Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy

NCT01708018 | Completed

• 4 other identifiers: 058/12Studytyp A, Nr. 2211SAP-Fall-Nr.: 3991344SAP-Patient: 11095660
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in psychological stress

  Day 8

Secondary Outcomes (7)

• Low back pain

  Days 1, 4, 8, and weekly until birth

• Breech presentation

  Days 1, 4, 8, and weekly until birth

• Quality of Life

  Days 1, 4, 8, and weekly until birth

• Amount of amniotic fluid

  Days 1, 4, 8

• Qualitative questionnaire

  Day 4

Study Arms (2)

Control group

NO INTERVENTION

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.

Intervention group

EXPERIMENTAL

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

Interventions

WATSU PROCEDURE

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).

Intervention group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Neurological deficits resulting from low back pain
• already ongoing WATSU-treatment

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• BFH Berner Fachhochschule für Gesundheit: collaborator
• University of Bern: collaborator

Study Sites (1)

Department of Obstetrics and Gynecology, University Hospital, Inselspital, Effingerstrasse 102

Bern, Canton of Bern, 3010 Bern, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 25815033 DERIVED

Related Links

• Link to trial on the official website of the association of practitioners of WATSU in Switzerland

MeSH Terms

Conditions

Breech Presentation; Low Back Pain; Stress, Psychological

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Daniel Surbek, Prof. Dr. med.

  Department of Obstetrics and Gynecology, University Hospital Bern

  STUDY CHAIR

• Luigi Raio, PD Dr. med.

  Department of Obstetrics and Gynecology, University Hospital Bern

  STUDY DIRECTOR

• Agnes M Schitter, MSc PT

  BFH Bern University of Applied Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: October 16, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 10, 2014

Record last verified: 2014-09

Locations

CH (1)