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

NCT04071028 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2019-08-28

No results posted yet for this study

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

Interventions

PROCEDURE

warm-water footbath

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.

Sponsors & Collaborators

  • Camillians Saint Mary's Hospital Luodong

    lead OTHER

Principal Investigators

  • Wu Shih-Ju · Saint Mary's Hospital Luodong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
20 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-15
Primary Completion
2014-06-30
Completion
2014-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04071028 on ClinicalTrials.gov