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临床试验/NCT07404956
NCT07404956招募中不适用

COMPARISON OF THE EFFECTS OF SURGICAL MASK AND N95 MASK USE ON PHYSICAL SYMPTOMS OF SURGICAL SMOKE IN OPERATING ROOM

Bartın Unıversity1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年9月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
38
试验地点
1
主要终点
Surgical Smoke-Related Physical Symptom Severity (Total NRS Score)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

盲法说明

Outcome assessment and data analysis were conducted by an independent assessor blinded to the type of mask used.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Surgical Mask

Experimental

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

干预措施: Surgical Mask (Device)

N95 Mask

Experimental

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

干预措施: N95 Mask (Device)

结局指标

主要结局

Surgical Smoke-Related Physical Symptom Severity (Total NRS Score)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Bartın Unıversity
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hilal Çetin Baltutar

Nurse

Bartın Unıversity

研究点 (1)

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