<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01708018</url>
  </required_header>
  <id_info>
    <org_study_id>058/12</org_study_id>
    <secondary_id>Studytyp A, Nr. 2211</secondary_id>
    <secondary_id>SAP-Fall-Nr.: 3991344</secondary_id>
    <secondary_id>SAP-Patient: 11095660</secondary_id>
    <nct_id>NCT01708018</nct_id>
  </id_info>
  <brief_title>Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy</brief_title>
  <official_title>Pilot Study: Effects of Relaxing Hydrotherapy WATSU in Third Trimester of Pregnancy, an Explorative Cohort-Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>BFH Berner Fachhochschule für Gesundheit</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be the first scientific approach to investigate physical and psychological&#xD;
      effects of the passive hydrotherapy-method WATSU (WaterShiatsu) on women and their unborn&#xD;
      children at the third trimester of pregnancy. Potential therapeutic benefits of the method&#xD;
      shall be evaluated.&#xD;
&#xD;
      It is being hypothesized that WATSU is related to measurable changes in everyday stress&#xD;
      perception, psychological wellbeing, quality of life, pregnancy-related low back pain, tonus&#xD;
      of the uterus, amount of amniotic fluid, spontaneous course of breech presentations,&#xD;
      prospects of external cephalic versions.&#xD;
&#xD;
      Participants in the intervention-group will be treated twice with WATSU (60 minutes per&#xD;
      treatment, standardized sequence) in the &gt;36th week of pregnancy. There will not be any&#xD;
      sham-intervention in the control-group. Both groups will be examined by ultrasound (prior and&#xD;
      after the treatments plus on day 8 of the trial) and answer questionnaires (prior and after&#xD;
      the treatments plus once a week until birth).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      Within the last 20 years, evidence supporting harmlessness and benefits of hydrotherapy&#xD;
      during pregnancy accumulated. Water gymnastics were observed to have pain-relieving effects,&#xD;
      as was birth in water.&#xD;
&#xD;
      WATSU is an acronym, based on the terms Water and Shiatsu. It is a relaxing form of&#xD;
      hydrotherapy which is performed in 35° C (95° F). Practitioners claim WATSU to lower muscular&#xD;
      tonus as well as stress and to relief pain. Clinically relevant regulation of muscular tonus&#xD;
      in spastic hemiparetic patients due to WATSU was observed by Chon; significant reduction of&#xD;
      pain in patients suffering fibromyalgia by Faull.&#xD;
&#xD;
      In respect of pregnancy, WATSU is narrated - yet not scientifically evaluated - to reduce&#xD;
      pregnancy-related low back pain, to relax hypertonic muscles including those of the uterus,&#xD;
      to improve the overall sense of wellbeing and deepen the relationship of the mother to her&#xD;
      unborn child. In addition, spontaneous cephalic versions of children in breech presentations&#xD;
      within 1 to 4 days and nights following WATSU-treatments are being claimed.&#xD;
&#xD;
      According to Pennick &amp; Young, two of three pregnant women are suffering pregnancy-related low&#xD;
      back pain. Since this population is recommended to refrain from analgesic medications,&#xD;
      potentially helpful interventions ought to be identified.&#xD;
&#xD;
      The described effects of WATSU on muscle tone might be of interest in case of breech&#xD;
      presentations. Tension of the uterus has major influence on the success of attempts of&#xD;
      external cephalic version. Although breech presentation occurs in 3-4% of pregnancies only,&#xD;
      this complication is a threat to the mothers as well as the infants life. External cephalic&#xD;
      version to correct the child's position is being suggested although associated with risks for&#xD;
      mother and child. Breech presentations are the most frequent medical indication for cesarean&#xD;
      sections.&#xD;
&#xD;
      The impacts of stress on unborn children are being investigated, long-term effects are being&#xD;
      speculated.&#xD;
&#xD;
      Objective&#xD;
&#xD;
      In contrast to active hydrotherapy, passive hydrotherapy was not yet subject of investigation&#xD;
      concerning its effects during pregnancy. The goals of this pilot-study are:&#xD;
&#xD;
        -  To evaluate the effects of passive hydrotherapy WATSU in the third trimester of&#xD;
           pregnancy by the means of a scientific prospective approach and to ascertain, whether&#xD;
           the reported effects can be observed under such conditions&#xD;
&#xD;
        -  To evaluate the therapeutic potential of WATSU&#xD;
&#xD;
        -  To evaluate the usefulness, feasibility and framework requirements of further RCT&#xD;
           addressing this issue&#xD;
&#xD;
        -  To evaluate, whether or not - which of, respectively - the chosen parameter are suitable&#xD;
           for further investigations (RCT)&#xD;
&#xD;
        -  To evaluate potential for improvement in study design and management.&#xD;
&#xD;
      Methods&#xD;
&#xD;
      Design: pilot-study, explorative comparison of two cohorts. Criterion for&#xD;
      pseudorandomisation: immersion contraindicated (e.g. due to perforation of the eardrum).&#xD;
      Recruitment from July to December 2012; expected participants: 45.&#xD;
&#xD;
      Parameter: ultrasound examination of position of the fetus and amount of amniotic fluid;&#xD;
      qualitative and quantitative questionnaires, birth outcome (vaginal, cesarean, complications,&#xD;
