IOBA - Impact on Body Awareness

Sponsor
Johannes Kepler University of Linz (Other)
Overall Status
Completed
CT.gov ID
NCT05004272
Collaborator
Medical University of Graz (Other)
96
1
3
1.5
64.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Massage
  • Procedure: Gymnastics
  • Other: Lecture
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Impact of Therapeutic Measures on Body Awareness
Actual Study Start Date :
Aug 16, 2021
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Massage

Procedure: Massage
20-minute manual full-body massage

Active Comparator: Gymnastics

Procedure: Gymnastics
20-minute moderate body workout

Placebo Comparator: Lecture

Other: Lecture
20-minute lecture on medicinal herbs

Outcome Measures

Primary Outcome Measures

  1. Awareness Body Chart Questionnaire [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.

  2. Awareness Body Chart Questionnaire [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.

Secondary Outcome Measures

  1. Short questionnaire on self-perception of the body [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.

  2. Short questionnaire on self-perception of the body [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.

  3. Self-rating mood scale - revised [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.

  4. Self-rating mood scale - revised [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.

Other Outcome Measures

  1. Simple Physical Activity Questionnaire [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.

  2. Short Form Health Survey (SF-12) [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.

  3. Brief Symptom Inventory [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.

  4. Body Mass Index [Before intervention]

    Relation of body weight to the square of body height

  5. Additional questions [Before intervention]

    Questions on demographic data and chronic complaints and current illnesses

  6. Charlson Comorbidity Index [Before intervention]

    Questionnaire on comorbidities

  7. Feedback form [Immediately after investigation]

    Personal feedback on questionnaires and measures

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kepler University Hospital Linz Austria 4020

Sponsors and Collaborators

  • Johannes Kepler University of Linz
  • Medical University of Graz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johannes Kepler University of Linz
ClinicalTrials.gov Identifier:
NCT05004272
Other Study ID Numbers:
  • PMR_IOBA_01
First Posted:
Aug 13, 2021
Last Update Posted:
Dec 13, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 13, 2021