Pregnancy Clinical Trial
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).
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
| Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
| Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
| Enrolling by invitation |
NCT05415371 -
Persistent Poverty Counties Pregnant Women With Medicaid
|
N/A | |
| Completed |
NCT04548102 -
Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman
|
N/A | |
| Completed |
NCT03218956 -
Protein Requirement During Lactation
|
N/A | |
| Completed |
NCT02191605 -
Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy
|
N/A | |
| Completed |
NCT02223637 -
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
|
||
| Recruiting |
NCT06049953 -
Maternal And Infant Antipsychotic Study
|
||
| Completed |
NCT02577536 -
PregSource: Crowdsourcing to Understand Pregnancy
|
||
| Not yet recruiting |
NCT06336434 -
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05412238 -
Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months
|
N/A | |
| Not yet recruiting |
NCT04786587 -
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
|
||
| Not yet recruiting |
NCT05028387 -
Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
|
||
| Completed |
NCT02783170 -
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
|
Phase 4 | |
| Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 | |
| Recruiting |
NCT02619188 -
Nutritional Markers in Normal and Hyperemesis Pregnancies
|
N/A | |
| Recruiting |
NCT02507180 -
Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
|
||
| Recruiting |
NCT02564250 -
Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
|
N/A | |
| Completed |
NCT02523755 -
Evaluation of Regional Distribution of Ventilation During Labor With or Without Epidural Analgesia
|
Phase 4 |