- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07404956
THE EFFECT OF SURGICAL MASK AND N95 MASK USE ON SURGICAL SMOKE IN OPERATING ROOM NURSES
February 9, 2026 updated by: Hilal Çetin Baltutar, Bartın Unıversity
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hilal Çetin Baltutar, Nurse
- Phone Number: +905336087874
- Email: hilalcetinbaltutar@gmail.com
Study Contact Backup
- Name: Sevim Çelik, Proffessor
- Phone Number: +905327832989
- Email: scelik@bartin.edu.tr
Study Locations
-
-
Bartın
-
Bartın, Bartın, Turkey (Türkiye), 74100
- Recruiting
- Bartın State Hospital
-
Contact:
- Aynur Parlatır, Supervizor
- Phone Number: +905054416782
- Email: aynurparlatir@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Surgical Mask
Operating room nurses used a standard surgical mask during surgical procedures with exposure to surgical smoke.
|
Standard surgical masks were used by operating room nurses during surgical procedures with exposure to surgical smoke.
Other Names:
|
|
Experimental: N95 Mask
Operating room nurses used an N95 respirator during surgical procedures with exposure to surgical smoke.
|
N95 respirators were used by operating room nurses during surgical procedures with exposure to surgical smoke.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Five days per week for a duration of four weeks both preoperatively and postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: sevim çelik, Professor, Bartin University Health Science Faculty
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2024
Primary Completion (Actual)
September 15, 2025
Study Completion (Estimated)
February 28, 2026
Study Registration Dates
First Submitted
December 31, 2025
First Submitted That Met QC Criteria
February 9, 2026
First Posted (Actual)
February 12, 2026
Study Record Updates
Last Update Posted (Actual)
February 12, 2026
Last Update Submitted That Met QC Criteria
February 9, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Signs and Symptoms, Digestive
- Sensation Disorders
- Musculoskeletal Pain
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Abdominal Pain
- Headache
- Fatigue
- Vomiting
- Dizziness
- Myalgia
- Surgical Equipment
- Equipment and Supplies
- Manufactured Materials
- Technology, Industry, and Agriculture
- Protective Devices
- Personal Protective Equipment
- Surgical Attire
- Equipment and Supplies, Hospital
- Respiratory Protective Devices
- N95 Respirators
Other Study ID Numbers
- BARU-SBF-2025-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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