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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
120
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.
Ege University Faculty of Medicine, Department of Chest Diseases, Bronchoscopy Unit
Izmir, Turkey (Türkiye)
Suat Seren Chest Diseases and Thoracic Surgery Training and Research Hospital
Izmir, Turkey (Türkiye)
Anxiety level (State Anxiety Inventory - STAI)
Anxiety will be assessed using the State Anxiety Inventory (STAI; score range 20-80, with higher scores indicating greater anxiety). Anxiety levels will be compared between the intervention and control groups to evaluate the effect of sensory isolation during fiberoptic bronchoscopy.
Time frame: Baseline (10 minutes before bronchoscopy) and end of procedure (10th minute)
Heart rate
Heart rate will be measured using standard clinical monitoring to assess physiological stress responses during fiberoptic bronchoscopy.
Time frame: 10 minutes before, start of procedure (0 min), 5th minute, end of procedure (10th minute), and 20 minutes after the procedure
Systolic blood pressure
Systolic blood pressure will be measured using automated monitors to evaluate hemodynamic responses during the procedure.
Time frame: 10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure
Diastolic blood pressure
Diastolic blood pressure will be measured using automated monitors to evaluate hemodynamic responses during the procedure.
Time frame: 10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure
Respiratory rate
Respiratory rate will be measured to evaluate respiratory stress responses during fiberoptic bronchoscopy.
Time frame: 10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure
Oxygen saturation (SpO₂)
Peripheral oxygen saturation will be measured using standard pulse oximetry to detect changes during fiberoptic bronchoscopy.
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Time frame: 10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure