Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:31 AM
Study NCT ID:
NCT07404956
Status:
RECRUITING
Last Update Posted:
2026-02-12
First Post:
2025-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
THE EFFECT OF SURGICAL MASK AND N95 MASK USE ON SURGICAL SMOKE IN OPERATING ROOM NURSES
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}, {'id': 'D004244', 'term': 'Dizziness'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D063806', 'term': 'Myalgia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000087162', 'term': 'N95 Respirators'}], 'ancestors': [{'id': 'D058257', 'term': 'Surgical Attire'}, {'id': 'D004865', 'term': 'Equipment and Supplies, Hospital'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D012134', 'term': 'Respiratory Protective Devices'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Outcome assessment and data analysis were conducted by an independent assessor blinded to the type of mask used.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2025-12-31', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Smoke-Related Physical Symptom Severity (Total NRS Score)', 'timeFrame': 'Five days per week for a duration of four weeks both preoperatively and postoperatively', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgical Smoke', 'Masks', 'Operating Room Nurses', 'Occupational Exposure'], 'conditions': ['Surgical Smoke Exposure', 'Occupational Exposure to Surgical Smoke', 'Headache', 'Dizziness', 'Nause and Vomiting', 'Fatigue Symptom', 'Eye Allergies', 'Abdominal Pain (AP)', 'Heart Rate Determination', 'SpO2', 'Muscle Weakness | Patient', 'Muscle Aches', 'Dispnea']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willingness to participate in the study\n* Aged 18 years or older\n* Working as a sterile operating room nurse at least 4 hours per day, 5 days per week\n* Compliance with the protocol requiring continuous use of both surgical mask and N95 mask for at least 4 hours per day\n* Ability to communicate verbally and provide informed consent\n\nExclusion Criteria:\n\n* Diagnosed psychiatric disorders\n* Presence of chronic respiratory, musculoskeletal, or neurological diseases\n* Presence of chronic dermatological conditions or allergies affecting the facial or respiratory area\n* Speech or communication impairments\n* Pregnancy\n* Holding a supervisory role (e.g., charge nurse) or non-sterile nursing role\n* Planned unit change or rotation during the study period'}, 'identificationModule': {'nctId': 'NCT07404956', 'briefTitle': 'THE EFFECT OF SURGICAL MASK AND N95 MASK USE ON SURGICAL SMOKE IN OPERATING ROOM NURSES', 'organization': {'class': 'OTHER', 'fullName': 'Bartın Unıversity'}, 'officialTitle': 'COMPARISON OF THE EFFECTS OF SURGICAL MASK AND N95 MASK USE ON PHYSICAL SYMPTOMS OF SURGICAL SMOKE IN OPERATING ROOM', 'orgStudyIdInfo': {'id': 'BARU-SBF-2025-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgical Mask', 'description': 'Operating room nurses used a standard surgical mask during surgical procedures with exposure to surgical smoke.', 'interventionNames': ['Device: Surgical Mask']}, {'type': 'EXPERIMENTAL', 'label': 'N95 Mask', 'description': 'Operating room nurses used an N95 respirator during surgical procedures with exposure to surgical smoke.', 'interventionNames': ['Device: N95 Mask']}], 'interventions': [{'name': 'Surgical Mask', 'type': 'DEVICE', 'otherNames': ['Medical Surgical Mask'], 'description': 'Standard surgical masks were used by operating room nurses during surgical procedures with exposure to surgical smoke.', 'armGroupLabels': ['Surgical Mask']}, {'name': 'N95 Mask', 'type': 'DEVICE', 'otherNames': ['N95 Respirator'], 'description': 'N95 respirators were used by operating room nurses during surgical procedures with exposure to surgical smoke.', 'armGroupLabels': ['N95 Mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74100', 'city': 'Bartın', 'state': 'Bartın', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Aynur Parlatır, Supervizor', 'role': 'CONTACT', 'email': 'aynurparlatir@gmail.com', 'phone': '+905054416782'}], 'facility': 'Bartın State Hospital', 'geoPoint': {'lat': 41.63583, 'lon': 32.3375}}], 'centralContacts': [{'name': 'Hilal Çetin Baltutar, Nurse', 'role': 'CONTACT', 'email': 'hilalcetinbaltutar@gmail.com', 'phone': '+905336087874'}, {'name': 'Sevim Çelik, Proffessor', 'role': 'CONTACT', 'email': 'scelik@bartin.edu.tr', 'phone': '+905327832989'}], 'overallOfficials': [{'name': 'sevim çelik, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bartin University Health Science Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bartın Unıversity', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bartin State Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nurse', 'investigatorFullName': 'Hilal Çetin Baltutar', 'investigatorAffiliation': 'Bartın Unıversity'}}}}