Primary Dysmenorrhea
Conditions
Keywords
Dysmenorrhea, Women Health, Rhythmical Massage, Anthroposophic Medicine, HRV Biofeedback
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.
Interventions
OTHERRhythmical 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.
BEHAVIORALHRV 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.
Sponsors
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 46 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean pain intensity during menstruation | 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
| Measure | Time frame | Description |
|---|---|---|
| SF-12 sum-score | Baseline (pre intervention) and after three months (post intervention). | Overall quality of life as assessed by the SF-12 questionnaire. |
| SF-12 mental | Baseline (pre intervention) and after three months (post intervention). | Quality of life (subscore mental) as assessed by the SF-12 questionnaire. |
| SF-12 physical | Baseline (pre intervention) and after three months (post intervention). | Quality of life (subscore physical) as assessed by the SF-12 questionnaire. |
| Maximum pain intensity during menstruation | 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. |
| RMSSD | Baseline (pre intervention) and after three months (post intervention). | Root mean square of successive differences, derived from 24h ECGs. |
| LF/HF-Ratio | 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. |
| Analgesics intake during menstruation | Baseline (pre intervention) and after three months (post intervention). | Percentage of participants taking analgesics. |
| SDNN | Baseline (pre intervention) and after three months (post intervention). | Standard deviation of normal to normal beats, derived from 24h ECGs. |
Countries
Germany
Outcome results
None listed