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Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy

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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

Tracking Information
First Submitted Date  ICMJE October 8, 2012
First Posted Date  ICMJE October 16, 2012
Last Update Posted Date September 10, 2014
Study Start Date  ICMJE July 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2012)
Change from baseline in psychological stress [ Time Frame: Day 8 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2012)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy
Official Title  ICMJE 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pregnancy
  • Breech Presentation
  • Low Back Pain
  • Stress, Psychological
Intervention  ICMJE 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).

Study Arms  ICMJE
  • 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.
    Intervention: Procedure: WATSU
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2014)
17
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2012)
45
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01708018
Other Study ID Numbers  ICMJE 058/12
Studytyp A, Nr. 2211
SAP-Fall-Nr.: 3991344
SAP-Patient: 11095660
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE
  • BFH Berner Fachhochschule für Gesundheit
  • University of Bern
Investigators  ICMJE
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
PRS Account University Hospital Inselspital, Berne
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP