IOBA - Impact on Body Awareness

Body Image Clinical Trial

— IOBA  

Official title:

Impact of Therapeutic Measures on Body Awareness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05004272
• Other study ID #: PMR_IOBA_01
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Body Image
• Perception, Self
• Self-Assessment

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