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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05004272
Other study ID # PMR_IOBA_01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 16, 2021
Est. completion date September 30, 2021

Study information

Verified date December 2021
Source Johannes Kepler University of Linz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Due to social isolation and increased stress factors during the COVID-19 pandemic an increase of psychological and psychosomatic complaints in the population can be observed. There is growing evidence of the importance of body awareness (BA) in these complaints. The question arises how BA can be modified through therapeutic measures. The Awareness Body Chart (ABC), an innovative non-verbal tool for investigating subjective body awareness, implemented in clinical practice brings to light astonishing findings of patients' bodily experiences which have not been collected through verbal communication so far. In a randomized controlled study with 96 healthy adults in three groups (massage, gymnastics and control group), the use of the 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 hypotheses: Primary hypothesis: There is a difference in the change of BA between the massage group and the control group, and there is a difference in the change of BA between the gymnastics group and the control group. Secondary hypothesis: There is a difference in the change of BA between the massage group and the gymnastics 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 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 Completed
Enrollment 96
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
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 make it difficult to participate in a moderate exercise while standing - Chronic diseases / impairments that make it difficult to lie prone for a massage - Current illnesses or injuries that are a contraindication for hand massages or gymnastics

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Massage
20-minute manual full-body massage
Gymnastics
20-minute moderate body workout
Other:
Lecture
20-minute lecture on medicinal herbs

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 Body Mass Index Relation of body weight to the square of body height 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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