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Completed

NCT Number: NCT03712800

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

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

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Key information

Conditions

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

Age range

16 year–46 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Die Filderklinik

Filderstadt, Baden-Wurttemberg, 70794, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Mean pain intensity during menstruation

    Time frame: Baseline (pre intervention) and after three months (post intervention).

    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.

Secondary outcomes

  1. Maximum pain intensity during menstruation

    Time frame: Baseline (pre intervention) and after three months (post intervention).

    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.

  2. SF-12 sum-score

    Time frame: Baseline (pre intervention) and after three months (post intervention).

    Overall quality of life as assessed by the SF-12 questionnaire.

  3. SF-12 mental

    Time frame: Baseline (pre intervention) and after three months (post intervention).

    Quality of life (subscore mental) as assessed by the SF-12 questionnaire.

  4. SF-12 physical

    Time frame: Baseline (pre intervention) and after three months (post intervention).

    Quality of life (subscore physical) as assessed by the SF-12 questionnaire.

  5. SDNN

    Time frame: Baseline (pre intervention) and after three months (post intervention).

    Standard deviation of normal to normal beats, derived from 24h ECGs.

  6. RMSSD

    Time frame: Baseline (pre intervention) and after three months (post intervention).

    Root mean square of successive differences, derived from 24h ECGs.

  7. LF/HF-Ratio

    Time frame: Baseline (pre intervention) and after three months (post intervention).

    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.

  8. Analgesics intake during menstruation

    Time frame: Baseline (pre intervention) and after three months (post intervention).

    Percentage of participants taking analgesics.

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 19, 2018
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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