Adults 18 to 90, any sex, with Larynx Neoplasm or Laryngectomy; Status. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Means, Standard Deviations (Ranges), Test-retest Reliability of the Self- Evaluation of Communication Experiences After Laryngectomy (SECEL:HR) QuestionnairePrimary· 15 minutes- required to complete the questionnaire
Completing the Croatian version of the SECEL questionnaire. Questionnaire consists of two parts. The first part examines the relevant general data on the person filling out the questionnaire, while the second part consists of 35 items questionably or statement-designed to examine communication experiences. Patients estimates the incidence of these communication difficulties on a 4-point scale (0-never, 1-sometimes, 2-often, 3-always) The 35 items are grouped according to 3 subscales named General (0-15 score range), Environment (0-42 score range) and Attitude (0-45 score range). Item number 35
Re- Test (standard deviation)
Group
Value
95% CI
SECEL:HR = General Subscale
4.69
± 2.7
SECEL:HR = Environment Subscale
16.33
± 8.4
SECEL:HR = Attitude Subscale
9.38
± 8.8
SECEL:HR = Total
30.10
± 17.5
Test (standard deviation)
Group
Value
95% CI
SECEL:HR = General Subscale
4.21
± 2.4
SECEL:HR = Environment Subscale
14.85
± 2.4
SECEL:HR = Attitude Subscale
7.49
± 7.0
SECEL:HR = Total
26.51
± 14.1
Means, Standard Deviations of SF-36Primary· 15 minutes- required to complete the questionnaire
Completing the Croatian version of the Short Form Health Survey (SF-36) questionnaire. The SF-36 consist of 36 questions divided in eight dimension and clustered into two groups: physical and mental health. The 8 groups of questions are: physical functioning (SF-PF), role limitations due to physical problems (SF-RP), bodily pain ( SF-BP), general health (SF-GH), vitality (SF-VT), social functioning (SF-SF), emotional role ( SF-RE), mental health (SF-MH), change in health (SF-HC).
To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain
Group
Value
95% CI
SF-PF
75.50
± 16.2
SF-RP
60.00
± 41.3
SF-BP
77.20
± 26.1
SF-GH
62.60
± 15.8
SF-VT
68.20
± 18.2
SF-SF
78.38
± 20.6
SF-RE
78.02
± 37.9
SF-MH
72.88
± 19.6
SF-HC
56.00
± 22.3
Means, Standard Deviation of VHI QuestionnairePrimary· 15 minutes-required to complete the questionnaire
Completing the Croatian version of the Voice Handicap Index (VHI) questionnaire. The Voice Handicap Index (VHI) questionnaire consist of 30 items organized in three subscales: functional, physical and emotional, scored on 5-point scale (0-never, 1-almost never, 2-sometimes, 3-almost always, 4-always) with overall score from 0 to 120. Higher scores indicate a greater handicap.
Group
Value
95% CI
VHI E - Emotional Subscale of VHI
7.50
± 7.6
VHI F- Functional Subscale of VHI
15.84
± 7.6
VHI P - Physical Subscale of VHI
12.70
± 8.7
VHI TOT - VHI Total Score
35.86
± 19.9
Mean, Standard Deviation of Maximum Phonation Time (MPT) and Diadochokinesis (DDK)Secondary· 5 minutes
The maximum phonation time (measured in seconds) for which a person can sustain a vowel sound when produced on 1 deep breath at a comfortable pitch and loudness and is a common clinical measure of glottal efficiency.
Diadochokinesis of the 3-syllable "pa-ta-ka" in 5 seconds (rated in syll/s),and the number of syllables per second of the 5 sentences. Diadochokinesis measures how quickly an individual can accurately produce a series of rapid, alternating sounds and is a simple and common clinical measure of speech efficiency.
Group
Value
95% CI
MPT - The Maximum Phonation Time
8.55
± 4.2
DDK -Diadochokinesis
8.94
± 2.0
Sponsor's own description
Self-Evaluation of Communication Experiences after Laryngectomy (SECEL) questionnaire has been developed, with the aim of evaluating rehabilitation needs and the psychosocial care for patients with laryngeal cancer. This short but comprehensive self-report instrument measures the perceived adjustment to communication experiences and is intended to aid in determining counselling needs in patients with laryngeal cancer who are treated with a laryngectomy. The first aim of this study is to evaluate the translation, psychometric properties and cultural adaptation of a Croatian version of the SECEL questionnaire. Secondary aim is to examine relationship between the Croatian version of the SECEL and the Short Form Health Survey (SF-36) and the Voice Handicap Index (VHI) questionnaires and to examine relationship between objective voice measures and Self-Evaluation of Communication Experiences after Laryngectomy (SECEL:HR).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Osijek University Hospital
Last refreshed: 6 May 2025
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