with other health problems. So, the aim of this clinical trial is to analyze the effects of a 12-month Hatha Yoga program based on physical postures, breathing and meditation in a blended learning modality with a virtually tutored home follow-up, on the intensity of pain measured using the VAS and on the quality of life of nursing students with dysmenorrhea in Andalusia. The results will be compared with a control group of students who will continue their usual lifestyle during the same period. They will be evaluated in advance, within a month, 3 months, 6 months and one year after receiving the intervention. The project has been approved by the Andalusian Ethics and Research Committee. The yoga program has been designed according to previous studies for dysmenorrhea and the Guidelines for Developing Yoga Interventions for Randomized Trials. It is a Hatha Yoga Intervention for dysmenorrhea, i.e. body, respiratory and mental work led by teachers with more than 600 hours of accredited training and at least 300 hours of experience with adults with varied chronic health conditions. The program has been triangulated by experts and piloted after. It will be held at the Centre of Physical and Sports Activities of the El Carmen University Campus of the University of Huelva. The intervention consists of three weekly 30-minute yoga sessions for 12 weeks. The first 4 weeks 1 face to face session and 2 home yoga sessions guided by the yoga teacher will be taught weekly in all cases. At home, the participants will also have a video and a diptych of the same yoga series designed for this trial. There will be a virtual platform to project participants by the yoga teacher and researchers. After the first 4 weeks they will continue with 3 weekly sessions of 30 minutes each, of directed home yoga also. All intervention group participants will be invited to participate in online focus groups during week 12 of the clinical trial to explore their experiences and satisfaction with the progress of the study and to implement adaptations, if necessary. Each session consists of physical postures or preparation asanas, and they are a means to reach the central asanas cobra, cat and fish. Followed by asanas of compensation, relaxation and meditation. Our hypothesis is that women who participate in a blended Hatha Yoga program will report an improvement in their intensity of pain and the symptoms associated with dysmenorrhea, quality of life, absenteeism, academic performance, daytime fatigue, stress, wellbeing, among other secondary results in the short, mid and long term

Official Title
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Effect of a Semi-Presence Yoga Program, With Virtual Tutorized Home Tracking, on Dysmenorrhea in University Students: Randomized an Controlled Clinical Trial Protocol.

Conditions
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Dysmenorrhea Primary, Pain, Menstrual, Yoga

