- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04295954
Effect of a Semi-Presence Yoga Program on Primary Dysmenorrhea
Effect of a Semi-Presence Yoga Program, With Virtual Tutorized Home Tracking, on Dysmenorrhea in University Students: Randomized an Controlled Clinical Trial Protocol.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Andalucía
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Huelva, Andalucía, Spain, 21001
- Ana Abreu Sánchez
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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.
|
No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Pain Intensity
Time Frame: 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;
|
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).
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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;
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Changes in Satisfaction and Quality of life
Time Frame: 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.
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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.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep quality
Time Frame: baseline,1 month, 3 months, 6 months, 12 months
|
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.
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baseline,1 month, 3 months, 6 months, 12 months
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Degree of drowsiness
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months
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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.
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baseline, 1 month, 3 months, 6 months, 12 months
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Anxiety State
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months
|
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.
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baseline, 1 month, 3 months, 6 months, 12 months
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Anxiety Traits
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months
|
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.
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baseline, 1 month, 3 months, 6 months, 12 months
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Stress
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months
|
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
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months
|
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".
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baseline, 1 month, 3 months, 6 months, 12 months
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Perceived well-being
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months
|
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
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Menstrual symptoms
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months
|
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.
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baseline, 1 month, 3 months, 6 months, 12 months
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Menstrual Attitude
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months
|
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.
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baseline, 1 month, 3 months, 6 months, 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ana Abreu Sánchez, PhD, Universidad de Huelva, Facultad de Enfermería
Publications and helpful links
General Publications
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
- Collins SL, Moore RA, McQuay HJ. The visual analogue pain intensity scale: what is moderate pain in millimetres? Pain. 1997 Aug;72(1-2):95-7. doi: 10.1016/s0304-3959(97)00005-5.
- Ross A, Thomas S. The health benefits of yoga and exercise: a review of comparison studies. J Altern Complement Med. 2010 Jan;16(1):3-12. doi: 10.1089/acm.2009.0044.
- Iacovides S, Avidon I, Baker FC. What we know about primary dysmenorrhea today: a critical review. Hum Reprod Update. 2015 Nov-Dec;21(6):762-78. doi: 10.1093/humupd/dmv039. Epub 2015 Sep 7.
- Fernandez-Martinez E, Onieva-Zafra MD, Parra-Fernandez ML. Lifestyle and prevalence of dysmenorrhea among Spanish female university students. PLoS One. 2018 Aug 10;13(8):e0201894. doi: 10.1371/journal.pone.0201894. eCollection 2018.
- McGovern CE, Cheung C. Yoga and Quality of Life in Women with Primary Dysmenorrhea: A Systematic Review. J Midwifery Womens Health. 2018 Jul;63(4):470-482. doi: 10.1111/jmwh.12729. Epub 2018 Jun 14.
- Fernandez-Martinez E, Onieva-Zafra MD, Parra-Fernandez ML. The Impact of Dysmenorrhea on Quality of Life Among Spanish Female University Students. Int J Environ Res Public Health. 2019 Feb 27;16(5):713. doi: 10.3390/ijerph16050713.
- Armour M, Smith CA, Steel KA, Macmillan F. The effectiveness of self-care and lifestyle interventions in primary dysmenorrhea: a systematic review and meta-analysis. BMC Complement Altern Med. 2019 Jan 17;19(1):22. doi: 10.1186/s12906-019-2433-8.
- Armour M, Ee CC, Naidoo D, Ayati Z, Chalmers KJ, Steel KA, de Manincor MJ, Delshad E. Exercise for dysmenorrhoea. Cochrane Database Syst Rev. 2019 Sep 20;9(9):CD004142. doi: 10.1002/14651858.CD004142.pub4.
- Cramer H, Lauche R, Anheyer D, Pilkington K, de Manincor M, Dobos G, Ward L. Yoga for anxiety: A systematic review and meta-analysis of randomized controlled trials. Depress Anxiety. 2018 Sep;35(9):830-843. doi: 10.1002/da.22762. Epub 2018 Apr 26.
