Adaptation and Validation of the Italian Singing Voice Handicap Index-10 (SVHI-10-IT) (Validation of I-SVHI)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41470
• EU PAS number:
  EUPAS41469
• Study ID:
  41470
• Official title and acronym:
  Adaptation and Validation of the Italian Singing Voice Handicap Index-10 (SVHI-10-IT) (Validation of I-SVHI)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  The purposes of this study were to adapt and validate the Italian version of the Singing Voice Handicap Index-10 (SVHI-10-IT) and to determine the cut-off value using videolaryngostroboscopy diagnoses as external criteria. This observational cross-sectional single-center study was conducted in the ENT and Phoniatric private Center of Pisa, Italy. Singers were included from different music genres (Contemporary Commercial Music and Classic) and from a range of experience levels (singing student, amateur or professional). A total of ninety-nine Italian singers who arrived consecutively in the private ENT and Phoniatric Center, were enrolled in the study. The singers showed up at the Center for a voice disorder or for screening. Overall, participants had a mean age of 29.8 yrs (sd 9.7, range 18-54 yrs). All subjects underwent Videolaryngostroboscopic examination and were asked to fill out the self-reported 10-item SVHI-10-IT. Laryngostroboscopic examination was pathological in 56 subjects (study group) (56/99, 56.6%), while it was normal in the remaining 43 singers (control group) (43/99, 43.4%). To confirm test-retest reliability of the SVHI-10-IT, patients were invited to complete the questionnaire for a second time, approximately 2 weeks after the first administration. Medical data was collected by review of medical care records. The researcher checked for absent responses after receiving the questionnaire and asked patients to answer to the missing items.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned: 01/01/2019

Actual: 04/02/2019

Study start date

Planned: 01/10/2019

Actual: 02/12/2019

Data analysis start date

Planned: 01/02/2020

Actual: 25/02/2020

Date of final study report

Planned: 01/05/2020

Actual: 01/06/2020

Sources of funding

Other

More details on funding

Private centre

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable