Primary Dysmenorrhea Clinical Trial
Official title:
Heart Rate Variability as an Indicator Associated With the Improvement of Dysmenorrhea After the Warm-water Footbath
Verified date | August 2019 |
Source | Camillians Saint Mary's Hospital Luodong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The effect of warm-water footbath in improving primary dysmenorrhea (PD) was rarely
investigated previously. We aimed to exam the hypothesis that warm-water footbath is
effective to reduce the pain of PD, and the effect is associated with changes in the
autonomic nervous system (ANS) activity.
The quasi-experimental study was carried out enrolling 68 college students) with PD. The
enrolled participants were randomized into two groups and received interventions (footbath
(n=35) versus sitting only (n=33)) for 20 minutes per day on their menstruation days 1 and 2.
After the interventions, we analyzed the association among intervention (with footbath versus
without footbath), heart rate variability (HRV) changes and changes of pain scales (Pain
Visual Analog Scale and short-form McGill Pain Questionnaire).
Status | Completed |
Enrollment | 68 |
Est. completion date | June 30, 2014 |
Est. primary completion date | June 30, 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 20 Years |
Eligibility |
Inclusion criteria: 1. healthy female students aged 16-20 years of the nursing college; 2. had regular menstrual cycles; 3. experienced dysmenorrhea within 6 months before the enrollment; 4. had dysmenorrhea with severity higher than five scores of the pain visual analog scale (PVAS); and 5. had no experience of pregnancy. Exclusion criteria: 1. had irregular menstrual cycles; 2. had circulation problem of legs such as peripheral arterial occlusive disease or deep vein thrombosis; 3. had wounds or skin lesions over legs; and 4. had taken any medications which affect ANS activity. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Camillians Saint Mary's Hospital Luodong |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain visual analog scale, pre-test | Pain visual analog scale was fulfilled as pain assessment before the intervention of menstruation day 1. The pain visual analog scale uses the 10 cm horizontal scale with verbal descriptors, the pain intensity could be graded from "no pain" (score of 0)" to "worst imaginable pain" (score of 10). | Before the intervention of menstruation day 1 | |
Primary | Pain visual analog scale, post-test | Pain visual analog scale was fulfilled as pain assessment after the intervention of menstruation day 2. The pain visual analog scale uses the 10 cm horizontal scale with verbal descriptors, the pain intensity could be graded from "no pain" (score of 0)" to "worst imaginable pain" (score of 10). | After the intervention of menstruation day 2 | |
Primary | Short-Form McGill Pain Questionnaire, pre-test | Short-Form McGill Pain Questionnaire was fulfilled as pain assessment before the intervention of menstruation day 1. It consists of 15 descriptors including 11 descriptors in the sensory subscale and four descriptors in the affective subscale. The pain intensity is scored from "none" (score 0) to "severe" (score 3) for each descriptor, summing the total pain rate index score of 0-45. | Before the intervention of menstruation day 1 | |
Primary | Short-Form McGill Pain Questionnaire, post-test | Short-Form McGill Pain Questionnaire was fulfilled as pain assessment after the intervention of menstruation day 2. It consists of 15 descriptors including 11 descriptors in the sensory subscale and four descriptors in the affective subscale. The pain intensity is scored from "none" (score 0) to "severe" (score 3) for each descriptor, summing the total pain rate index score of 0-45. | After the intervention of menstruation day 2 | |
Primary | Heart rate variability, pre-test of day 1 | Heart rate variability was measured before the interventions on day 1 to assess autonomic nervous function for all participants. Under a sampling rate of 512 Hz, signals from a lead I electrocardiogram were documented by an 8-bit analog-to-digital converter. Fast Fourier transformation was utilized to perform power spectral analysis, which quantified the power spectrum into the standard frequency-domain measurements, including LF (0.04-0.15 Hz), HF (0.15-0.40 Hz) and LF/HF ratio. | Before the interventions on day 1 | |
Primary | Heart rate variability, post-test of day 1 | Heart rate variability was measured after the interventions on day 1 to assess autonomic nervous function for all participants. Under a sampling rate of 512 Hz, signals from a lead I electrocardiogram were documented by an 8-bit analog-to-digital converter. Fast Fourier transformation was utilized to perform power spectral analysis, which quantified the power spectrum into the standard frequency-domain measurements, including LF (0.04-0.15 Hz), HF (0.15-0.40 Hz) and LF/HF ratio. | After the interventions on day 1 | |
Primary | Heart rate variability, pre-test of day 2 | Heart rate variability was measured before the interventions on day 2 to assess autonomic nervous function for all participants. Under a sampling rate of 512 Hz, signals from a lead I electrocardiogram were documented by an 8-bit analog-to-digital converter. Fast Fourier transformation was utilized to perform power spectral analysis, which quantified the power spectrum into the standard frequency-domain measurements, including LF (0.04-0.15 Hz), HF (0.15-0.40 Hz) and LF/HF ratio. | Before the interventions on day 2 | |
Primary | Heart rate variability, post-test of day 2 | Heart rate variability was measured after the interventions on day 2 to assess autonomic nervous function for all participants. Under a sampling rate of 512 Hz, signals from a lead I electrocardiogram were documented by an 8-bit analog-to-digital converter. Fast Fourier transformation was utilized to perform power spectral analysis, which quantified the power spectrum into the standard frequency-domain measurements, including LF (0.04-0.15 Hz), HF (0.15-0.40 Hz) and LF/HF ratio. | After the interventions on day 2 |
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