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

NCT ID: NCT03712800

Last Updated: 2018-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Primary Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rhythmical massage

Participants who receive rhythmical massage for three months.

Group Type EXPERIMENTAL

Rhythmical massage

Intervention Type OTHER

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.

HRV biofeedback

Participants who perform HRV biofeedback for three months.

Group Type EXPERIMENTAL

HRV biofeedback

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

46 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ARCIM Institute Academic Research in Complementary and Integrative Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Vagedes, MD, Dr

Role: PRINCIPAL_INVESTIGATOR

Arcim Institute

Locations

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Die Filderklinik

Filderstadt, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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DYS_01

Identifier Type: -

Identifier Source: org_study_id

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