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Systemic sclerosis is a systemic connective tissue disease with physical and mental disturbances. Based on a pilot study the feasibility and effectiveness of a novel, self-developed concept of vocal intervention in Systemic Sclerosis under vocal pedagogical guidance and music therapy is assessed.
This concept aims at functional improvement of respiration and mouth-opening, enhancement of Quality of Life, and reduction of stress carried out by a music therapist and singer with pedagogical formation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vocal intervention | Experimental | Vocal intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vocal intervention | Behavioral | 10 x 60 min. sessions of vocal intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| MOS 36-Item Short Form Health Survey | The SF-36 - a patient-reported survey of patient health - consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mouth open; in millimeter | incisor to incisor; corner of mouth to corner of mouth; measurement by tape | up to 4 weeks |
| 6-minutes walk test | The 6-minute walk test assess changes in functional exercise capacity with the primary outcome reported being the distance walked during the test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Mickel, MD | Contact | michael.mickel@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Michael Mickel, MD | Deptartment of Physical Medicine and Rehabilitation, MUW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Medicine and Rehabilitation, Medical University of Vienna | Recruiting | Vienna | A-1090 | Austria |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| up to 4 weeks |
| Secretory immunoglobulin A; mg/l | Immunoglobulin A is an antibody that plays a role in immune function in the mucous membranes. Indicates changes in immune status. Collected by a swab placed in the mouth. | up to 4 weeks |
| Saliva cortisol; ng/ml | Cortisol is a steroid hormone indicating changes in stress status. Collected by a swab placed in the mouth. | up to 4 weeks |