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Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy

Primary Purpose

Pregnancy, Breech Presentation, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
WATSU
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy focused on measuring Pregnancy, Stress, Psychological, Low Back Pain, Breech Presentation, Relaxation, Hydrotherapy, Acupressure, WATSU

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Obstetrics and Gynecology, University Hospital, Inselspital, Effingerstrasse 102

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in psychological stress

Secondary Outcome Measures

Low back pain
Breech presentation
Quality of Life
Amount of amniotic fluid
Qualitative questionnaire
Birth (vaginal, cesarean, complications, breech)
Psychological wellbeing

Full Information

First Posted
October 8, 2012
Last Updated
September 9, 2014
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
BFH Berner Fachhochschule für Gesundheit, University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT01708018
Brief Title
Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy
Official Title
Pilot Study: Effects of Relaxing Hydrotherapy WATSU in Third Trimester of Pregnancy, an Explorative Cohort-Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
BFH Berner Fachhochschule für Gesundheit, University of Bern

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Breech Presentation, Low Back Pain, Stress, Psychological
Keywords
Pregnancy, Stress, Psychological, Low Back Pain, Breech Presentation, Relaxation, Hydrotherapy, Acupressure, WATSU

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm 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 Title
Intervention group
Arm Type
Experimental
Arm 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(s)
WATSU
Intervention 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).
Primary Outcome Measure Information:
Title
Change from baseline in psychological stress
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Low back pain
Time Frame
Days 1, 4, 8, and weekly until birth
Title
Breech presentation
Time Frame
Days 1, 4, 8, and weekly until birth
Title
Quality of Life
Time Frame
Days 1, 4, 8, and weekly until birth
Title
Amount of amniotic fluid
Time Frame
Days 1, 4, 8
Title
Qualitative questionnaire
Time Frame
Day 4
Title
Birth (vaginal, cesarean, complications, breech)
Time Frame
after birth
Title
Psychological wellbeing
Time Frame
Days 1, 4, 8 and weekly until birth

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Surbek, Prof. Dr. med.
Organizational Affiliation
Department of Obstetrics and Gynecology, University Hospital Bern
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luigi Raio, PD Dr. med.
Organizational Affiliation
Department of Obstetrics and Gynecology, University Hospital Bern
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Agnes M Schitter, MSc PT
Organizational Affiliation
BFH Bern University of Applied Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, University Hospital, Inselspital, Effingerstrasse 102
City
Bern
ZIP/Postal Code
3010 Bern
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25815033
Citation
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.
Results Reference
derived
Links:
URL
http://www.iaka.ch/studien
Description
Link to trial on the official website of the association of practitioners of WATSU in Switzerland

Learn more about this trial

Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy

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