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

Primary Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712800
• Other study ID #: DYS_01
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: March 2014

Study information

• Verified date: October 2018
• Source: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 46 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

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.

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.

Locations

Country	Name	City	State
Germany	Die Filderklinik	Filderstadt	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	SF-12 sum-score	Overall quality of life as assessed by the SF-12 questionnaire.	Baseline (pre intervention) and after three months (post intervention).
Secondary	SF-12 mental	Quality of life (subscore mental) as assessed by the SF-12 questionnaire.	Baseline (pre intervention) and after three months (post intervention).
Secondary	SF-12 physical	Quality of life (subscore physical) as assessed by the SF-12 questionnaire.	Baseline (pre intervention) and after three months (post intervention).
Secondary	SDNN	Standard deviation of normal to normal beats, derived from 24h ECGs.	Baseline (pre intervention) and after three months (post intervention).
Secondary	RMSSD	Root mean square of successive differences, derived from 24h ECGs.	Baseline (pre intervention) and after three months (post intervention).
Secondary	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).
Secondary	Analgesics intake during menstruation	Percentage of participants taking analgesics.	Baseline (pre intervention) and after three months (post intervention).