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Completed

NCT Number: NCT05004272

IOBA - Impact on Body Awareness

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kepler University Hospital

Linz, 4020, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Massage

Procedure

20-minute manual full-body massage

Gymnastics

Procedure

20-minute moderate body workout

Lecture

Other

20-minute lecture on medicinal herbs

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Body Mass Index

    Time frame: Before intervention

    Relation of body weight to the square of body height

  5. Additional questions

    Time frame: Before intervention

    Questions on demographic data and chronic complaints and current illnesses

  6. Charlson Comorbidity Index

    Time frame: Before intervention

    Questionnaire on comorbidities

  7. Feedback form

    Time frame: Immediately after investigation

    Personal feedback on questionnaires and measures

Sponsors and collaborators

Lead sponsor

Johannes Kepler University of Linz

Other

Collaborators

  • Medical University of Graz

Registry information

Official study title

Impact of Therapeutic Measures on Body Awareness

Acronym: IOBA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2021
Registry last updated
Dec 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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