A Study to Evaluate the Patient Burden of Transnasal Endoscopy for Diagnosis of Non-Tuberculous Mycobacterial Disease

UMIN ID: UMIN000056629

Registered date:06/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-Tuberculous mycobacteriosis
• Date of first enrollment: 2024/10/20
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Questionnaire survey of subjects after nasal bronchoscopy.
Questionnaire survey of subjects after oral bronchoscopy.

Outcome(s)

• Primary Outcome: Distress scores reported by subjects after bronchoscopy. The distress score is based on a questionnaire form proposed by the Japan Society for Respiratory Endoscopy, with a five-point scale for each of the following five items: dyspnoea during the examination, pain during the examination, mood after the examination, whether the examination time felt long, and whether the examination should be repeated.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Patients with psychiatric disorders or dementia who have difficulty completing the questionnaire. Patients with factors that may influence the level of distress, such as those taking analgesics such as NSAIDs or opioids, sleep aids, antipsychotics, allergic to local anaesthetics, chronic respiratory failure, pregnant or lactating women. Patients with a history of at least one previous bronchoscopy or upper gastrointestinal endoscopy or a history of head and neck surgery or surgery for pulmonary disease, as patients with factors influencing the subjective factors in the questionnaire.

Related Information

• Primary Sponsor: Toho University
• Source(s) of Monetary Support: None
• Secondary ID(s): M24101