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

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ClinicalTrials.gov Identifier: NCT03712800
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Primary Dysmenorrhea Other: Rhythmical massage Behavioral: HRV biofeedback Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Rhythmical Massage in Comparison to Heart Rate Variability Biofeedback in Women With Primary Dysmenorrhea - a Randomized, Controlled Trial
Actual Study Start Date : February 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rhythmical massage
Participants who receive rhythmical massage for three months.
Other: 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.

Experimental: HRV biofeedback
Participants who perform HRV biofeedback for three months.
Behavioral: 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.

No Intervention: 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   16 Years to 46 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712800


Locations
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Germany
Die Filderklinik
Filderstadt, Baden-Württemberg, Germany, 70794
Sponsors and Collaborators
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Investigators
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Principal Investigator: Jan Vagedes, MD, Dr Arcim Institute

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Responsible Party: ARCIM Institute Academic Research in Complementary and Integrative Medicine
ClinicalTrials.gov Identifier: NCT03712800     History of Changes
Other Study ID Numbers: DYS_01
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ARCIM Institute Academic Research in Complementary and Integrative Medicine:
Dysmenorrhea
Women Health
Rhythmical Massage
Anthroposophic Medicine
HRV Biofeedback

Additional relevant MeSH terms:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms