Anxiety Physiological Stress Responses ,Fiberoptic Bronchoscopy, Sensory Isolation
Conditions
Keywords
Sensory isolation Anxiety Physiological responses Nursing intervention Randomized controlled trial, Pre-procedural anxiety, Nonpharmacological intervention
Brief summary
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.
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.
Interventions
BEHAVIORALSensory 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.
Sponsors
Melek YÜKSEL
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This study follows a parallel-group, randomized controlled design. Participants who meet the inclusion criteria will be 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). Randomization will be stratified by age group (under 65 years and 65 years and older) and gender to ensure balanced group distribution.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety level (State Anxiety Inventory - STAI) | Baseline (10 minutes before bronchoscopy) and end of procedure (10th minute) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | 10 minutes before, start of procedure (0 min), 5th minute, end of procedure (10th minute), and 20 minutes after the procedure | Heart rate will be measured using standard clinical monitoring to assess physiological stress responses during fiberoptic bronchoscopy. |
| Systolic blood pressure | 10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure | Systolic blood pressure will be measured using automated monitors to evaluate hemodynamic responses during the procedure. |
| Diastolic blood pressure | 10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure | Diastolic blood pressure will be measured using automated monitors to evaluate hemodynamic responses during the procedure. |
| Respiratory rate | 10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure | Respiratory rate will be measured to evaluate respiratory stress responses during fiberoptic bronchoscopy. |
| Oxygen saturation (SpO₂) | 10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure | Peripheral oxygen saturation will be measured using standard pulse oximetry to detect changes during fiberoptic bronchoscopy. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMelek YÜKSEL, MSc, PhD Candidate
CONTACTLeyla KHORSHİD, PhD
STUDY_DIRECTORLeyla KHORSHİD, PhD
Ege University, Faculty of Nursing
Outcome results
None listed