- McCall MC, Ward A, Roberts NW, Heneghan C. Overview of systematic reviews: yoga as a therapeutic intervention for adults with acute and chronic health conditions. Evid Based Complement Alternat Med. 2013;2013:945895. doi: 10.1155/2013/945895. Epub 2013 May 16.
- Dodich A, Zollo M, Crespi C, Cappa SF, Laureiro Martinez D, Falini A, Canessa N. Short-term Sahaja Yoga meditation training modulates brain structure and spontaneous activity in the executive control network. Brain Behav. 2019 Jan;9(1):e01159. doi: 10.1002/brb3.1159. Epub 2018 Nov 28.
- Kim SD. Yoga for menstrual pain in primary dysmenorrhea: A meta-analysis of randomized controlled trials. Complement Ther Clin Pract. 2019 Aug;36:94-99. doi: 10.1016/j.ctcp.2019.06.006. Epub 2019 Jun 25.
- Yonglitthipagon P, Muansiangsai S, Wongkhumngern W, Donpunha W, Chanavirut R, Siritaratiwat W, Mato L, Eungpinichpong W, Janyacharoen T. Effect of yoga on the menstrual pain, physical fitness, and quality of life of young women with primary dysmenorrhea. J Bodyw Mov Ther. 2017 Oct;21(4):840-846. doi: 10.1016/j.jbmt.2017.01.014. Epub 2017 Feb 7.
- Armour M, Parry K, Al-Dabbas MA, Curry C, Holmes K, MacMillan F, Ferfolja T, Smith CA. Self-care strategies and sources of knowledge on menstruation in 12,526 young women with dysmenorrhea: A systematic review and meta-analysis. PLoS One. 2019 Jul 24;14(7):e0220103. doi: 10.1371/journal.pone.0220103. eCollection 2019.
- Sherman KJ. Guidelines for developing yoga interventions for randomized trials. Evid Based Complement Alternat Med. 2012;2012:143271. doi: 10.1155/2012/143271. Epub 2012 Oct 2.
- Jeter PE, Slutsky J, Singh N, Khalsa SB. Yoga as a Therapeutic Intervention: A Bibliometric Analysis of Published Research Studies from 1967 to 2013. J Altern Complement Med. 2015 Oct;21(10):586-92. doi: 10.1089/acm.2015.0057. Epub 2015 Jul 21.
- Ferrer M, Vilagut G, Monasterio C, Montserrat JM, Mayos M, Alonso J. [Measurement of the perceived impact of sleep problems: the Spanish version of the functional outcomes sleep questionnaire and the Epworth sleepiness scale]. Med Clin (Barc). 1999 Sep 11;113(7):250-5. Spanish.
- Lopez MA, Gabilondo A, Codony M, Garcia-Forero C, Vilagut G, Castellvi P, Ferrer M, Alonso J. Adaptation into Spanish of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) and preliminary validation in a student sample. Qual Life Res. 2013 Jun;22(5):1099-104. doi: 10.1007/s11136-012-0238-z. Epub 2012 Jul 27.
- Castellvi P, Forero CG, Codony M, Vilagut G, Brugulat P, Medina A, Gabilondo A, Mompart A, Colom J, Tresserras R, Ferrer M, Stewart-Brown S, Alonso J. The Spanish version of the Warwick-Edinburgh mental well-being scale (WEMWBS) is valid for use in the general population. Qual Life Res. 2014 Apr;23(3):857-68. doi: 10.1007/s11136-013-0513-7. Epub 2013 Sep 5.
- Cramer H, Ward L, Saper R, Fishbein D, Dobos G, Lauche R. The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Am J Epidemiol. 2015 Aug 15;182(4):281-93. doi: 10.1093/aje/kwv071. Epub 2015 Jun 26.
- Matthewman G, Lee A, Kaur JG, Daley AJ. Physical activity for primary dysmenorrhea: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2018 Sep;219(3):255.e1-255.e20. doi: 10.1016/j.ajog.2018.04.001. Epub 2018 Apr 7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DISMYOGA01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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