      breech presentation).&#xD;
&#xD;
      Statistics: SPSS; significance at p&lt;.05, Intention to Treat.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in psychological stress</measure>
    <time_frame>Day 8</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Low back pain</measure>
    <time_frame>Days 1, 4, 8, and weekly until birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breech presentation</measure>
    <time_frame>Days 1, 4, 8, and weekly until birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Days 1, 4, 8, and weekly until birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of amniotic fluid</measure>
    <time_frame>Days 1, 4, 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative questionnaire</measure>
    <time_frame>Day 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth (vaginal, cesarean, complications, breech)</measure>
    <time_frame>after birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological wellbeing</measure>
    <time_frame>Days 1, 4, 8 and weekly until birth</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Pregnancy</condition>
  <condition>Breech Presentation</condition>
  <condition>Low Back Pain</condition>
  <condition>Stress, Psychological</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>WATSU</intervention_name>
    <description>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.&#xD;
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 &quot;energy-flow&quot; in the so called &quot;meridians&quot; (energy-channels) of Traditional Chinese Medicine. These &quot;meridians&quot; 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.&#xD;
During the study, each participant in the intervention group will be treated twice with WATSU (60min treatment at day 1 and 4).</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy women&#xD;
&#xD;
          -  singleton pregnancy&#xD;
&#xD;
          -  without pathological findings&#xD;
&#xD;
          -  at week of gestation &gt;36+0&#xD;
&#xD;
          -  fluent German&#xD;
&#xD;
          -  Pregnancy related low back pain&#xD;
&#xD;
          -  breech presentation&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Neurological deficits resulting from low back pain&#xD;
&#xD;
          -  already ongoing WATSU-treatment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Surbek, Prof. Dr. med.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Obstetrics and Gynecology, University Hospital Bern</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luigi Raio, PD Dr. med.</last_name>
    <role>Study Director</role>
    <affiliation>Department of Obstetrics and Gynecology, University Hospital Bern</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Agnes M Schitter, MSc PT</last_name>
    <role>Study Director</role>
    <affiliation>BFH Bern University of Applied Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, University Hospital, Inselspital, Effingerstrasse 102</name>
      <address>
        <city>Bern</city>
        <zip>3010 Bern</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://www.iaka.ch/studien</url>
    <description>Link to trial on the official website of the association of practitioners of WATSU in Switzerland</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Stress, Psychological</keyword>
  <keyword>Low Back Pain</keyword>
  <keyword>Breech Presentation</keyword>
  <keyword>Relaxation</keyword>
  <keyword>Hydrotherapy</keyword>
  <keyword>Acupressure</keyword>
  <keyword>WATSU</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breech Presentation</mesh_term>
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01708018
org study id: 058/12
secondary id: Studytyp A, Nr. 2211
secondary id: SAP-Fall-Nr.: 3991344
secondary id: SAP-Patient: 11095660
nct id: NCT01708018
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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).
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in psychological stress
time frame: Day 8
measure: Low back pain
time frame: Days 1, 4, 8, and weekly until birth
measure: Breech presentation
time frame: Days 1, 4, 8, and weekly until birth
measure: Quality of Life
time frame: Days 1, 4, 8, and weekly until birth
measure: Amount of amniotic fluid
time frame: Days 1, 4, 8
measure: Qualitative questionnaire
time frame: Day 4
measure: Birth (vaginal, cesarean, complications, breech)
time frame: after birth
measure: Psychological wellbeing
time frame: Days 1, 4, 8 and weekly until birth
arm group label: Control group
arm group type: No Intervention
description: 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.
arm group label: Intervention group
arm group type: Experimental
description: 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 type: Procedure
intervention name: WATSU
description: 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 group label: Intervention group
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Surbek, Prof. Dr. med.
role: Study Chair
affiliation: Department of Obstetrics and Gynecology, University Hospital Bern
last name: Luigi Raio, PD Dr. med.
role: Study Director
affiliation: Department of Obstetrics and Gynecology, University Hospital Bern
last name: Agnes M Schitter, MSc PT
role: Study Director
affiliation: BFH Bern University of Applied Sciences
facility: 
country: Switzerland
url: http://www.iaka.ch/studien
description: Link to trial on the official website of the association of practitioners of WATSU in Switzerland
responsible party type: Sponsor
mesh term: Breech Presentation
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Stress, Psychological