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

Not Applicable

Completed

• Conditions: Primary Dysmenorrhea
• Interventions: Other: Rhythmical massage; Behavioral: HRV biofeedback

• Registration Number: NCT03712800
• Lead Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine

Brief Summary

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

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 Timeline

• Study Start: 2012-02
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2018-10
• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-18
• Last Update Submitted: 2018-10-18
• Study First Posted: 2018-10-19
• Last Update Posted: 2018-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rhythmical massage	Rhythmical massage	Participants who receive rhythmical massage for three months.
HRV biofeedback	HRV biofeedback	Participants who perform HRV biofeedback for three months.

Primary Outcome Measures

Name	Time	Method
Mean pain intensity during menstruation	Baseline (pre intervention) and after three months (post intervention).	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.

Secondary Outcome Measures

Name	Time	Method
Analgesics intake during menstruation	Baseline (pre intervention) and after three months (post intervention).	Percentage of participants taking analgesics.
SF-12 sum-score	Baseline (pre intervention) and after three months (post intervention).	Overall quality of life as assessed by the SF-12 questionnaire.
RMSSD	Baseline (pre intervention) and after three months (post intervention).	Root mean square of successive differences, derived from 24h ECGs.
Maximum pain intensity during menstruation	Baseline (pre intervention) and after three months (post intervention).	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.
SF-12 mental	Baseline (pre intervention) and after three months (post intervention).	Quality of life (subscore mental) as assessed by the SF-12 questionnaire.
SF-12 physical	Baseline (pre intervention) and after three months (post intervention).	Quality of life (subscore physical) as assessed by the SF-12 questionnaire.
LF/HF-Ratio	Baseline (pre intervention) and after three months (post intervention).	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.
SDNN	Baseline (pre intervention) and after three months (post intervention).	Standard deviation of normal to normal beats, derived from 24h ECGs.

Trial Locations

Locations (1)

Die Filderklinik; 🇩🇪 Filderstadt, Baden-Württemberg, Germany