Yoga Clinical Trial
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.
Verified date | December 2020 |
Source | University of Huelva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 50 |
Est. completion date | October 1, 2021 |
Est. primary completion date | November 1, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Ana Abreu Sánchez | Huelva | Andalucía |
Lead Sponsor | Collaborator |
---|---|
University of Huelva |
Spain,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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; | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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