Perception, SelfIOBANCT05004272
IOBA - Impact on Body Awareness
A study testing Massage, Gymnastics and Lecture in people with Perception, Self and Body Image, run by Johannes Kepler University of Linz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Perception, Self, Body Image, Self-Assessment
- What is being tested?
- Massage, Gymnastics and Lecture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteAustria
- Study dates
- 16 Aug 2021to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Therapeutic Measures 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.
- Conditions
- Perception, Self, Body Image, Self-Assessment
- Being tested
- Massage, Gymnastics, Lecture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageProcedure or surgery
20-minute manual full-body massage
GymnasticsProcedure or surgery
20-minute moderate body workout
LectureOther
20-minute lecture on medicinal herbs
| Study group | Role | What they receive |
|---|---|---|
| Massage | Active comparator | Not described Receives: Procedure: Massage |
| Gymnastics | Active comparator | Not described Receives: Procedure: Gymnastics |
| Lecture | Placebo comparator | Not described Receives: Other: Lecture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before intervention
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.
Measured: Immediately after intervention
Secondary outcomes (4)
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.
Measured: Before intervention
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.
Measured: Immediately after intervention
Self-rating mood scale - revised
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.
Measured: Before intervention
Self-rating mood scale - revised
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.
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start16 Aug 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perception, SelfStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004272
- Sponsor's protocol ID
- PMR_IOBA_01
- Acronym
- IOBA
- Status last verified
- Dec 2021
- First submitted
- 2 Jun 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Therapeutic Measures on Body Awareness
- ClinicalTrials.gov ID
- NCT05004272
- Acronym / sponsor ID
- IOBA / PMR_IOBA_01
- Conditions
- Perception, Self, Body Image, Self-Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Collaborators
- Medical University of Graz
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Massage | Active comparator | Procedure: Massage |
| Gymnastics | Active comparator | Procedure: Gymnastics |
| Lecture | Placebo comparator | Other: Lecture |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage20-minute manual full-body massage | Procedure or surgery | Massage |
| Gymnastics20-minute moderate body workout | Procedure or surgery | Gymnastics |
| Lecture20-minute lecture on medicinal herbs | Other | Lecture |
Primary outcome
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.
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.
4 secondary outcomes
Short questionnaire on self-perception of the body
Time frame: Before intervention
Short questionnaire on self-perception of the body
Time frame: Immediately after intervention
Self-rating mood scale - revised
Time frame: Before intervention
Self-rating mood scale - revised
Time frame: Immediately after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage, Gymnastics and Lecture in people with Perception, Self and Body Image, run by Johannes Kepler University of Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Awareness Body Chart Questionnaire (time frame: Before intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.