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

Sponsors

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

Source 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.

Overall Status Completed
Start Date 2012-02-01
Completion Date 2014-03-01
Primary Completion Date 2014-03-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean pain intensity during menstruation Baseline (pre intervention) and after three months (post intervention).
Secondary Outcome
Measure Time Frame
Maximum pain intensity during menstruation Baseline (pre intervention) and after three months (post intervention).
SF-12 sum-score Baseline (pre intervention) and after three months (post intervention).
SF-12 mental Baseline (pre intervention) and after three months (post intervention).
SF-12 physical Baseline (pre intervention) and after three months (post intervention).
SDNN Baseline (pre intervention) and after three months (post intervention).
RMSSD Baseline (pre intervention) and after three months (post intervention).
LF/HF-Ratio Baseline (pre intervention) and after three months (post intervention).
Analgesics intake during menstruation Baseline (pre intervention) and after three months (post intervention).
Enrollment 60
Condition
Intervention

Intervention Type: Other

Intervention Name: Rhythmical massage

Description: 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.

Arm Group Label: Rhythmical massage

Intervention Type: Behavioral

Intervention Name: HRV biofeedback

Description: 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.

Arm Group Label: HRV biofeedback

Eligibility

Criteria:

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.

Gender:

Female

Minimum Age:

16 Years

Maximum Age:

46 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Jan Vagedes, MD, Dr Principal Investigator Arcim Institute
Location
Facility: Die Filderklinik
Location Countries

Germany

Verification Date

2018-10-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Rhythmical massage

Type: Experimental

Description: Participants who receive rhythmical massage for three months.

Label: HRV biofeedback

Type: Experimental

Description: Participants who perform HRV biofeedback for three months.

Label: Control group

Type: No Intervention

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Participants are randomized to one of the three groups (rhythmical massage, HRV biofeedback or control). After the three-month intervention period, the controls receive rhythmical massage for ethical and compliance reasons. Assessments are taken before and after the intervention phase. Pain intensity is once more queried three months after the end of the intervention period.

Primary Purpose: Treatment

Masking: None (Open Label)

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