Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-02-27 @ 7:06 PM
Study NCT ID:
NCT01708018
Status:
COMPLETED
Last Update Posted:
2014-09-10
First Post:
2012-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy
Sponsor:
Insel Gruppe AG, University Hospital Bern
Organization:
Study Overview
Official Title:
Pilot Study: Effects of Relaxing Hydrotherapy WATSU in Third Trimester of Pregnancy, an Explorative Cohort-Study
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: