Rhythmical Massage Compared With Heart Rate Variability Biofeedback in Women With Menstrual Pain (Dysmenorrhea)

Efficacy of Rhythmical Massage in Comparison to Heart Rate Variability Biofeedback in Women With Primary Dysmenorrhea - a Randomized, Controlled Trial

A study to explore whether rhythmical massage and heart rate variability biofeedback can help to reduce pain in women suffering from menstrual pain (dysmenorrhea).

Study Overview

• Status: Completed
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Other: Rhythmical massage; Behavioral: HRV biofeedback

Detailed Description

This is a three-arm randomized controlled trial to evaluate the efficacy of rhythmical massage and HRV biofeedback in women with primary dysmenorrhea compared to a control group. The main focus is on pain intensity during menstruation. Moreover, analgesics intake, SF-12 mental and physical scores and parameters of a 24h-HRV measurement are assessed before and after the three-month intervention.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Filderstadt, Baden-Württemberg, Germany, 70794
      • Die Filderklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 46 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• At least one year of primary dysmenorrhea (physician-confirmed).
• Written informed consent (also from parents/legal guardians of underage girls).
• Menarche at least one year ago.

Exclusion Criteria:

• Secondary dysmenorrhea.
• Participation in another study.
• Mental retardation.
• Addiction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Rhythmical massage; Participants who receive rhythmical massage for three months.	Other: Rhythmical massage; Rhythmical Massage according to Dr Ita Wegman, derived from Swedish Massage in the 1920s. Applied for various indications in the context of Anthroposophic Medicine, aiming at a recovery of self-regulation and self-healing forces.
EXPERIMENTAL: HRV biofeedback; Participants who perform HRV biofeedback for three months.	Behavioral: HRV biofeedback; One of various biofeedback types, HRV biofeedback gives a visual feedback of the participant's heart rate variability as an indicator for general health, physical and cognitive performance, self-regulation and a decreased risk of illness.
NO_INTERVENTION: Control group; Participants who do not receive an intervention during the three-month intervention period but are advised to stay with their usual care during menstrual pain. For ethical and compliance reasons, these participants receive a series of rhythmical massage treatments after the initial three-month intervention/control period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean pain intensity during menstruation	Mean pain intensity on the three days of maximal menstrual discomfort, as indicated by the participants on a numeric rating scale in a pain diary.	Baseline (pre intervention) and after three months (post intervention).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum pain intensity during menstruation	Maximum pain intensity on the three days of maximal menstrual discomfort, as indicated by the participants on a numeric rating scale in a pain diary.	Baseline (pre intervention) and after three months (post intervention).
SF-12 sum-score	Overall quality of life as assessed by the SF-12 questionnaire.	Baseline (pre intervention) and after three months (post intervention).
SF-12 mental	Quality of life (subscore mental) as assessed by the SF-12 questionnaire.	Baseline (pre intervention) and after three months (post intervention).
SF-12 physical	Quality of life (subscore physical) as assessed by the SF-12 questionnaire.	Baseline (pre intervention) and after three months (post intervention).
SDNN	Standard deviation of normal to normal beats, derived from 24h ECGs.	Baseline (pre intervention) and after three months (post intervention).
RMSSD	Root mean square of successive differences, derived from 24h ECGs.	Baseline (pre intervention) and after three months (post intervention).
LF/HF-Ratio	LF/HF-Ratio = Ratio of two bands from frequency domain analysis: LF band (0.04-0.15 Hz), HF band (0.15-0.40 Hz), derived from 24h ECGs.	Baseline (pre intervention) and after three months (post intervention).
Analgesics intake during menstruation	Percentage of participants taking analgesics.	Baseline (pre intervention) and after three months (post intervention).

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Investigators: Principal Investigator: Jan Vagedes, MD, Dr, Arcim Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2012
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (ACTUAL): October 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Dysmenorrhea; HRV Biofeedback; Women Health; Rhythmical Massage; Anthroposophic Medicine
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: DYS_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No