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Heart Rate Variability as an Indicator Associated With the Improvement of Dysmenorrhea After the Warm-water Footbath

Primary Purpose

Primary Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
warm-water footbath
Sponsored by
Camillians Saint Mary's Hospital Luodong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Primary Dysmenorrhea focused on measuring footbath, parasympathetic activity, primary dysmenorrhea, sympathetic activity

Eligibility Criteria

16 Years - 20 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Footbath group

    Control group

    Arm Description

    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,

    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, whereas the participants in the "control group" kept on sitting quietly without legs soaking during the additional 20-minute period.

    Outcomes

    Primary Outcome Measures

    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).
    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).
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 6, 2019
    Last Updated
    August 26, 2019
    Sponsor
    Camillians Saint Mary's Hospital Luodong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04071028
    Brief Title
    Heart Rate Variability as an Indicator Associated With the Improvement of Dysmenorrhea After the Warm-water Footbath
    Official Title
    Heart Rate Variability as an Indicator Associated With the Improvement of Dysmenorrhea After the Warm-water Footbath
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 15, 2013 (Actual)
    Primary Completion Date
    June 30, 2014 (Actual)
    Study Completion Date
    June 30, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Camillians Saint Mary's Hospital Luodong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).
    Detailed Description
    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. PVAS and Short-Form McGill Pain Questionnaire (SF-MPQ) were fulfilled as pain assessment by all participants twice, including a "pre-test" before the intervention of menstruation day 1 and a "post-test" after the intervention of menstruation day 2. HRV was measured at four time points (before and immediately after the interventions on days 1 and 2) to assess ANS function for all participants. The interventions were "warm-water footbath for 20 minutes" for the "footbath group" and "sitting quietly without footbath for 20 minutes" for the "control group." Then we evaluated the influence of warm-water footbath on dysmenorrhea and several variables, including HRV indices and stiffness index.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Dysmenorrhea
    Keywords
    footbath, parasympathetic activity, primary dysmenorrhea, sympathetic activity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    68 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Footbath group
    Arm Type
    Active Comparator
    Arm Description
    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,
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    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, whereas the participants in the "control group" kept on sitting quietly without legs soaking during the additional 20-minute period.
    Intervention Type
    Procedure
    Intervention Name(s)
    warm-water footbath
    Intervention Description
    All the participants in the intervention group 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.
    Primary Outcome Measure Information:
    Title
    Pain visual analog scale, pre-test
    Description
    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).
    Time Frame
    Before the intervention of menstruation day 1
    Title
    Pain visual analog scale, post-test
    Description
    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).
    Time Frame
    After the intervention of menstruation day 2
    Title
    Short-Form McGill Pain Questionnaire, pre-test
    Description
    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.
    Time Frame
    Before the intervention of menstruation day 1
    Title
    Short-Form McGill Pain Questionnaire, post-test
    Description
    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.
    Time Frame
    After the intervention of menstruation day 2
    Title
    Heart rate variability, pre-test of day 1
    Description
    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.
    Time Frame
    Before the interventions on day 1
    Title
    Heart rate variability, post-test of day 1
    Description
    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.
    Time Frame
    After the interventions on day 1
    Title
    Heart rate variability, pre-test of day 2
    Description
    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.
    Time Frame
    Before the interventions on day 2
    Title
    Heart rate variability, post-test of day 2
    Description
    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.
    Time Frame
    After the interventions on day 2

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Healthy female students aged 16-20 years with primary dysmenorrhea
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria: healthy female students aged 16-20 years of the nursing college; had regular menstrual cycles; experienced dysmenorrhea within 6 months before the enrollment; had dysmenorrhea with severity higher than five scores of the pain visual analog scale (PVAS); and had no experience of pregnancy. Exclusion criteria: had irregular menstrual cycles; had circulation problem of legs such as peripheral arterial occlusive disease or deep vein thrombosis; had wounds or skin lesions over legs; and had taken any medications which affect ANS activity.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wu Shih-Ju
    Organizational Affiliation
    Saint Mary's Hospital Luodong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34560833
    Citation
    Wu SJ, Kan WC, Shiao CC. Warm-water footbath improves dysmenorrhoea and heart rate variability in college students: a randomised controlled trial. J Obstet Gynaecol. 2022 Jul;42(5):1204-1210. doi: 10.1080/01443615.2021.1945007. Epub 2021 Sep 24.
    Results Reference
    derived

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    Heart Rate Variability as an Indicator Associated With the Improvement of Dysmenorrhea After the Warm-water Footbath

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