Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy
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Purpose
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 | Intervention |
|---|---|
|
Pregnancy Breech Presentation Low Back Pain Stress, Psychological |
Procedure: WATSU |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study: Effects of Relaxing Hydrotherapy WATSU in Third Trimester of Pregnancy, an Explorative Cohort-Study |
- Change from baseline in psychological stress [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
- Low back pain [ Time Frame: Days 1, 4, 8, and weekly until birth ] [ Designated as safety issue: No ]
- Breech presentation [ Time Frame: Days 1, 4, 8, and weekly until birth ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: Days 1, 4, 8, and weekly until birth ] [ Designated as safety issue: No ]
- Amount of amniotic fluid [ Time Frame: Days 1, 4, 8 ] [ Designated as safety issue: No ]
- Qualitative questionnaire [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
- Birth (vaginal, cesarean, complications, breech) [ Time Frame: after birth ] [ Designated as safety issue: No ]
- Psychological wellbeing [ Time Frame: Days 1, 4, 8 and weekly until birth ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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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). |
Show Detailed Description Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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| Contact: Luigi Raio, PD Dr. med. | +41 (0)31 632 18 31 | luigi.raio@insel.ch |
| Contact: Agnes M Schitter, cand. MSc PT | +41 (0)76 322 77 10 | agnes.schitter@bluewin.ch |
| Switzerland | |
| Department of Obstetrics and Gynecology, University Hospital, Inselspital, Effingerstrasse 102 | Recruiting |
| Bern, Switzerland, 3010 Bern | |
| Contact: Luigi Raio, PD Dr. +41 (0)31 632 18 31 luigi.raio@insel.ch | |
| Contact: Agnes M Schitter, cand. MSc PT +41 (0)76 322 77 10 agnes.schitter@bluewin.ch | |
| Principal Investigator: Luigi Raio, PD Dr. med. | |
| Sub-Investigator: Agnes M Schitter, cand. MSc PT | |
| 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, BSc PT | BFH Bern University of Applied Sciences |
More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital Inselspital, Berne |
| ClinicalTrials.gov Identifier: | NCT01708018 History of Changes |
| Other Study ID Numbers: | 058/12, Studytyp A, Nr. 2211, SAP-Fall-Nr.: 3991344, SAP-Patient: 11095660 |
| Study First Received: | October 8, 2012 |
| Last Updated: | April 25, 2013 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University Hospital Inselspital, Berne:
|
Pregnancy Stress, Psychological Low Back Pain Breech Presentation |
Relaxation Hydrotherapy Acupressure WATSU |
Additional relevant MeSH terms:
|
Back Pain Breech Presentation Low Back Pain Stress, Psychological Pain Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Obstetric Labor Complications Pregnancy Complications Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013