Vocal Intervention in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

Official title:

Rehabilitation in Patients Suffering From Systemic Sclerosis by Vocal Intervention: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02821663
• Other study ID #: SSc-1-MM
• Status: Recruiting
• Phase: N/A
• First received: June 24, 2016
• Last updated: April 12, 2017
• Start date: November 2014
• Est. completion date: February 2018

Study information

• Verified date: April 2017
• Source: Medical University of Vienna
• Contact: Michael Mickel, MD
• Email: michael.mickel[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• affection of the vocal apparatus

• dyspnea at rest

• oxygen prescription

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Behavioral:
• vocal intervention
10 x 60 min. sessions of vocal intervention

Locations

Country	Name	City	State
Austria	Department of Physical Medicine and Rehabilitation, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Mouth open; in millimeter	incisor to incisor; corner of mouth to corner of mouth; measurement by tape	up to 4 weeks
Secondary	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.	up to 4 weeks
Secondary	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
Secondary	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