Pilot Study: Effects of Relaxing Hydrotherapy WATSU in Third Trimester of Pregnancy, an Explorative Cohort-Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Change from baseline in psychological stress
Study Overview
Brief Summary
This study will be the first scientific approach to investigate physical and psychological effects of the passive hydrotherapy-method WATSU (WaterShiatsu) on women and their unborn children at the third trimester of pregnancy. Potential therapeutic benefits of the method shall be evaluated.
It is being hypothesized that WATSU is related to measurable changes in everyday stress perception, psychological wellbeing, quality of life, pregnancy-related low back pain, tonus of the uterus, amount of amniotic fluid, spontaneous course of breech presentations, prospects of external cephalic versions.
Participants in the intervention-group will be treated twice with WATSU (60 minutes per treatment, standardized sequence) in the >36th week of pregnancy. There will not be any sham-intervention in the control-group. Both groups will be examined by ultrasound (prior and after the treatments plus on day 8 of the trial) and answer questionnaires (prior and after the treatments plus once a week until birth).
Detailed Description
Background
Within the last 20 years, evidence supporting harmlessness and benefits of hydrotherapy during pregnancy accumulated. Water gymnastics were observed to have pain-relieving effects, as was birth in water.
WATSU is an acronym, based on the terms Water and Shiatsu. It is a relaxing form of hydrotherapy which is performed in 35° C (95° F). Practitioners claim WATSU to lower muscular tonus as well as stress and to relief pain. Clinically relevant regulation of muscular tonus in spastic hemiparetic patients due to WATSU was observed by Chon; significant reduction of pain in patients suffering fibromyalgia by Faull.
In respect of pregnancy, WATSU is narrated - yet not scientifically evaluated - to reduce pregnancy-related low back pain, to relax hypertonic muscles including those of the uterus, to improve the overall sense of wellbeing and deepen the relationship of the mother to her unborn child. In addition, spontaneous cephalic versions of children in breech presentations within 1 to 4 days and nights following WATSU-treatments are being claimed.
According to Pennick & Young, two of three pregnant women are suffering pregnancy-related low back pain. Since this population is recommended to refrain from analgesic medications, potentially helpful interventions ought to be identified.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy women
- •singleton pregnancy
- •without pathological findings
- •at week of gestation >36+0
- •fluent German
- •Pregnancy related low back pain
- •breech presentation
- •written informed consent
Exclusion Criteria
- •Neurological deficits resulting from low back pain
- •already ongoing WATSU-treatment
Arms & Interventions
Control group
Prior and post intervention period (on days 1 and 4) and final control (day 8): ultrasound examination of position of the fetus and amount of amniotic fluid. On these days plus weekly (until birth) questionnaires (QoL: SF-36, EQ-5D-5L, stress: PSS, psychological wellbeing: MDBF, current stress and pain: VAS). Survey concerning birth.
Intervention group
Prior and post intervention (days 1 and 4) and final control (day 8): ultrasound examination of position of the fetus and amount of amniotic fluid. On these days plus weekly (until birth) questionnaires (QoL: SF-36, EQ-5D-5L, stress: PSS, psychological wellbeing: MDBF, current stress and pain: VAS). After the second intervention(day 4): qualitative questionnaire for intervention-group only. Survey concerning birth.
Intervention: WATSU (Procedure)
Outcomes
Primary Outcomes
Change from baseline in psychological stress
Time Frame: Day 8
Secondary Outcomes
- Amount of amniotic fluid(Days 1, 4, 8)
- Qualitative questionnaire(Day 4)
- Birth (vaginal, cesarean, complications, breech)(after birth)
- Psychological wellbeing(Days 1, 4, 8 and weekly until birth)
- Low back pain(Days 1, 4, 8, and weekly until birth)
- Breech presentation(Days 1, 4, 8, and weekly until birth)
- Quality of Life(Days 1, 4, 8, and weekly until birth)