Clinical trial NCT03712800: 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
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Dysmenorrhea
Women Health
Rhythmical Massage
Anthroposophic Medicine
HRV Biofeedback
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 46
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean pain intensity during menstruation
timeFrame: Baseline (pre intervention) and after three months (post intervention).
Secondary outcomes:
measure: Maximum pain intensity during menstruation
timeFrame: Baseline (pre intervention) and after three months (post intervention).
measure: SF-12 sum-score
timeFrame: Baseline (pre intervention) and after three months (post intervention).
measure: SF-12 mental
timeFrame: Baseline (pre intervention) and after three months (post intervention).
measure: SF-12 physical
timeFrame: Baseline (pre intervention) and after three months (post intervention).
measure: SDNN
timeFrame: Baseline (pre intervention) and after three months (post intervention).
measure: RMSSD
timeFrame: Baseline (pre intervention) and after three months (post intervention).
measure: LF/HF-Ratio
timeFrame: Baseline (pre intervention) and after three months (post intervention).
measure: Analgesics intake during menstruation
timeFrame: Baseline (pre intervention) and after three months (post intervention).
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Die Filderklinik
state: Baden-Württemberg
Study officials:
affiliation: Arcim Institute
name: Jan Vagedes, MD, Dr
role: PRINCIPAL_INVESTIGATOR
References: