Dysmenorrhea PrimaryNCT04295954
Effect of a Semi-Presence Yoga Program on Primary Dysmenorrhea
A study testing Yoga Intervention in people with Dysmenorrhea Primary and Pain, Menstrual, run by University of Huelva at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Dysmenorrhea Primary, Pain, Menstrual, Yoga
- What is being tested?
- Yoga Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Conditions
- Dysmenorrhea Primary, Pain, Menstrual, Yoga
- Being tested
- Yoga Intervention
- Keywords
- clinical trial protocol, exercise therapy, quality of life, exercise movements technique, female
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Intervention | Experimental | 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. Receives: Other: Yoga Intervention |
| Control group without intervention | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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 (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 1 month, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Oct 2020
- Primary completion1 Nov 2020
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Huelva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Abreu Sánchez, University of Huelva
- Investigators
- Ana Abreu Sánchez, PhD, Study director, Universidad de Huelva, Facultad de Enfermería
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295954
- Sponsor's protocol ID
- DISMYOGA01
- Status last verified
- Dec 2020
- First submitted
- 26 Feb 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26346058Fernandez-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.
PubMed 30096156McGovern 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.
PubMed 29902363Fernandez-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.
PubMed 30818861Armour 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.
PubMed 30654775Armour 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.
PubMed 31538328Ross 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.
PubMed 20105062Cramer 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.
PubMed 29697885McCall 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.
PubMed 23762174Dodich 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.
PubMed 30485713Kim 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.
PubMed 31383452Yonglitthipagon 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.
PubMed 29037637Armour 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.
PubMed 31339951Collins 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.
PubMed 9272792Sherman 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.
PubMed 23082079
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04295954
- Acronym / sponsor ID
- DISMYOGA01
- Conditions
- Dysmenorrhea Primary, Pain, Menstrual, Yoga
- Keywords
- clinical trial protocol, exercise therapy, quality of life, exercise movements technique, female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of HuelvaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Yoga Intervention | Experimental | Other: Yoga InterventionThis 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. |
| Control group without intervention | No 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga InterventionIt 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. | Other | Yoga Intervention |
Primary outcome
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).
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.
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.
9 secondary outcomes
Sleep quality
Time frame: baseline,1 month, 3 months, 6 months, 12 months
Degree of drowsiness
Time frame: baseline, 1 month, 3 months, 6 months, 12 months
Anxiety State
Time frame: baseline, 1 month, 3 months, 6 months, 12 months
Anxiety Traits
Time frame: baseline, 1 month, 3 months, 6 months, 12 months
Stress
Time frame: baseline, 1 month, 3 months, 6 months, 12 months
Degree of change
Time frame: baseline, 1 month, 3 months, 6 months, 12 months
Perceived well-being
Time frame: baseline, 1 month, 3 months, 6 months, 12 months
Menstrual symptoms
Time frame: baseline, 1 month, 3 months, 6 months, 12 months
Menstrual Attitude
Time frame: baseline, 1 month, 3 months, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Background: PubMed 26346058Iacovides 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.
- Background: PubMed 30096156Fernandez-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.
- Background: PubMed 29902363McGovern 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.
- Background: PubMed 30818861Fernandez-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.
- Background: PubMed 30654775Armour 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.
- Background: PubMed 31538328Armour 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.
- Background: PubMed 20105062Ross 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.
- Background: PubMed 29697885Cramer 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.
- Background: PubMed 23762174McCall 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.
- Background: PubMed 30485713Dodich 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.
- Background: PubMed 31383452Kim 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.
- Background: PubMed 29037637Yonglitthipagon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Abreu Sánchez, PhD study director
Universidad de Huelva, Facultad de Enfermería
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Intervention in people with Dysmenorrhea Primary and Pain, Menstrual, run by University of Huelva at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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;). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04295954, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.