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A study to explore whether rhythmical massage and heart rate variability biofeedback can help to reduce pain in women suffering from menstrual pain (dysmenorrhea).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rhythmical massage | Experimental | Participants who receive rhythmical massage for three months. |
|
| HRV biofeedback | Experimental | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (pre intervention) and after three months (post intervention). |
| SF-12 sum-score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Vagedes, MD, Dr | Arcim Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Die Filderklinik | Filderstadt | Baden-Wurttemberg | 70794 | Germany |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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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.
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| 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. |
|
Overall quality of life as assessed by the SF-12 questionnaire. |
| Baseline (pre intervention) and after three months (post intervention). |
| SF-12 mental | Quality of life (subscore mental) as assessed by the SF-12 questionnaire. | Baseline (pre intervention) and after three months (post intervention). |
| SF-12 physical | Quality of life (subscore physical) as assessed by the SF-12 questionnaire. | Baseline (pre intervention) and after three months (post intervention). |
| SDNN | Standard deviation of normal to normal beats, derived from 24h ECGs. | Baseline (pre intervention) and after three months (post intervention). |
| RMSSD | Root mean square of successive differences, derived from 24h ECGs. | 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. | Baseline (pre intervention) and after three months (post intervention). |
| Analgesics intake during menstruation | Percentage of participants taking analgesics. | Baseline (pre intervention) and after three months (post intervention). |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |