PregnancyNCT01708018
Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy
A study testing WATSU in people with Pregnancy and Breech Presentation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Breech Presentation, Low Back Pain
- What is being tested?
- WATSU
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2012to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Neurological deficits resulting from low back pain
- already ongoing WATSU-treatment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Obstetrics and Gynecology, University Hospital, Inselspital, Effingerstrasse 102
Bern, Canton of Bern, 3010 Bern
About this study
Official title: Pilot Study: Effects of Relaxing Hydrotherapy WATSU in Third Trimester of Pregnancy, an Explorative Cohort-Study
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).
Read the 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.
- Conditions
- Pregnancy, Breech Presentation, Low Back Pain, Stress, Psychological
- Being tested
- WATSU
- Keywords
- Pregnancy, Stress, Psychological, Low Back Pain, Breech Presentation, Relaxation, Hydrotherapy, Acupressure, WATSU
- Medical subject headings
- Breech Presentation, Low Back Pain, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WATSUProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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. |
| Intervention group | Experimental | 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. Receives: Procedure: WATSU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in psychological stress
Measured: Day 8
Secondary outcomes (7)
Low back pain
Measured: Days 1, 4, 8, and weekly until birth
Breech presentation
Measured: Days 1, 4, 8, and weekly until birth
Quality of Life
Measured: Days 1, 4, 8, and weekly until birth
Amount of amniotic fluid
Measured: Days 1, 4, 8
Qualitative questionnaire
Measured: Day 4
Birth (vaginal, cesarean, complications, breech)
Measured: after birth
Psychological wellbeing
Measured: Days 1, 4, 8 and weekly until birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Bern University of Applied Sciences, University of Bern
- Responsible party
- Sponsor
- Investigators
- Daniel Surbek, Prof. Dr. med., Study chair, Department of Obstetrics and Gynecology, University Hospital BernLuigi Raio, PD Dr. med., Study director, Department of Obstetrics and Gynecology, University Hospital BernAgnes M Schitter, MSc PT, Study director, BFH Bern University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708018
- Sponsor's protocol ID
- 058/12
- Other IDs
- Studytyp A, Nr. 2211, SAP-Fall-Nr.: 3991344, SAP-Patient: 11095660
- Status last verified
- Sep 2014
- First submitted
- 8 Oct 2012
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25815033
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Effects of Relaxing Hydrotherapy WATSU in Third Trimester of Pregnancy, an Explorative Cohort-Study
- ClinicalTrials.gov ID
- NCT01708018
- Acronym / sponsor ID
- 058/12
- Conditions
- Pregnancy, Breech Presentation, Low Back Pain, Stress, Psychological
- Keywords
- Pregnancy, Stress, Psychological, Low Back Pain, Breech Presentation, Relaxation, Hydrotherapy, Acupressure, WATSU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Bern University of Applied Sciences, University of Bern
- Study start
- Jul 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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. |
| Intervention group | Experimental | Procedure: WATSUPrior 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy women
- singleton pregnancy
- without pathological findings
- at week of gestation >36+0
- fluent German
Key exclusion criteria (2 listed)
- Neurological deficits resulting from low back pain
- already ongoing WATSU-treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WATSUWATSU (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). | Procedure or surgery | Intervention group |
Primary outcome
Change from baseline in psychological stress
Time frame: Day 8
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2014.
- Derived from this study: PubMed 25815033Schitter 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.
- Link to trial on the official website of the association of practitioners of WATSU in SwitzerlandLink provided by the sponsor.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Surbek, Prof. Dr. med. study chair
Department of Obstetrics and Gynecology, University Hospital Bern
Luigi Raio, PD Dr. med. study director
Department of Obstetrics and Gynecology, University Hospital Bern
Agnes M Schitter, MSc PT study director
BFH Bern University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WATSU in people with Pregnancy and Breech Presentation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in psychological stress (time frame: Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01708018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2014.