Vocal Intervention in Systemic Sclerosis

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02821663

Enrollment

Registered

2016-07-01

Start date

2014-11-30

Completion date

2018-02-28

Last updated

2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

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.

Interventions

BEHAVIORALvocal intervention

10 x 60 min. sessions of vocal intervention

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Austria

Contacts

Primary ContactMichael Mickel, MD

michael.mickel@meduniwien.ac.at

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026