NCT05004272

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

August 16, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

December 13, 2021

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

June 2, 2021

Last Update Submit

December 10, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Short questionnaire on self-perception of the body

    Before intervention

  • Short questionnaire on self-perception of the body

    Immediately after intervention

  • Self-rating mood scale - revised

    Before intervention

  • Self-rating mood scale - revised

    Immediately after intervention

Other Outcomes (7)

  • Simple Physical Activity Questionnaire

    Before intervention

  • Short Form Health Survey (SF-12)

    Before intervention

  • Brief Symptom Inventory

    Before intervention

  • +4 more other outcomes

Study Arms (3)

Massage

ACTIVE COMPARATOR
Procedure: Massage

Gymnastics

ACTIVE COMPARATOR
Procedure: Gymnastics

Lecture

PLACEBO COMPARATOR
Other: Lecture

Interventions

MassagePROCEDURE

20-minute manual full-body massage

Massage
GymnasticsPROCEDURE

20-minute moderate body workout

Gymnastics
LectureOTHER

20-minute lecture on medicinal herbs

Lecture

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kepler University Hospital

Linz, 4020, Austria

Location

MeSH Terms

Interventions

MassageGymnastics

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2021

First Posted

August 13, 2021

Study Start

August 16, 2021

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

December 13, 2021

Record last verified: 2021-12

Locations