Intervention / Treatment
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* Other: Yoga Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Nulliparous women who exhibit moderate-severe pain, 4-10 according to VAS, associated with menstruation in their last cycle, have no history of diagnosed gynecological pathology, and have an internet access device (mobile, computer or table). Exclusion Criteria: • Those who do not meet the criteria for inclusion or do not wish to participated voluntarily, suffer from any other illnesses associated with pain or limiting physical exercise, as well as exclude women who already perform yoga.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups will be formed with women who meet the inclusion criteria. Each participant will be randomly assigned to each group, receiving different treatment depending on the group in which it has been assigned: the intervention group will receive yoga intervention and the control group will continue with its conventional treatment for the dysmenorrhea.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Intervention<br>This group will receive the Yoga Intervention for dysmenorrhea that will consist of 3 yoga sessions a week of 30 minutes each, for 12 weeks. The first 4 weeks 1 of the sessions will be face to face and the other 2 home sessions guided by a vieo and a brochure, and tutored from the virtual platform by the yoga teacher and researchers. This space will also serve for participants to share experiences. After the first 4 weeks, participants will continue with the virtually tutored home yoga program, consisting of 3 weekly sessions of 30 minutes until completing the 12 weeks. They will be protected in all cases by the teacher and researchers. All intervention group participants will be invited to participate in online focus groups during week 12 to explore their experiences and satisfaction with the progress of the study and to implement adaptations, if necessary. They will be evaluated before the start of the yoga program per month, 3 months, 6 months and a year after the intervention. | Other: Yoga Intervention<br>* It is an intervention based on Hatha yoga designed specifically to improve dysmenorrhea. This intervention consists of physical postures, also called asanas; meditation and breathing. It begins with a progression of various asanas until reaching the three central postures: cat, cobra and fish. The compensation asanas of these central postures are then performed, and it is closed with a relaxation. The program and Yoga Intervention have been triangulated by experts and piloted afterwards.<br>|
| No Intervention: Control group without intervention<br>Participants in the comparison group without intervention will not receive yoga intervention, will follow their conventional treatment and their usual daily activities. They will be told not to do yoga. They will be evaluated in advance, per a month, 3 months, 6 months and a year after the intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Pain Intensity | Pain intensity will be assessed with the Visual Analog Pain Scale (VAS): Is a continuous scale consisting of a horizontal line of 10 centimeters (100 mm) in length, ranging painless (score of 0) to pain as severe as it could be or worst imaginable pain (score of 100). | Change from baseline pain intensity at 1 month; Change from baseline pain intensity at 3 months; Change from baseline pain intensity at 6 months; Change from baseline pain intensity at 12 months; | 
| Changes in Satisfaction and Quality of life | Quality of life will be evaluated with the SF-12 Abbreviated Quality of Life Questionnaire, with consists of 12 quality of life items measured o a Likert scale between 0 and 6. Explore multidimensional health and self-administer. | Change from baseline Quality of Life at 1 month; Changes from baseline Quality of Life at 3 months; Changes from baseline Quality of Life at 6 months; Changes from baseline Quality of Life at 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality | Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI). It is a self-report scale that is completed in 5 minutes; it consists of 19 items and contains seven subscales each weighted equally on a scale of 0 to 3, with higher scores indicating a lower sleep quality rating. The total sum ranging from 0 (good sleep quality) to 21 (poor sleep quality) reflects poor sleep if it is ≥ 5. | baseline,1 month, 3 months, 6 months, 12 months | 
| Degree of drowsiness | Degree of drowsiness will be measured with the Epworth Sleepiness Questionnaire (ESE), a self-applicable instrument for assessing the propensity to fall asleep in eight situations. Each is evaluated on a scale of 0-3, where 0 means zero probability of falling asleep and 3 high probability. The sum of the grades results: 0-24. | baseline, 1 month, 3 months, 6 months, 12 months | 
| Anxiety State | Anxiety as a state, will be measured using the STAI Status Scale, Spielberger. Will assesse how an individual feels at a given time. The scale include 20 items using a 4-points Likert scale (20 to 80). Higher scores indicate an increase in anxiety levels. | baseline, 1 month, 3 months, 6 months, 12 months | 
| Anxiety Traits | Anxiety as a trait, will be measured using the STAI Spielberger Trait. Anxiety traits will assesse how an individual feels in general. Include 20 items using a 4-points Likert scale (20 to 80). Higher scores indicate an increase in anxiety levels. | baseline, 1 month, 3 months, 6 months, 12 months | 
| Stress | Stress will be measured with the Perceived Stress Scale (PSS), is a self-reporting instrument that assesses the perceived stress level over the last month, consists of 14 items ith a five points scale response format (0= never, 1= almost never, 2= from time to time, 3= often, 4= very often). The highest score corresponds to a higher level of perceived stress. | baseline, 1 month, 3 months, 6 months, 12 months | 
| Degree of change | The perception of degree of change on the overall state will be measured with the Grade of Change Perception Scale (GAC), with the following gradation Much worse/ worse /a little better / same / a little better/ better until much better. | baseline, 1 month, 3 months, 6 months, 12 months | 
| Perceived well-being | Well-being will be measured by the Spanish version of the Warwick-Edinburgh Mental Welfare Scale (EBMWE). The questionnaire has 14 items, with 5 answer options (from 1 to 5). Higher scores indicate better mental well-being. | baseline, 1 month, 3 months, 6 months, 12 months | 
| Menstrual symptoms | It will be evaluated with 13 closed dichotomous questions, about presence or absence of vomiting, dizziness, headaches, irritability, edema, headaches, constipation, diarrhea, tiredness, anxiety among others. | baseline, 1 month, 3 months, 6 months, 12 months | 
| Menstrual Attitude | It will be evaluated using the MAQ (Brooks-Gunn & Ruble 1980) Menstrual Attitude Questionnaire. The Mentrual Attitude Questionnaire is a useful tool for evaluating menstrual attitudes among high school and college students. It consists of 7 answer options, in which 1 means totally disagree and 7 totally agree. It is self-administered. | baseline, 1 month, 3 months, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical trial protocol, exercise therapy, quality of life, exercise movements technique, female