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

Sponsor:

Collaborators:

BFH Berner Fachhochschule für Gesundheit

University of Bern

Information provided by (Responsible Party):

University Hospital Inselspital, Berne

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Pregnancy Breech Presentation Low Back Pain Stress, Psychological	Procedure: WATSU	Not Applicable

Show detailed description

Detailed Description:

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 child's position is being suggested although associated with risks for mother and child. Breech presentations are the most frequent medical indication for cesarean sections.

The impacts of stress on unborn children are being investigated, long-term effects are being speculated.

Objective

In contrast to active hydrotherapy, passive hydrotherapy was not yet subject of investigation concerning its effects during pregnancy. The goals of this pilot-study are:

To evaluate the effects of passive hydrotherapy WATSU in the third trimester of pregnancy by the means of a scientific prospective approach and to ascertain, whether the reported effects can be observed under such conditions
To evaluate the therapeutic potential of WATSU
To evaluate the usefulness, feasibility and framework requirements of further RCT addressing this issue
To evaluate, whether or not - which of, respectively - the chosen parameter are suitable for further investigations (RCT)
To evaluate potential for improvement in study design and management.

Methods

Design: pilot-study, explorative comparison of two cohorts. Criterion for pseudorandomisation: immersion contraindicated (e.g. due to perforation of the eardrum). Recruitment from July to December 2012; expected participants: 45.

Parameter: ultrasound examination of position of the fetus and amount of amniotic fluid; qualitative and quantitative questionnaires, birth outcome (vaginal, cesarean, complications, breech presentation).

Statistics: SPSS; significance at p<.05, Intention to Treat.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	17 participants
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
Study Start Date :	July 2012
Actual Primary Completion Date :	May 2014
Actual Study Completion Date :	May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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).

Arm

Intervention/treatment

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).

Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	Child, Adult, Older Adult
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

Layout table for location information

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

Layout table for investigator information

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:

Link to trial on the official website of the association of practitioners of WATSU in Switzerland This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schitter AM, Nedeljkovic M, Baur H, Fleckenstein J, Raio L. Effects of Passive Hydrotherapy WATSU (WaterShiatsu) in the Third Trimester of Pregnancy: Results of a Controlled Pilot Study. Evid Based Complement Alternat Med. 2015;2015:437650. doi: 10.1155/2015/437650. Epub 2015 Mar 1.

Layout table for additonal information

Responsible Party:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT01708018
Other Study ID Numbers:	058/12 Studytyp A, Nr. 2211 SAP-Fall-Nr.: 3991344 SAP-Patient: 11095660
First Posted:	October 16, 2012 Key Record Dates
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:

Layout table for MeSH terms

Breech Presentation Back Pain Low Back Pain Stress, Psychological Pain	Neurologic Manifestations Behavioral Symptoms Obstetric Labor Complications Pregnancy Complications

To Top