Sensory Isolation to Reduce Anxiety During Bronchoscopy

Melek YÜKSEL

Status: Begins enrollment this month

Conditions: Anxiety Physiological Stress Responses ,Fiberoptic Bronchoscopy, Sensory Isolation

Treatments: Behavioral: Sensory Isolation (Eye Mask and Earplugs)

Study type: Interventional

Funder types: Other

Identifiers

NCT07374783

EGE-BRONCH-2025-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Intervention Group - Sensory Isolation

Experimental group

Description:

Participants in this group will receive sensory isolation using an eye mask and earplugs applied approximately 10 minutes before and during the fiberoptic bronchoscopy procedure. Physiological parameters (blood pressure, heart rate, respiratory rate, and oxygen saturation) and anxiety levels will be assessed at predefined time points before, during, and after the procedure.

Treatment:

Behavioral: Sensory Isolation (Eye Mask and Earplugs)

Control Group - Standard Care

No Intervention group

Description:

Participants in this group will receive routine standard care during fiberoptic bronchoscopy without the use of sensory isolation tools. Anxiety levels and physiological parameters will be assessed at the same predefined time points as in the intervention group.