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Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01708018
First Posted: October 16, 2012
Last Update Posted: September 10, 2014
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.
Collaborators:
BFH Berner Fachhochschule für Gesundheit
University of Bern
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
  Purpose

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 Intervention
Pregnancy Breech Presentation Low Back Pain Stress, Psychological Procedure: WATSU

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study: Effects of Relaxing Hydrotherapy WATSU in Third Trimester of Pregnancy, an Explorative Cohort-Study

Further study details as provided by University Hospital Inselspital, Berne:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 17
Study Start Date: July 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: WATSU

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).


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Switzerland
Department of Obstetrics and Gynecology, University Hospital, Inselspital, Effingerstrasse 102
Bern, Switzerland, 3010 Bern
Sponsors and Collaborators
University Hospital Inselspital, Berne
BFH Berner Fachhochschule für Gesundheit
University of Bern
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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01708018     History of Changes
Other Study ID Numbers: 058/12
Studytyp A, Nr. 2211
SAP-Fall-Nr.: 3991344
SAP-Patient: 11095660
First Submitted: October 8, 2012
First Posted: October 16, 2012
Last Update Posted: September 10, 2014
Last Verified: September 2014

Keywords provided by University Hospital Inselspital, Berne:
Pregnancy
Stress, Psychological
Low Back Pain
Breech Presentation
Relaxation
Hydrotherapy
Acupressure
WATSU

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Stress, Psychological
Breech Presentation
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms
Obstetric Labor Complications
Pregnancy Complications