Development and Validation of Voice questionnaire for assessing the Voice problems among Fishermen in South Canara region of Karnataka

Title of the project

Development and Validation of Voice Questionnaire for Assessing the Voice Disorders among Fishermen in South Canara Region of Karnataka

Type of Study

Prospective study cross-sectional study

Aims and Objectives

1. Development and validation of voice questionnaire for assessing the voice disorder in fishermen in the South Canara region of Karnataka

2. To conduct a pilot study to assess the voice disorders among fishermen in the South Canara region of Karnataka

Justification for Study

The possible occupational hazards associated with coastal fishing might contribute to the voice problems among fishermen. Those include exposure to harsh environmental conditions such as cold air, sea breezes, and saltwater, as well as loud noises from motor engines and emissions from trawler fuel exhaust. These can negatively impact the respiratory system and lead to vocal health issues which can affect voice quality. Additionally, the physical demands of fishing, combined with long work hours without breaks, can result in overall fatigue that compromises vocal health. Fishermen may also have limited access to vocal health education or training, making them more susceptible to voice problems. Furthermore, there is a significant lack of targeted research on this demographic, emphasizing the need to evaluate their vocal health risks.

Department Involved

Department of Speech and Hearing, Manipal College of Health Professions, Manipal

Study Period

April 2025 to May 2026

Sample Size

30

Materials and Methods

Inclusion and Exclusion Criteria

The criteria for including individuals are fishermen of age 18 to 59 years from coastal regions of Udupi and Dakshina Kannada

The criteria for excluding individuals are individuals with history of major laryngeal surgery or chronic malignant conditions

Detailed description of procedure and processes: Approval from the Institutional Research Committee (IRC), Institutional Ethics Committee (IEC), and Clinical Trials Registry of India (CTRI) registration will be completed and then the study will be conducted. Informed consent will be obtained from participants or their caregivers. Only individuals meeting the selection criteria will be included in the study. The study involves two phases. Phase one involves development and validation of a voice questionnaire with three steps such as conceptualization and construction of a questionnaire, content validation, and cognitive debriefing. Phase two involves a pilot study.

Phase 1 Development and validation of voice questionnaire

Conceptualization and construction of a questionnaire

The development of a self-reported questionnaire in Kannada will include collecting the information available in the review of literature using the deductive method. This method will include reviewing articles from various databases for relevant studies and voice assessment tools such as Cochrane Central Register of Control Trials, Cumulative Index to Nursing and Allied Health Literature, Embase, Ovid Medline, ProQuest Medical Library, PubMed Medline, Scopus, and Web of Science. A structured Delphi method will be employed to achieve consensus on the most relevant items in the questionnaire. This will include ten experts comprising five experienced Speech Language Pathologists and five fishermen. The five Speech Language Pathologists will be proficient in Kannada with a minimum of five years of experience in the assessment and management of voice disorders. Similarly, five fishermen proficient in Kannada with a minimum of five years of experience will be involved to obtain their opinions. Written consent will be obtained from all experts after informing them of the purpose of the study, the estimated time required, the participation criteria, their need to engage in the research process, and the voluntary nature of the Delphi study. The first Delphi round will involve open ended questions to gather a broad set of possible items and suggestions. In the subsequent rounds, the proposed items will be presented for evaluation using a three point rating scale with one for not relevant, two for somewhat relevant, and three for highly relevant. Items rated as two or three will be considered for inclusion, following further discussion and refinement. The process will continue until consensus is achieved on the most appropriate and relevant items to be included in the questionnaire. The possible subsections of this questionnaire might consist of demographic details, voice related symptoms, phonotraumatic behaviors, lifestyle or substance use, medical conditions

Content Validation: Following the Delphi process, the refined questionnaire will be distributed among five experienced Speech Language Pathologists with Kannada as their first language and having a minimum of five years of experience in the assessment and management of voice disorders, who are different from those involved in the development phase. These experts will review each item for clarity and relevance using a three point rating scale with one for non relevant, two for somewhat relevant, and three for highly relevant. Items rated as two and three will be considered for inclusion. The Content Validity Index will be calculated for each item to determine content adequacy. This stage supports face validity by ensuring that the items appear appropriate and understandable to experts

Cognitive Debriefing: Following expert validation, the revised questionnaire will undergo cognitive debriefing to assess its clarity and cultural appropriateness. This process will involve conducting semi structured interviews with ten fishermen with a minimum of five years of experience, who will be asked to complete the questionnaire and provide verbal feedback on the comprehensibility and perceived relevance of each item. Based on their input, necessary modifications will be made to ensure that the instrument is clearly understood and contextually appropriate for the target population

Phase 2 Pilot study

The finalized version of the questionnaire will be administered on 30 fishermen who meet the inclusion criteria to explore the feasibility and practicality of administering the developed questionnaire. Informed consent will be obtained prior to participation. Participants will be asked to complete the questionnaire, after which semi-structured interviews will be conducted. These interviews will explore the participants’ experiences with the tool in terms of comprehension of items, time required to complete the questionnaire, ease or difficulty in answering questions and suggestions if any. The interviews will be conducted in Kannada, audio-recorded with consent, and transcribed for analysis

Outcome measures Demographic details Voice related symptoms Phonotraumatic behaviors Lifestyle or substance use Health issues and medical conditions

Potential risks and benefits There may be minimal risk involved in the study, primarily related to the participant’s time commitment to a one time data collection session, which may cause minor discomfort. However, the study offers potential benefits as it will be the first to report the prevalence of voice disorders among fishermen in India, examining voice related symptoms, phonotraumatic behaviors, lifestyle factors including substance use, and associated health issues through a detailed questionnaire. The study creates awareness among Speech Language Pathologists about the voice problems in fishermen and helps in early identification, thereby facilitating further management. Following data collection, the participants will be counselled about vocal health care to be followed in their daily routine.

Ethical considerations and methods to address issues Information from the study including participants’ name, address, medical records, and study results will be reviewed only by the Institutional Ethics Committee, Kasturba Medical College and Kasturba Hospital, Manipal. Information and results from this study will be presented at meetings or published in journals without including participants’ names and their personal identifications.

Budget and proposed funding source The data collection would be carried out through self funding by researchers for travelling.

Review of literature The cumulative incidence of non vocal non professional voice users has been reported as twenty one point six percent by Sheyona and Devadas in 2022. Similarly, this population has reported hoarseness of voice in fifty two point nine percent of the study population by Batra and colleagues in 2004, eighty five point two six percent by Banjara and colleagues in 2011, seventy three percent by Agarwal and colleagues in 2013, and sixty seven point nine percent by Thapa and colleagues in 2022. Also, fishermen who are exposed to fuel exhaust had chronic phlegm in eight point six one percent, wheezing in four point two nine percent, and a higher chance of respiratory symptoms with reduced lung function compared to fishermen with no exposure to fuel exhaust as reported by Moitra and colleagues in 2015. However, there have been limited studies examining vocal health within the fishermen population in both the western and Indian contexts