Vocal Intervention in Systemic Sclerosis

Not Applicable

• Conditions: Systemic Sclerosis
• Interventions: Behavioral: vocal intervention

• Registration Number: NCT02821663
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-13
• Primary Completion: 2017-10
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• positive criteria for Systemic Sclerosis according to the American College of Rheumatology/European League Against Rheumatism

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Exclusion Criteria

• affection of the vocal apparatus
• dyspnea at rest
• oxygen prescription

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vocal intervention	vocal intervention	Vocal intervention

Primary Outcome Measures

Name	Time	Method
MOS 36-Item Short Form Health Survey	up to 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Secretory immunoglobulin A; mg/l	up to 4 weeks	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.
6-minutes walk test	up to 4 weeks	The 6-minute walk test assess changes in functional exercise capacity with the primary outcome reported being the distance walked during the test.
Mouth open; in millimeter	up to 4 weeks	incisor to incisor; corner of mouth to corner of mouth; measurement by tape
Saliva cortisol; ng/ml	up to 4 weeks	Cortisol is a steroid hormone indicating changes in stress status. Collected by a swab placed in the mouth.

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, Medical University of Vienna; 🇦🇹 Vienna, Austria