Validation and Cross-cultural Adaptation of Croatian SECEL Questionnaire

April 28, 2025 updated by: Osijek University Hospital

Validation and Cross-cultural Adaptation of Croatian Self-Evaluation of Communication Experiences After Laryngectomy Questionnaire

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At the first visit all patients included in the study were asked to complete the Croatian version of the Voice Handicap Index (VHI), Short Form Health Survey (SF-36) and Self-Evaluation of Communication Experiences after Laryngectomy (SECEL:HR) questionnaire.

SECEL 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 the Likert scale (0-never, 1-sometimes, 2-often, 3-always). 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), and item number 35 is a separate question: "Do you talk the same amount now as before your laryngectomy?" and is rated with a "yes," "more," and "less" rating category. The overall numerical score varies from 0 to 102, and the higher score indicates greater difficulties and worse postoperative speech-communication adjustment.

The Voice Handicap Index (VHI) questionnaire consist of 30 items organized in three subscales functional, physical and emotional and also scored with Likert scale with overall score from 0 to 120. Higher scores indicate a greater handicap.

The Short Form Health Survey (SF-36) is a multi-purpose short-form health survey that consist of 36 questions divided in eight dimension and clustered into two groups: physical and mental health. Each item was standardized (range 0-100), with a higher score representing better QoL.

The objective assessment includes the maximum phonation time measured in seconds as common clinical measure of glottal efficiency, diadochokinesis of the 3-syllable "pa-ta-ka" in 5 seconds (rated in syll/s) or how quickly subjects can produce a series of rapid sounds which is a measure of speech efficiency.

All patients will fulfil the SECEL:HR questionnaire twice, two weeks after the initial test and that will be considered as a re-test of the SECEL reliability analysis.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Osijek, Croatia, 31000
        • University Hospital Osijek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

All patients who have undergone total laryngectomy were included in this study

Description

Inclusion Criteria:

  1. Patients who completed minimal their 12-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy
  2. Patients with preserved reading skills
  3. Regular presence at follow-up visits

Exclusion Criteria:

  1. Acute respiratory infection of the upper or lower respiratory tract
  2. Presence of neurologic or pulmonary diseases
  3. Recurrence of cancer
  4. Deviation from the research protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult laryngectomised patients
Patients who have undergone total laryngectomy and completed minimal their 12-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy
Behavioral: Quality of life questionnaire
Filling out questionnaires, measuring maximum phonation and diadochokinesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Means, Standard Deviations of SF-36
Time Frame: 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 a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
15 minutes- required to complete the questionnaire
Means, Standard Deviation of VHI Questionnaire
Time Frame: 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.
15 minutes-required to complete the questionnaire
Means, Standard Deviations (Ranges), Test-retest Reliability of the Self- Evaluation of Communication Experiences After Laryngectomy (SECEL:HR) Questionnaire
Time Frame: 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 is a separate question: "Do you talk the same amount now as before your laryngectomy?" and is rated with a "yes," "more," and "less" rating category. The overall numerical score varies from 0 to 102, where the higher score indicates greater difficulties and worse postoperative speech-communication adjustment.
15 minutes- required to complete the questionnaire

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean, Standard Deviation of Maximum Phonation Time (MPT) and Diadochokinesis (DDK)
Time Frame: 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.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osijek University Hospital

Investigators

  • Principal Investigator: Željka Laksar Klarić, M.D., Clinical Department of ENT and Head and Neck Surgery, Clinical Hospital Centre Osijek

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2021

Primary Completion (Actual)

January 9, 2023

Study Completion (Actual)

February 8, 2023

Study Registration Dates

First Submitted

April 13, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OsijekUH-SECEL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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