Sensory Isolation to Reduce Anxiety During Bronchoscopy

Официальное название

The Effect of Sensory Isolation on Physiological Indicators of Anxiety in Patients Undergoing Fiberoptic Bronchoscopy: A Randomized Controlled Trial

Обзор

TThis randomized controlled trial aims to evaluate the effect of sensory isolation on anxiety and physiological parameters in patients undergoing fiberoptic bronchoscopy. The intervention involves the use of an eye mask and earplugs to reduce environmental stimuli. The study will comparatively assess the effects of sensory isolation on anxiety levels and physiological parameters, including blood pressure, heart rate, and oxygen saturation.

Подробное описание

This study is designed as a parallel-group, randomized controlled trial to evaluate the effect of sensory isolation on anxiety and physiological parameters in patients undergoing fiberoptic bronchoscopy. The research will be conducted at the Ege University Faculty of Medicine, Department of Chest Diseases, Bronchoscopy Unit, and the Suat Seren Chest Diseases and Thoracic Surgery Training and Research Hospital.

Participants who meet the inclusion criteria and provide written informed consent will be randomly assigned in a 1:1 ratio to either the intervention group (sensory isolation using an eye mask and earplugs) or the control group (standard care). To ensure balanced distribution between groups and to minimize potential confounding effects on anxiety and physiological responses, stratified block randomization will be applied based on age group (under 65 years and 65 years and older) and gender. Within each stratum, randomization sequences will be generated using Random.org (List Randomizer) with a fixed block size of six (3 intervention, 3 control).

Allocation concealment will be ensured through the use of sequentially numbered, opaque, sealed envelopes prepared separately for each stratum. At the time of enrollment, participants will be assigned to groups according to the next envelope in sequence, thereby preventing foreknowledge of group allocation and minimizing selection bias.

The randomization and reporting processes of the study will be conducted in accordance with the CONSORT (Consolidated Standards of Reporting Trials) 2025 guidelines to ensure methodological rigor, internal validity, and transparency.

Вмешательства

• Поведенческое Sensory Isolation (Eye Mask and Earplugs)
  Participants assigned to the intervention group will receive sensory isolation using an eye mask and earplugs applied approximately 10 minutes before and during the fiberoptic bronchoscopy procedure. This is a non-pharmacological behavioral nursing intervention intended to minimize exposure to visual and auditory stimuli. Anxiety levels and physiological parameters will be assessed at predefined time points before, during, and after the procedure.

Первичные конечные точки

• Anxiety level (State Anxiety Inventory - STAI) [Срок оценки: Baseline (10 minutes before bronchoscopy) and end of procedure (10th minute)]

Вторичные конечные точки (5)

• Heart rate [Срок оценки: 10 minutes before, start of procedure (0 min), 5th minute, end of procedure (10th minute), and 20 minutes after the procedure]
• Systolic blood pressure [Срок оценки: 10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure]
• Diastolic blood pressure [Срок оценки: 10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure]
• Respiratory rate [Срок оценки: 10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure]
• Oxygen saturation (SpO₂) [Срок оценки: 10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure]

Критерии участия

Критерии включения

• Patients undergoing fiberoptic bronchoscopy (FOB) for the first time.
• Aged 18 years or older.
• Able to read and understand written study materials.
• Willing to participate and able to provide written informed consent.
• Able to communicate effectively and cooperate during data collection.
• Undergoing fiberoptic bronchoscopy under local anesthesia only, without general anesthesia or procedural sedation.

Критерии исключения

• Patients requiring emergency bronchoscopy.
• Patients requiring endotracheal intubation or invasive mechanical ventilation during the procedure.
• Patients who withdraw consent or are unable to comply with the study protocol.
• Patients with a diagnosed psychiatric disorder that may affect anxiety assessment.
• Patients with dementia or other cognitive impairments affecting comprehension or cooperation.
• Patients with severe cardiovascular disease, including advanced heart failure.
• Individuals with hearing or visual impairments that interfere with the application of sensory isolation procedures.
• Patients whose fiberoptic bronchoscopy procedure exceeds 10 minutes in duration.fiberoptic bronchoscopy lasts longer than 10 minutes.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 2 центра

• Ege University Faculty of Medicine, Department of Chest Diseases, Bronchoscopy Unit — Izmir
• Suat Seren Chest Diseases and Thoracic Surgery Training and Research Hospital — Izmir

Идентификаторы

NCT: NCT07374783 · EGE-BRONCH-2025-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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