- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01708018
Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy
Pilot Study: Effects of Relaxing Hydrotherapy WATSU in Third Trimester of Pregnancy, an Explorative Cohort-Study
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).
Study Overview
Status
Intervention / Treatment
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.
The described effects of WATSU on muscle tone might be of interest in case of breech presentations. Tension of the uterus has major influence on the success of attempts of external cephalic version. Although breech presentation occurs in 3-4% of pregnancies only, this complication is a threat to the mothers as well as the infants life. External cephalic version to correct the child's position is being suggested although associated with risks for mother and child. Breech presentations are the most frequent medical indication for cesarean sections.
The impacts of stress on unborn children are being investigated, long-term effects are being speculated.
Objective
In contrast to active hydrotherapy, passive hydrotherapy was not yet subject of investigation concerning its effects during pregnancy. The goals of this pilot-study are:
- To evaluate the effects of passive hydrotherapy WATSU in the third trimester of pregnancy by the means of a scientific prospective approach and to ascertain, whether the reported effects can be observed under such conditions
- To evaluate the therapeutic potential of WATSU
- To evaluate the usefulness, feasibility and framework requirements of further RCT addressing this issue
- To evaluate, whether or not - which of, respectively - the chosen parameter are suitable for further investigations (RCT)
- To evaluate potential for improvement in study design and management.
Methods
Design: pilot-study, explorative comparison of two cohorts. Criterion for pseudorandomisation: immersion contraindicated (e.g. due to perforation of the eardrum). Recruitment from July to December 2012; expected participants: 45.
Parameter: ultrasound examination of position of the fetus and amount of amniotic fluid; qualitative and quantitative questionnaires, birth outcome (vaginal, cesarean, complications, breech presentation).
Statistics: SPSS; significance at p<.05, Intention to Treat.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bern, Switzerland, 3010 Bern
- Department of Obstetrics and Gynecology, University Hospital, Inselspital, Effingerstrasse 102
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 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.
|
|
Experimental: 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.
|
WATSU (WaterShiatsu) is a gentle form of hydrotherapy that was established in the 1980s. The standardized 60min-intervention applied in this trial is called WATSU-Transition-Flow (Dull, 1997) and is adapted for the third trimester. The mother's abdomen is not being touched during the treatment. The treatment takes place in a one-to-one hands-on-setting in the warm- water-therapy-pool (35°C, 95°F) of the University Hospital in Bern and consists of acupressure massage according to the Japanese massage-technique Shiatsu, in an attempt to harmonize the mother's "energy-flow" in the so called "meridians" (energy-channels) of Traditional Chinese Medicine. These "meridians" are also sought to be influenced by slow passive stretches of the mother's extremities. In addition, mobilization of her spine is being enhanced by gravity-free movements. During the study, each participant in the intervention group will be treated twice with WATSU (60min treatment at day 1 and 4). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in psychological stress
Time Frame: Day 8
|
Day 8
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Low back pain
Time Frame: Days 1, 4, 8, and weekly until birth
|
Days 1, 4, 8, and weekly until birth
|
Breech presentation
Time Frame: Days 1, 4, 8, and weekly until birth
|
Days 1, 4, 8, and weekly until birth
|
Quality of Life
Time Frame: Days 1, 4, 8, and weekly until birth
|
Days 1, 4, 8, and weekly until birth
|
Amount of amniotic fluid
Time Frame: Days 1, 4, 8
|
Days 1, 4, 8
|
Qualitative questionnaire
Time Frame: Day 4
|
Day 4
|
Birth (vaginal, cesarean, complications, breech)
Time Frame: after birth
|
after birth
|
Psychological wellbeing
Time Frame: Days 1, 4, 8 and weekly until birth
|
Days 1, 4, 8 and weekly until birth
|
Collaborators and Investigators
Investigators
- Study Chair: Daniel Surbek, Prof. Dr. med., Department of Obstetrics and Gynecology, University Hospital Bern
- Study Director: Luigi Raio, PD Dr. med., Department of Obstetrics and Gynecology, University Hospital Bern
- Study Director: Agnes M Schitter, MSc PT, BFH Bern University of Applied Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 058/12
- Studytyp A, Nr. 2211
- SAP-Fall-Nr.: 3991344
- SAP-Patient: 11095660
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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