The Effect of Sensory Isolation on Physiological Indicators of Anxiety in Patients Undergoing Fiberoptic Bronchoscopy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Anxiety level (State Anxiety Inventory - STAI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Sensory Isolation (Eye Mask and Earplugs) (Behavioral)
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.
结局指标
主要结局
Anxiety level (State Anxiety Inventory - STAI)
时间窗: 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.
次要结局
- Heart rate(10 minutes before, start of procedure (0 min), 5th minute, end of procedure (10th minute), and 20 minutes after the procedure)
- Systolic blood pressure(10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure)
- Diastolic blood pressure(10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure)
- Respiratory rate(10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure)
- Oxygen saturation (SpO₂)(10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure)
研究者
Melek YÜKSEL
Ege University Faculty of Nursing
Ege University