Pregnancy Clinical Trial
Official title:
Pilot Study: Effects of Relaxing Hydrotherapy WATSU in Third Trimester of Pregnancy, an Explorative Cohort-Study
Verified date | September 2014 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 17 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Obstetrics and Gynecology, University Hospital, Inselspital, Effingerstrasse 102 | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne | BFH Berner Fachhochschule für Gesundheit, University of Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in psychological stress | Day 8 | No | |
Secondary | Low back pain | Days 1, 4, 8, and weekly until birth | No | |
Secondary | Breech presentation | Days 1, 4, 8, and weekly until birth | No | |
Secondary | Quality of Life | Days 1, 4, 8, and weekly until birth | No | |
Secondary | Amount of amniotic fluid | Days 1, 4, 8 | No | |
Secondary | Qualitative questionnaire | Day 4 | No | |
Secondary | Birth (vaginal, cesarean, complications, breech) | after birth | No | |
Secondary | Psychological wellbeing | Days 1, 4, 8 and weekly until birth | No |
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