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

NCT04071028 | Completed

• 1 other identifier: SMHL_HRVnFB
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Primary Dysmenorrhea

Keywords

footbath; parasympathetic activity; primary dysmenorrhea; sympathetic activity

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Footbath group

ACTIVE COMPARATOR

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,

Procedure: warm-water footbath

Control group

NO INTERVENTION

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.

Interventions

warm-water footbath PROCEDURE

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.

Footbath group

Eligibility Criteria

• Age: 16 Years - 20 Years
• Gender Eligibility Details: Healthy female students aged 16-20 years with primary dysmenorrhea
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Camillians Saint Mary's Hospital Luodong: lead

Related Publications (1)

• 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.

  PMID: 34560833 DERIVED

Study Officials

• Wu Shih-Ju

  Saint Mary's Hospital Luodong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 28, 2019
• Study Start: December 15, 2013
• Primary Completion: June 30, 2014
• Study Completion: June 30, 2014
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share