Heart Rate Variability as an Indicator Associated With the Improvement of Dysmenorrhea After the Warm-water Footbath
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- Pain visual analog scale, post-test
研究概览
简要总结
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).
详细描述
Dysmenorrhea is the most common gynecological condition affecting 16% to 95% of adolescents and young women, and reduce their quality of life. Primary dysmenorrhea (PD), a term denoting the dysmenorrhea in the absence of underlying pathology, is commonly referred to as period pain or menstrual cramps by the lay press and public.
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.
This study was approved by the Institutional Review Board of Saint Mary Hospital Luodong (SMHIRB102015).
This study with a quasi-experimental design was conducted in a nursing college in Northern Taiwan during the study period from December 1, 2013, to June 30, 2014. Participants were eligible for enrollment if they: (1) were 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. The exclusion criteria included individuals whom: (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. The suggested participant's number estimated by the G-Power was 34 when setting the calculated power as 0.8 and α as 0.05. Considering participant loss during the study process, we decided to enroll 68 participants.
All enrolled participants were randomized into the footbath group (n=35) and control group (n=33). The baseline demographic data, as well as relevant information about menstrual cycles and dysmenorrhea of all participants, were documented at enrollment. All the participants were arranged to stay in an air-conditioned, quiet room from 5:30 to 6:30 p.m. on their menstruation days 1 and 2. After sitting quietly for 20 minutes, the participants in the "footbath group" received legs soaking from the heel to the Sanyinjiao (SP6) acupoint (above the ankle) 24 in 42 ℃ water with air bubbles and vibration given to the soles for 20 minutes, whereas the participants in the "control group" kept on sitting quietly without legs soaking during the additional 20-minute period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 20 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Pain visual analog scale, post-test
时间窗: After the intervention of menstruation day 2
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).
Heart rate variability, post-test of day 1
时间窗: After the interventions on 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.
Pain visual analog scale, pre-test
时间窗: Before the intervention of menstruation day 1
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).
Short-Form McGill Pain Questionnaire, pre-test
时间窗: Before the intervention of menstruation day 1
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.
Heart rate variability, pre-test of day 2
时间窗: Before the interventions on 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.
Heart rate variability, post-test of day 2
时间窗: After the interventions on 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.
Short-Form McGill Pain Questionnaire, post-test
时间窗: After the intervention of menstruation day 2
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.
Heart rate variability, pre-test of day 1
时间窗: Before the interventions on 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.
次要结局
未报告次要终点