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

NCT03712800 | Completed

• 1 other identifier: DYS_01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Primary Dysmenorrhea

Keywords

Dysmenorrhea; Women Health; Rhythmical Massage; Anthroposophic Medicine; HRV Biofeedback

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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).

Study Arms (3)

Rhythmical massage

EXPERIMENTAL

Participants who receive rhythmical massage for three months.

Other: Rhythmical massage

HRV biofeedback

EXPERIMENTAL

Participants who perform HRV biofeedback for three months.

Behavioral: HRV biofeedback

Control group

NO INTERVENTION

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.

Interventions

Rhythmical massage 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.

Rhythmical massage

HRV biofeedback 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.

HRV biofeedback

Eligibility Criteria

• Age: 16 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Secondary dysmenorrhea.
• Participation in another study.
• Mental retardation.
• Addiction.

Sponsors & Collaborators

• ARCIM Institute Academic Research in Complementary and Integrative Medicine: lead

Study Sites (1)

Die Filderklinik

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jan Vagedes, MD, Dr

  Arcim Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 19, 2018
• Study Start: February 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 19, 2018

Record last verified: 2018-10

Locations

DE (1)