Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01708018|
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : September 10, 2014
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).
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Breech Presentation Low Back Pain Stress, Psychological||Procedure: WATSU||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study: Effects of Relaxing Hydrotherapy WATSU in Third Trimester of Pregnancy, an Explorative Cohort-Study|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
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).
- Change from baseline in psychological stress [ Time Frame: Day 8 ]
- Low back pain [ Time Frame: Days 1, 4, 8, and weekly until birth ]
- Breech presentation [ Time Frame: Days 1, 4, 8, and weekly until birth ]
- Quality of Life [ Time Frame: Days 1, 4, 8, and weekly until birth ]
- Amount of amniotic fluid [ Time Frame: Days 1, 4, 8 ]
- Qualitative questionnaire [ Time Frame: Day 4 ]
- Birth (vaginal, cesarean, complications, breech) [ Time Frame: after birth ]
- Psychological wellbeing [ Time Frame: Days 1, 4, 8 and weekly until birth ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708018
|Department of Obstetrics and Gynecology, University Hospital, Inselspital, Effingerstrasse 102|
|Bern, Switzerland, 3010 Bern|
|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|