Effect of a Semi-Presence Yoga Program on Primary Dysmenorrhea
NCT ID: NCT04295954
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-10-01
2021-10-01
Brief Summary
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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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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Yoga Intervention
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.
Yoga Intervention
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.
Control group without intervention
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.
No interventions assigned to this group
Interventions
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Yoga Intervention
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
35 Years
FEMALE
No
Sponsors
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University of Huelva
OTHER
Responsible Party
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Ana Abreu Sánchez
Teacher and Researcher
Principal Investigators
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Ana Abreu Sánchez, PhD
Role: STUDY_DIRECTOR
Universidad de Huelva, Facultad de Enfermería
Locations
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Ana Abreu Sánchez
Huelva, Andalusia, Spain
Countries
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References
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Other Identifiers
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DISMYOGA01
Identifier Type: -
Identifier Source: org_study_id