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Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy

Pilot Study: Effects of Relaxing Hydrotherapy WATSU in Third Trimester of Pregnancy, an Explorative Cohort-Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01708018
Enrollment
17
Registered
2012-10-16
Start date
2012-07-31
Completion date
2014-05-31
Last updated
2014-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breech Presentation, Low Back Pain, Pregnancy, Stress, Psychological

Keywords

Pregnancy, Stress, Psychological, Low Back Pain, Breech Presentation, Relaxation, Hydrotherapy, Acupressure, WATSU

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.

Interventions

PROCEDUREWATSU

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).

Sponsors

BFH Berner Fachhochschule für Gesundheit
CollaboratorUNKNOWN
University of Bern
CollaboratorOTHER
Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime frame
Change from baseline in psychological stressDay 8

Secondary

MeasureTime frame
Qualitative questionnaireDay 4
Birth (vaginal, cesarean, complications, breech)after birth
Psychological wellbeingDays 1, 4, 8 and weekly until birth
Amount of amniotic fluidDays 1, 4, 8
Breech presentationDays 1, 4, 8, and weekly until birth
Quality of LifeDays 1, 4, 8, and weekly until birth
Low back painDays 1, 4, 8, and weekly until birth

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026