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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05769543
Other study ID # IWOBA_1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 20, 2023
Est. completion date August 1, 2023

Study information

Verified date March 2023
Source Johannes Kepler University of Linz
Contact Christian Mittermaier, M.D.
Phone +4357680836170
Email christian.mittermaier@kepleruniklinikum.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
WATSU application
20-minute application of WATSU
Other:
Lecture
20-minute lecture on WATSU technique

Locations

Country Name City State
Austria Kepler University Hospital Linz

Sponsors (2)

Lead Sponsor Collaborator
Johannes Kepler University of Linz Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Other Simple Physical Activity Questionnaire 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
Other Short Form Health Survey (SF-12) 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
Other Brief Symptom Inventory 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
Other Beck Depression Inventory II (BDI-II) 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
Other Body Mass Index Relation of body weight to the square of body height Before intervention
Other Like/Dislike Body Chart 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
Other Additional questions Questions on demographic data and chronic complaints and current illnesses Before intervention
Other Charlson Comorbidity Index Questionnaire on comorbidities Before intervention
Other Feedback form Personal feedback on questionnaires and measures Immediately after investigation
Primary Awareness Body Chart Questionnaire 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
Primary Awareness Body Chart Questionnaire 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 Short questionnaire on self-perception of the body 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
Secondary Short questionnaire on self-perception of the body 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
Secondary Self-rating mood scale - revised Verbal questionnaire concerning mood status. 24 pairs of oppositional adjectives concerning mood: One of them or Before intervention
Secondary Self-rating mood scale - revised Verbal questionnaire concerning mood status. 24 pairs of oppositional adjectives concerning mood: One of them or Immediately after intervention
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