Primary DysmenorrheaNCT03712800
Rhythmical Massage Compared With Heart Rate Variability Biofeedback in Women With Menstrual Pain (Dysmenorrhea)
A study testing Rhythmical massage and HRV biofeedback in people with Primary Dysmenorrhea, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 46 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Rhythmical massage and HRV biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 46 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Secondary dysmenorrhea.
- Participation in another study.
- Mental retardation.
- Addiction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Rhythmical Massage in Comparison to Heart Rate Variability Biofeedback in Women With Primary Dysmenorrhea - a Randomized, Controlled Trial
A study to explore whether rhythmical massage and heart rate variability biofeedback can help to reduce pain in women suffering from menstrual pain (dysmenorrhea).
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Rhythmical massage, HRV biofeedback
- Keywords
- Dysmenorrhea, Women Health, Rhythmical Massage, Anthroposophic Medicine, HRV Biofeedback
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmical massageOther
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 biofeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Rhythmical massage | Experimental | Participants who receive rhythmical massage for three months. Receives: Other: Rhythmical massage |
| HRV biofeedback | Experimental | Participants who perform HRV biofeedback for three months. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre intervention) and after three months (post intervention).
Secondary outcomes (8)
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.
Measured: Baseline (pre intervention) and after three months (post intervention).
SF-12 sum-score
Overall quality of life as assessed by the SF-12 questionnaire.
Measured: Baseline (pre intervention) and after three months (post intervention).
SF-12 mental
Quality of life (subscore mental) as assessed by the SF-12 questionnaire.
Measured: Baseline (pre intervention) and after three months (post intervention).
SF-12 physical
Quality of life (subscore physical) as assessed by the SF-12 questionnaire.
Measured: Baseline (pre intervention) and after three months (post intervention).
SDNN
Standard deviation of normal to normal beats, derived from 24h ECGs.
Measured: Baseline (pre intervention) and after three months (post intervention).
RMSSD
Root mean square of successive differences, derived from 24h ECGs.
Measured: Baseline (pre intervention) and after three months (post intervention).
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.
Measured: Baseline (pre intervention) and after three months (post intervention).
Analgesics intake during menstruation
Percentage of participants taking analgesics.
Measured: Baseline (pre intervention) and after three months (post intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study startFeb 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, MD, Dr, Principal investigator, Arcim Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712800
- Sponsor's protocol ID
- DYS_01
- Status last verified
- Oct 2018
- First submitted
- 18 Oct 2018
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rhythmical Massage in Comparison to Heart Rate Variability Biofeedback in Women With Primary Dysmenorrhea - a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03712800
- Acronym / sponsor ID
- DYS_01
- Conditions
- Primary Dysmenorrhea
- Keywords
- Dysmenorrhea, Women Health, Rhythmical Massage, Anthroposophic Medicine, HRV Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Rhythmical massage | Experimental | Other: Rhythmical massageParticipants who receive rhythmical massage for three months. |
| HRV biofeedback | Experimental | Behavioral: HRV biofeedbackParticipants who perform HRV biofeedback for three months. |
| 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. |
Who may qualify
- Ages
- 16 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Secondary dysmenorrhea.
- Participation in another study.
- Mental retardation.
- Addiction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhythmical massageRhythmical 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. | Other | Rhythmical massage |
| HRV biofeedbackOne 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. | Behavioural | HRV biofeedback |
Primary outcome
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.
8 secondary outcomes
Maximum pain intensity during menstruation
Time frame: Baseline (pre intervention) and after three months (post intervention).
SF-12 sum-score
Time frame: Baseline (pre intervention) and after three months (post intervention).
SF-12 mental
Time frame: Baseline (pre intervention) and after three months (post intervention).
SF-12 physical
Time frame: Baseline (pre intervention) and after three months (post intervention).
SDNN
Time frame: Baseline (pre intervention) and after three months (post intervention).
RMSSD
Time frame: Baseline (pre intervention) and after three months (post intervention).
LF/HF-Ratio
Time frame: Baseline (pre intervention) and after three months (post intervention).
Analgesics intake during menstruation
Time frame: Baseline (pre intervention) and after three months (post intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Vagedes, MD, Dr principal investigator
Arcim Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmical massage and HRV biofeedback in people with Primary Dysmenorrhea, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean pain intensity during menstruation (time frame: Baseline (pre intervention) and after three months (post intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.