- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05769543
WATSU and Body Awareness (IWOBA)
Impact of WATSU on Body Awareness
Body awareness (BA) is an essential factor for health and well-being. In 2021, the IOBA (Impact on Body Awareness) study was conducted at the Institute of Physical Medicine & Rehabilitation at Kepler University Hospital. Thereby, the impact of massage and of gymnastics on BA in healthy individuals was surveyed. The protocol provides a solid basis for further research projects on BA. In the present study, the direct effect of a WATSU® (Shiatsu in Water) application on BA as well as on the state of health of healthy persons will be determined and BA will be further investigated.
In a randomized controlled study with 60 healthy adults in two groups (WATSU and control group), the use of the Awareness Body Chart (ABC) questionnaire and further German questionnaires (Short questionnaire on self-perception of the body, self-rating mood scale - revised) concerning body awareness and well-being should analyse the following hypothesis: There is a difference in the change of BA between the WATSU group and the control group. Before interventions demographic data and further questionnaires concerning health conditions of the participants (Simple Physical Activity Questionnaire, Short Form Health Survey, Brief Symptom Inventory, Like/Dislike Body Chart and additional questions) are administered. Correlations between BA and the results of these tests will be investigated too. All these analyses can provide innovative information about BA and be indicative in the use of physiotherapeutic measures.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christian Mittermaier, M.D.
- Phone Number: +4357680836170
- Email: [email protected]
Study Locations
-
Austria
-
-
Linz, Austria, 4020
- Recruiting
- Kepler University Hospital
-
Contact:
- Christian Mittermaier, M.D.
- Email: [email protected]
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy volunteers
- Signing of informed consent by participants and head of the study
- Understanding of German language in order to be able to follow a lecture and complete questionnaires
Exclusion Criteria:
- Current sick leave
- Pregnancy
- Acute physical or psychological complaints on the day of study participation
- Chronic illnesses / disabilities which contraindicate participation or make it difficult to use the therapy pool
- Current illnesses or injuries
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
|
20-minute lecture on WATSU technique
|
Active Comparator: WATSU application
|
20-minute application of WATSU
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Awareness Body Chart Questionnaire
Time Frame: Before intervention
|
Body charts to fill in with colours according to intensity of body awareness.
In sum, 51 body regions to colour with 5 different colour pencils (orange = "I can perceive with much detail", yellow = "I can perceive distinctly", green = "I can perceive", blue = "I can perceive indistinctly", black = "I cannot perceive").
To quantify the information, every region of the body will be coded as an extra item and the data of the colours will be transcribed: orange (= 5), yellow (= 4), green (= 3), blue (= 2), black (= 1).
Higher values mean higher intensity of body awareness.
|
Before intervention
|
Awareness Body Chart Questionnaire
Time Frame: Immediately after intervention
|
Body charts to fill in with colours according to intensity of body awareness.
In sum, 51 body regions to colour with 5 different colour pencils (orange = "I can perceive with much detail", yellow = "I can perceive distinctly", green = "I can perceive", blue = "I can perceive indistinctly", black = "I cannot perceive").
To quantify the information, every region of the body will be coded as an extra item and the data of the colours will be transcribed: orange (= 5), yellow (= 4), green (= 3), blue (= 2), black (= 1).
Higher values mean higher intensity of body awareness.
|
Immediately after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short questionnaire on self-perception of the body
Time Frame: Before intervention
|
Verbal questionnaire concerning body awareness.
20 items (5 = "I can perceive with much detail", 4 = "I can perceive distinctly", 3 = "I can perceive", 2 = "I can perceive indistinctly", 1 = "I cannot perceive").
Higher values mean higher intensity of body awareness.
|
Before intervention
|
Short questionnaire on self-perception of the body
Time Frame: Immediately after intervention
|
Verbal questionnaire concerning body awareness.
20 items (5 = "I can perceive with much detail", 4 = "I can perceive distinctly", 3 = "I can perceive", 2 = "I can perceive indistinctly", 1 = "I cannot perceive").
Higher values mean higher intensity of body awareness.
|
Immediately after intervention
|
Self-rating mood scale - revised
Time Frame: Before intervention
|
Verbal questionnaire concerning mood status.
24 pairs of oppositional adjectives concerning mood: One of them or <neither nor> should be ticked, depending on how it best corresponds to the current situation.
The negative pole = 2.
The positive pole = 0. <neither nor> = 1.
Higher sum scores indicate worse subjective mood, lower values better mood.
|
Before intervention
|
Self-rating mood scale - revised
Time Frame: Immediately after intervention
|
Verbal questionnaire concerning mood status.
24 pairs of oppositional adjectives concerning mood: One of them or <neither nor> should be ticked, depending on how it best corresponds to the current situation.
The negative pole = 2.
The positive pole = 0. <neither nor> = 1.
Higher sum scores indicate worse subjective mood, lower values better mood.
|
Immediately after intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Simple Physical Activity Questionnaire
Time Frame: Before intervention
|
Questionnaire to survey physical activity: It should show a snapshot of hours per day of an average day in the past week.
The time in bed, the time while doing sedentary work (including dozing), while walking, while exercising and during other physical activities (such as household chores) is interrogated.
The test does not measure the intensity of physical activity, but rather sorts it into the groups walking, sport and other categories.
|
Before intervention
|
Short Form Health Survey (SF-12)
Time Frame: Before intervention
|
Questionnaire on health-related quality of life.
It consists of twelve questions relating to the last four weeks and yields statements about eight different dimensions of subjective health: general health perception, physical health, physically-conditioned role function, physical pain, vitality, mental health, emotionally-related role function, social functionality.
Different Likert-Scales are used.
A physical sum scale and a psychological sum scale can be calculated.
The polarity of four items must be reversed so that higher values in all items and total scales reflect a better state of health.
Normative data are available.
|
Before intervention
|
Brief Symptom Inventory
Time Frame: Before intervention
|
Questionnaire on the burden of symptoms.
The BSI is also called the Brief Symptom Check List (BSCL), it is a short form of the SCL-90 (Derogatis, 1993).
The BSI consists of 53 items (physical as well as psychological symptoms), which are assessed subjectively on a Likert scale in relation to the last seven days from 0 = "not at all" to 5 = "very strong".
The items result in nine scales: somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism.
|
Before intervention
|
Body Mass Index
Time Frame: Before intervention
|
Relation of body weight to the square of body height
|
Before intervention
|
Additional questions
Time Frame: Before intervention
|
Questions on demographic data and chronic complaints and current illnesses
|
Before intervention
|
Charlson Comorbidity Index
Time Frame: Before intervention
|
Questionnaire on comorbidities
|
Before intervention
|
Feedback form
Time Frame: Immediately after investigation
|
Personal feedback on questionnaires and measures
|
Immediately after investigation
|
Beck Depression Inventory II (BDI-II)
Time Frame: Before intervention
|
The BDI-II represents a self-rating instrument to assess the severity of depression.
Four statements are given for each of 21 questions, from which the one that best describes how the person has felt in the past week is to be selected.
In scoring, each item is given a score of 0 to 3, depending on the choice (higher number means higher depression scores), and after directly adding the scores of the individual items, a total score of 0 to 63 is obtained.
|
Before intervention
|
Like/Dislike Body Chart
Time Frame: Before intervention
|
As an extension to the ABC, this questionnaire is intended to answer the question of whether there are areas of the body that one particularly likes about oneself or that one dislikes about oneself.
If yes, one can draw these with a purple color pencil ("particularly like") and/or with a gray color pencil ("do not like") in an extra Body Chart.
|
Before intervention
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IWOBA_1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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