NCT07404956

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

February 12, 2026

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 31, 2025

Last Update Submit

February 9, 2026

Conditions

Keywords

Surgical SmokeMasksOperating Room NursesOccupational Exposure

Outcome Measures

Primary Outcomes (1)

  • 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.

    Five days per week for a duration of four weeks both preoperatively and postoperatively

Study Arms (2)

Surgical Mask

EXPERIMENTAL

Operating room nurses used a standard surgical mask during surgical procedures with exposure to surgical smoke.

Device: Surgical Mask

N95 Mask

EXPERIMENTAL

Operating room nurses used an N95 respirator during surgical procedures with exposure to surgical smoke.

Device: N95 Mask

Interventions

Standard surgical masks were used by operating room nurses during surgical procedures with exposure to surgical smoke.

Also known as: Medical Surgical Mask
Surgical Mask
N95 MaskDEVICE

N95 respirators were used by operating room nurses during surgical procedures with exposure to surgical smoke.

Also known as: N95 Respirator
N95 Mask

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartın State Hospital

Bartın, Bartın, 74100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

HeadacheDizzinessVomitingFatigueAbdominal PainMyalgia

Interventions

N95 Respirators

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSensation DisordersSigns and Symptoms, DigestiveMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal Pain

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesRespiratory Protective DevicesPersonal Protective EquipmentProtective DevicesSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • sevim çelik, Professor

    Bartin University Health Science Faculty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilal Çetin Baltutar, Nurse

CONTACT

Sevim Çelik, Proffessor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Outcome assessment and data analysis were conducted by an independent assessor blinded to the type of mask used.
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

December 31, 2025

First Posted

February 12, 2026

Study Start

September 15, 2024

Primary Completion

September 15, 2025

Study Completion

February 28, 2026

Last Updated

February 12, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations