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

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Status: Completed

Conditions: Primary Dysmenorrhea

Treatments: Behavioral: HRV biofeedback; Other: Rhythmical massage

Study type: Interventional

Funder types: Other

Identifiers

NCT03712800

DYS_01

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 16 to 46 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Rhythmical massage

Experimental group

Description:

Participants who receive rhythmical massage for three months.

Treatment:

Other: Rhythmical massage

HRV biofeedback

Experimental group

Description:

Participants who perform HRV biofeedback for three months.

Treatment:

Behavioral: HRV biofeedback

Control group

No Intervention group

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.