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

Primary Purpose

Primary Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Rhythmical massage
HRV biofeedback
Sponsored by
ARCIM Institute Academic Research in Complementary and Integrative Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Dysmenorrhea, Women Health, Rhythmical Massage, Anthroposophic Medicine, HRV Biofeedback

Eligibility Criteria

16 Years - 46 Years (Child, Adult)FemaleDoes not accept 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.

Sites / Locations

  • Die Filderklinik

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Rhythmical massage

HRV biofeedback

Control group

Arm Description

Participants who receive rhythmical massage for three months.

Participants who perform HRV biofeedback for three months.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Maximum pain intensity during menstruation
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.
SF-12 sum-score
Overall quality of life as assessed by the SF-12 questionnaire.
SF-12 mental
Quality of life (subscore mental) as assessed by the SF-12 questionnaire.
SF-12 physical
Quality of life (subscore physical) as assessed by the SF-12 questionnaire.
SDNN
Standard deviation of normal to normal beats, derived from 24h ECGs.
RMSSD
Root mean square of successive differences, derived from 24h ECGs.
LF/HF-Ratio
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.
Analgesics intake during menstruation
Percentage of participants taking analgesics.

Full Information

First Posted
October 18, 2018
Last Updated
October 18, 2018
Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03712800
Brief Title
Rhythmical Massage Compared With Heart Rate Variability Biofeedback in Women With Menstrual Pain (Dysmenorrhea)
Official Title
Efficacy of Rhythmical Massage in Comparison to Heart Rate Variability Biofeedback in Women With Primary Dysmenorrhea - a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 2012 (Actual)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
Dysmenorrhea, Women Health, Rhythmical Massage, Anthroposophic Medicine, HRV Biofeedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rhythmical massage
Arm Type
Experimental
Arm Description
Participants who receive rhythmical massage for three months.
Arm Title
HRV biofeedback
Arm Type
Experimental
Arm Description
Participants who perform HRV biofeedback for three months.
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Rhythmical massage
Intervention Description
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
Behavioral
Intervention Name(s)
HRV biofeedback
Intervention Description
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 Outcome Measure Information:
Title
Mean pain intensity during menstruation
Description
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.
Time Frame
Baseline (pre intervention) and after three months (post intervention).
Secondary Outcome Measure Information:
Title
Maximum pain intensity during menstruation
Description
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.
Time Frame
Baseline (pre intervention) and after three months (post intervention).
Title
SF-12 sum-score
Description
Overall quality of life as assessed by the SF-12 questionnaire.
Time Frame
Baseline (pre intervention) and after three months (post intervention).
Title
SF-12 mental
Description
Quality of life (subscore mental) as assessed by the SF-12 questionnaire.
Time Frame
Baseline (pre intervention) and after three months (post intervention).
Title
SF-12 physical
Description
Quality of life (subscore physical) as assessed by the SF-12 questionnaire.
Time Frame
Baseline (pre intervention) and after three months (post intervention).
Title
SDNN
Description
Standard deviation of normal to normal beats, derived from 24h ECGs.
Time Frame
Baseline (pre intervention) and after three months (post intervention).
Title
RMSSD
Description
Root mean square of successive differences, derived from 24h ECGs.
Time Frame
Baseline (pre intervention) and after three months (post intervention).
Title
LF/HF-Ratio
Description
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.
Time Frame
Baseline (pre intervention) and after three months (post intervention).
Title
Analgesics intake during menstruation
Description
Percentage of participants taking analgesics.
Time Frame
Baseline (pre intervention) and after three months (post intervention).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Vagedes, MD, Dr
Organizational Affiliation
Arcim Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Die Filderklinik
City
Filderstadt
State/Province
Baden-Württemberg
ZIP/Postal Code
70794
Country
Germany

12. IPD Sharing Statement

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

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