Clinical Trial: Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pilot Study: Effects of Relaxing Hydrotherapy WATSU in Third Trimester of Pregnancy, an Explorative Cohort-Study

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 Summary:

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 ch
Sponsor: University Hospital Inselspital, Berne

Current Primary Outcome: Change from baseline in psychological stress [ Time Frame: Day 8 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: University Hospital Inselspital, Berne

Dates:
Date Received: October 8, 2012
Date Started: July 2012
Date Completion:
Last Updated: September 9, 2014
Last Verified: September 2014