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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
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.
Die Filderklinik
Filderstadt, Baden-Wurttemberg, Germany
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.
Time frame: Baseline (pre intervention) and after three months (post intervention).
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.
Time frame: Baseline (pre intervention) and after three months (post intervention).
SF-12 sum-score
Overall quality of life as assessed by the SF-12 questionnaire.
Time frame: Baseline (pre intervention) and after three months (post intervention).
SF-12 mental
Quality of life (subscore mental) as assessed by the SF-12 questionnaire.
Time frame: Baseline (pre intervention) and after three months (post intervention).
SF-12 physical
Quality of life (subscore physical) as assessed by the SF-12 questionnaire.
Time frame: Baseline (pre intervention) and after three months (post intervention).
SDNN
Standard deviation of normal to normal beats, derived from 24h ECGs.
Time frame: Baseline (pre intervention) and after three months (post intervention).
RMSSD
Root mean square of successive differences, derived from 24h ECGs.
Time frame: Baseline (pre intervention) and after three months (post intervention).
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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.
Time frame: Baseline (pre intervention) and after three months (post intervention).
Analgesics intake during menstruation
Percentage of participants taking analgesics.
Time frame: Baseline (pre intervention) and after three months (post intervention).