Clinical trial NCT04295954: Effect of a Semi-Presence Yoga Program on Primary Dysmenorrhea
Official title: Effect of a Semi-Presence Yoga Program, With Virtual Tutorized Home Tracking, on Dysmenorrhea in University Students: Randomized an Controlled Clinical Trial Protocol.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysmenorrhea Primary
Pain, Menstrual
Yoga
Keywords: clinical trial protocol
exercise therapy
quality of life
exercise movements technique
female
Lead sponsor: University of Huelva
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Pain Intensity
timeFrame: 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;
measure: Changes in Satisfaction and Quality of life
timeFrame: 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 outcomes:
measure: Sleep quality
timeFrame: baseline,1 month, 3 months, 6 months, 12 months
measure: Degree of drowsiness
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months
measure: Anxiety State
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months
measure: Anxiety Traits
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months
measure: Stress
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months
measure: Degree of change
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months
measure: Perceived well-being
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months
measure: Menstrual symptoms
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months
measure: Menstrual Attitude
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Huelva
country: Spain
facility: Ana Abreu Sánchez
state: Andalucía
Study officials:
affiliation: Universidad de Huelva, Facultad de Enfermería
name: Ana Abreu Sánchez, PhD
role: STUDY_DIRECTOR
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