Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University Hospital Inselspital, Berne
Sponsor:
Collaborators:
BFH Berner Fachhochschule für Gesundheit
KIKOM Kollegiale Instanz für Komplementärmedizin
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01708018
First received: October 8, 2012
Last updated: February 19, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study: Effects of Relaxing Hydrotherapy WATSU in Third Trimester of Pregnancy, an Explorative Cohort-Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in psychological stress [ Time Frame: Day 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Low back pain [ Time Frame: Days 1, 4, 8, and weekly until birth ] [ Designated as safety issue: No ]
  • Breech presentation [ Time Frame: Days 1, 4, 8, and weekly until birth ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Days 1, 4, 8, and weekly until birth ] [ Designated as safety issue: No ]
  • Amount of amniotic fluid [ Time Frame: Days 1, 4, 8 ] [ Designated as safety issue: No ]
  • Qualitative questionnaire [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
  • Birth (vaginal, cesarean, complications, breech) [ Time Frame: after birth ] [ Designated as safety issue: No ]
  • Psychological wellbeing [ Time Frame: Days 1, 4, 8 and weekly until birth ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708018

Contacts
Contact: Luigi Raio, PD Dr. med. +41 (0)31 632 18 31 luigi.raio@insel.ch
Contact: Agnes M Schitter, MSc PT +41 (0)76 322 77 10 agnes.schitter@bluewin.ch

Locations
Switzerland
Department of Obstetrics and Gynecology, University Hospital, Inselspital, Effingerstrasse 102 Recruiting
Bern, Switzerland, 3010 Bern
Contact: Luigi Raio, PD Dr.    +41 (0)31 632 18 31    luigi.raio@insel.ch   
Contact: Agnes M Schitter, MSc PT    +41 (0)76 322 77 10    agnes.schitter@bluewin.ch   
Principal Investigator: Luigi Raio, PD Dr. med.         
Sub-Investigator: Agnes M Schitter, MSc PT         
Sponsors and Collaborators
University Hospital Inselspital, Berne
BFH Berner Fachhochschule für Gesundheit
KIKOM Kollegiale Instanz für Komplementärmedizin
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:
No publications provided

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
Study First Received: October 8, 2012
Last Updated: February 19, 2014
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on July 29, 2014