Clinical trial NCT01708018: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Breech Presentation
Low Back Pain
Stress, Psychological
Keywords: Pregnancy
Stress, Psychological
Low Back Pain
Breech Presentation
Relaxation
Hydrotherapy
Acupressure
WATSU
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: BFH Berner Fachhochschule für Gesundheit
name: University of Bern
First posted: 2012-10-16
Enrollment: 17
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in psychological stress
timeFrame: Day 8
Secondary outcomes:
measure: Low back pain
timeFrame: Days 1, 4, 8, and weekly until birth
measure: Breech presentation
timeFrame: Days 1, 4, 8, and weekly until birth
measure: Quality of Life
timeFrame: Days 1, 4, 8, and weekly until birth
measure: Amount of amniotic fluid
timeFrame: Days 1, 4, 8
measure: Qualitative questionnaire
timeFrame: Day 4
measure: Birth (vaginal, cesarean, complications, breech)
timeFrame: after birth
measure: Psychological wellbeing
timeFrame: Days 1, 4, 8 and weekly until birth
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Obstetrics and Gynecology, University Hospital, Inselspital, Effingerstrasse 102
Study officials:
affiliation: Department of Obstetrics and Gynecology, University Hospital Bern
name: Daniel Surbek, Prof. Dr. med.
role: STUDY_CHAIR
affiliation: Department of Obstetrics and Gynecology, University Hospital Bern
name: Luigi Raio, PD Dr. med.
role: STUDY_DIRECTOR
affiliation: BFH Bern University of Applied Sciences
name: Agnes M Schitter, MSc PT
role: STUDY_DIRECTOR
References:
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.