Anxiety Physiological Stress Responses ,Fiberoptic Bronchoscopy, Sensory IsolationBronchoscopyNCT07374783
Sensory Isolation to Reduce Anxiety During Bronchoscopy
A study testing Sensory Isolation (Eye Mask and Earplugs) in people with Anxiety Physiological Stress Responses ,Fiberoptic Bronchoscopy, Sensory Isolation, run by Melek YÜKSEL at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Physiological Stress Responses ,Fiberoptic Bronchoscopy, Sensory Isolation
- What is being tested?
- Sensory Isolation (Eye Mask and Earplugs)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Feb 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Ege University Faculty of Medicine, Department of Chest Diseases, Bronchoscopy Unit
Izmir
Melek YUKSEL, MSc, PhD Candidate, +90 507 866 7595, melek.yuksel@ege.edu.tr
Leyla KHORSHİD, PhD, +90 505 670 3378, khorshidleyla@gmail.com
Suat Seren Chest Diseases and Thoracic Surgery Training and Research Hospital
Izmir
Melek YUKSEL, MSc, PhD Candidate, +90 507 866 7595, melek.yuksel@ege.edu.tr
Leyla KHORSHİD, PhD, +90 505 670 3378, khorshidleyla@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Sensory Isolation (Eye Mask and Earplugs)
- Keywords
- Sensory isolation Anxiety Physiological responses Nursing intervention Randomized controlled trial, Pre-procedural anxiety, Nonpharmacological intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Isolation (Eye Mask and Earplugs)Behavioural
Also called Eye mask and earplug intervention; Sensory isolation
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - Sensory Isolation | Experimental | 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. Receives: Behavioral: Sensory Isolation (Eye Mask and Earplugs) |
| Control Group - Standard Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (10 minutes before bronchoscopy) and end of procedure (10th minute)
Secondary outcomes (5)
Heart rate
Heart rate will be measured using standard clinical monitoring to assess physiological stress responses during fiberoptic bronchoscopy.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start20 Feb 2026 (estimated)
- Primary completion20 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Physiological Stress Responses ,Fiberoptic Bronchoscopy, Sensory IsolationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melek YÜKSEL
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Sponsor-investigator, Melek YÜKSEL, Ege University
- Investigators
- Leyla KHORSHİD, PhD, Study director, Ege University, Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374783
- Sponsor's protocol ID
- EGE-BRONCH-2025-01
- Acronym
- Bronchoscopy
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sensory Isolation on Physiological Indicators of Anxiety in Patients Undergoing Fiberoptic Bronchoscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07374783
- Acronym / sponsor ID
- Bronchoscopy / EGE-BRONCH-2025-01
- Keywords
- Sensory isolation Anxiety Physiological responses Nursing intervention Randomized controlled trial, Pre-procedural anxiety, Nonpharmacological intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Melek YÜKSELUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Sensory Isolation | Experimental | Behavioral: Sensory Isolation (Eye Mask and Earplugs)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. |
| Control Group - Standard Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory Isolation (Eye Mask and Earplugs)Also: Eye mask and earplug intervention; Sensory isolationParticipants 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. | Behavioural | Intervention Group - Sensory Isolation |
Primary outcome
Anxiety level (State Anxiety Inventory - STAI)
Time frame: 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.
5 secondary outcomes
Heart rate
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
Time frame: 10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure
Diastolic blood pressure
Time frame: 10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure
Respiratory rate
Time frame: 10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure
Oxygen saturation (SpO₂)
Time frame: 10 minutes before, 0 min, 5 min, 10 min, and 20 min post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leyla KHORSHİD, PhD study director
Ege University, Faculty of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Isolation (Eye Mask and Earplugs) in people with Anxiety Physiological Stress Responses ,Fiberoptic Bronchoscopy, Sensory Isolation, run by Melek YÜKSEL at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melek YÜKSEL, MSc, PhD Candidate (+905078667595 ext. +902323902973, melek.yuksel@ege.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety level (State Anxiety Inventory - STAI) (time frame: Baseline (10 minutes before bronchoscopy) and end of procedure (10th minute)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026; AzTrials last refreshed its copy on 27 Oct 2026.