Surgical Smoke ExposureNCT07404956
THE EFFECT OF SURGICAL MASK AND N95 MASK USE ON SURGICAL SMOKE IN OPERATING ROOM NURSES
A study testing Surgical Mask and N95 Mask in people with Surgical Smoke Exposure and Occupational Exposure to Surgical Smoke, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to compare the effect of surgical mask and N95 mask use on physical symptoms due to surgical smoke in operating theatre nurses. The study, which was conducted in a single-group prospective quasi-experimental design, was completed with 38 nurses in the operating theatre unit of a state hospital… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Smoke Exposure, Occupational Exposure to Surgical Smoke, Headache
- What is being tested?
- Surgical Mask and N95 Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2024to 28 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willingness to participate in the study
- Aged 18 years or older
- Working as a sterile operating room nurse at least 4 hours per day, 5 days per week
- Compliance with the protocol requiring continuous use of both surgical mask and N95 mask for at least 4 hours per day
- Ability to communicate verbally and provide informed consent
Who cannot join
- Diagnosed psychiatric disorders
- Presence of chronic respiratory, musculoskeletal, or neurological diseases
- Presence of chronic dermatological conditions or allergies affecting the facial or respiratory area
- Speech or communication impairments
- Pregnancy
- Holding a supervisory role (e.g., charge nurse) or non-sterile nursing role
- Planned unit change or rotation during the study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bartın State Hospital
Bartın, Bartın, 74100
Aynur Parlatır, Supervizor, +905054416782, aynurparlatir@gmail.com
About this study
Official title: COMPARISON OF THE EFFECTS OF SURGICAL MASK AND N95 MASK USE ON PHYSICAL SYMPTOMS OF SURGICAL SMOKE IN OPERATING ROOM
This study was conducted to compare the effect of surgical mask and N95 mask use on physical symptoms due to surgical smoke in operating theatre nurses. The study, which was conducted in a single-group prospective quasi-experimental design, was completed with 38 nurses in the operating theatre unit of a state hospital in the Western Black Sea Region. Data were collected for four weeks using the Descriptive Information Form, Numerical Rating Scale and Symptom Follow-up Form. According to the findings, muscle weakness, myalgia in the upper extremities and muscle cramps were statistically significantly less in nurses using N95 masks. Respiratory parameters, watery eyes and redness were significantly lower in nurses using surgical masks. As a result, it was determined that the type of mask was effective on the incidence of physical symptoms related to surgical smoke.
- Conditions
- Surgical Smoke Exposure, Occupational Exposure to Surgical Smoke, Headache, Dizziness, Nause and Vomiting, Fatigue Symptom
- Being tested
- Surgical Mask, N95 Mask
- Keywords
- Surgical Smoke, Masks, Operating Room Nurses, Occupational Exposure
- Medical subject headings
- Headache, Dizziness, Vomiting, Fatigue, Abdominal Pain, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical MaskDevice
Also called Medical Surgical Mask
Standard surgical masks were used by operating room nurses during surgical procedures with exposure to surgical smoke.
N95 MaskDevice
Also called N95 Respirator
N95 respirators were used by operating room nurses during surgical procedures with exposure to surgical smoke.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Mask | Experimental | Operating room nurses used a standard surgical mask during surgical procedures with exposure to surgical smoke. Receives: Device: Surgical Mask |
| N95 Mask | Experimental | Operating room nurses used an N95 respirator during surgical procedures with exposure to surgical smoke. Receives: Device: N95 Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Smoke-Related Physical Symptom Severity (Total NRS Score)
The severity of physical symptoms related to surgical smoke exposure in operating room nurses, including headache, abdominal pain, nausea and vomiting, fatigue/weakness, loss of appetite, and dyspnea, was assessed using the Numeric Rating Scale (NRS). Each symptom was rated on a standardized numeric scale, and a total symptom severity score was calculated by summing the individual symptom scores. Higher scores indicate greater symptom severity.
