Sensory Isolation to Reduce Anxiety During Bronchoscopy (Bronchoscopy)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety Physiological Stress Responses ,Fiberoptic Bronchoscopy, Sensory Isolation
• Intervention / Treatment: Behavioral: Sensory Isolation (Eye Mask and Earplugs)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melek YÜKSEL, MSc, PhD Candidate; Phone Number: +902323902973 +905078667595; Email: melek.yuksel@ege.edu.tr
• Study Contact Backup: Name: Leyla KHORSHİD, PhD; Phone Number: +902323115557 +905056703378; Email: khorshidleyla@gmail.com

Study Locations

• Turkey (Türkiye)
  • Izmir, Turkey (Türkiye)
    • Ege University Faculty of Medicine, Department of Chest Diseases, Bronchoscopy Unit
    • Contact: Melek YUKSEL, MSc, PhD Candidate; Phone Number: +90 507 866 7595; Email: melek.yuksel@ege.edu.tr
    • Contact: Leyla KHORSHİD, PhD; Phone Number: +90 505 670 3378; Email: khorshidleyla@gmail.com
  • Izmir, Turkey (Türkiye)
    • Suat Seren Chest Diseases and Thoracic Surgery Training and Research Hospital
    • Contact: Melek YUKSEL, MSc, PhD Candidate; Phone Number: +90 507 866 7595; Email: melek.yuksel@ege.edu.tr
    • Contact: Leyla KHORSHİD, PhD; Phone Number: +90 505 670 3378; Email: khorshidleyla@gmail.com
    • Principal Investigator: Leyla KHORSHİD, PhD
    • Sub-Investigator: Melek YUKSEL, MSc, PhD Candidate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group - Sensory Isolation; 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.	Behavioral: 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.; Other Names: Eye mask and earplug intervention; Sensory isolation
No Intervention: Control Group - Standard Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (10 minutes before bronchoscopy) and end of procedure (10th minute)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate will be measured using standard clinical monitoring to assess physiological stress responses during fiberoptic bronchoscopy.	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.	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.	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.	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.	10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure

Collaborators and Investigators

• Sponsor: Melek YÜKSEL
• Collaborators: Ege University
• Investigators: Study Director: Leyla KHORSHİD, PhD, Ege University, Faculty of Nursing

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2026
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Sensory isolation Anxiety Physiological responses Nursing intervention Randomized controlled trial, Pre-procedural anxiety, Nonpharmacological intervention
• Additional Relevant MeSH Terms: Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture; Protective Devices; Personal Protective Equipment; Protective Clothing; Clothing; Ear Protective Devices
• Other Study ID Numbers: EGE-BRONCH-2025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because the study involves patient-specific clinical and psychological data collected under institutional ethics approval. Data sharing is restricted to protect participant confidentiality in accordance with national and international data protection regulations (KVKK/GDPR). Only aggregated and fully anonymized results will be disseminated through scientific publications and academic presentations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No