Measured: Five days per week for a duration of four weeks both preoperatively and postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start15 Sep 2024
- Primary completion15 Sep 2025
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Smoke ExposureStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Collaborators
- Bartin State Hospital
- Responsible party
- Principal investigator, Hilal Çetin Baltutar, Bartın Unıversity
- Investigators
- sevim çelik, Professor, Principal investigator, Bartin University Health Science Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404956
- Sponsor's protocol ID
- BARU-SBF-2025-01
- Status last verified
- Dec 2025
- First submitted
- 31 Dec 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF THE EFFECTS OF SURGICAL MASK AND N95 MASK USE ON PHYSICAL SYMPTOMS OF SURGICAL SMOKE IN OPERATING ROOM
- ClinicalTrials.gov ID
- NCT07404956
- Acronym / sponsor ID
- BARU-SBF-2025-01
- Conditions
- Surgical Smoke Exposure, Occupational Exposure to Surgical Smoke, Headache, Dizziness, Nause and Vomiting, Fatigue Symptom
- Keywords
- Surgical Smoke, Masks, Operating Room Nurses, Occupational Exposure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Collaborators
- Bartin State Hospital
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 12 Feb 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.
This study was conducted to compare the effect of surgical mask and N95 mask use on physical symptoms due to surgical smoke in operating theatre nurses. The study, which was conducted in a single-group prospective quasi-experimental design, was completed with 38 nurses in the operating theatre unit of a state hospital in the Western Black Sea Region. Data were collected for four weeks using the Descriptive Information Form, Numerical Rating Scale and Symptom Follow-up Form. According to the findings, muscle weakness, myalgia in the upper extremities and muscle cramps were statistically significantly less in nurses using N95 masks. Respiratory parameters, watery eyes and redness were significantly lower in nurses using surgical masks. As a result, it was determined that the type of mask was effective on the incidence of physical symptoms related to surgical smoke.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Mask | Experimental | Device: Surgical MaskOperating room nurses used a standard surgical mask during surgical procedures with exposure to surgical smoke. |
| N95 Mask | Experimental | Device: N95 MaskOperating room nurses used an N95 respirator during surgical procedures with exposure to surgical smoke. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willingness to participate in the study
- Aged 18 years or older
- Working as a sterile operating room nurse at least 4 hours per day, 5 days per week
- Compliance with the protocol requiring continuous use of both surgical mask and N95 mask for at least 4 hours per day
- Ability to communicate verbally and provide informed consent
Key exclusion criteria (7 listed)
- Diagnosed psychiatric disorders
- Presence of chronic respiratory, musculoskeletal, or neurological diseases
- Presence of chronic dermatological conditions or allergies affecting the facial or respiratory area
- Speech or communication impairments
- Pregnancy
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 |
|---|---|---|
| Surgical MaskAlso: Medical Surgical MaskStandard surgical masks were used by operating room nurses during surgical procedures with exposure to surgical smoke. | Device | Surgical Mask |
| N95 MaskAlso: N95 RespiratorN95 respirators were used by operating room nurses during surgical procedures with exposure to surgical smoke. | Device | N95 Mask |
Primary outcome
Surgical Smoke-Related Physical Symptom Severity (Total NRS Score)
Time frame: Five days per week for a duration of four weeks both preoperatively and postoperatively
The severity of physical symptoms related to surgical smoke exposure in operating room nurses, including headache, abdominal pain, nausea and vomiting, fatigue/weakness, loss of appetite, and dyspnea, was assessed using the Numeric Rating Scale (NRS). Each symptom was rated on a standardized numeric scale, and a total symptom severity score was calculated by summing the individual symptom scores. Higher scores indicate greater symptom severity.
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 12 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Surgical Smoke Exposure
Not yet recruitingObservational study
Preoperative Smoke Check and Surgical Smoke Evacuation Compliance
Surgical Smoke Exposure
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Effectiveness of Brief Smoking Cessation Counselling in Pre-Anaesthesia Assessment Clinic
Smoking ( Cigarette)
RecruitingObservational study
AI-Based Real-Time Detection of Surgical Smoke Using Endoscopic Data
Detection of Surgical Smoke Gas Using AI
Not yet recruiting
The Effect of Masks on Surgical Smoke Exposure
Surgical Smoke
Recruiting
Effects of Multi-strategy Evidence-based Education Training Programs on Knowledge, Attitude, and Preventive Behavior Towards Surgical Smoke Hazards Among Operating Room Nurses
Electrocautery Smoke
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.
sevim çelik, Professor principal investigator
Bartin University Health Science Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Mask and N95 Mask in people with Surgical Smoke Exposure and Occupational Exposure to Surgical Smoke, run by Bartın Unıversity at 1 site 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Hilal Çetin Baltutar, Nurse (+905336087874, hilalcetinbaltutar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Smoke-Related Physical Symptom Severity (Total NRS Score) (time frame: Five days per week for a duration of four weeks both preoperatively and postoperatively). 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 12 Feb 2026.