THE EFFECT OF ORAL CARE WITH PROPOLIS ON THE DEVELOPMENT OF ORAL MUCOSITIS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE RECEIVING TREATMENT IN THE INTENSIVE CARE: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- World Health Organization Oral Mucositis Scoring Index
研究概览
简要总结
The study was conducted in intensive care units and included patients diagnosed with COPD. The study was conducted with a total of 60 COPD patients, 30 in the intervention group and 30 in the control group. Individuals in the intervention group were given an oral care protocol containing propolis for 15 days, in addition to the clinic's standard oral care protocol. The control group continued to receive standard oral care. Oral mucosa was assessed on days 1, 7 and 15.
详细描述
The study was conducted in intensive care units and included patients diagnosed with COPD. The study was conducted with a total of 60 COPD patients, 30 in the intervention group and 30 in the control group. Individuals in the intervention group were given an oral care protocol containing propolis for 15 days, in addition to the clinic's standard oral care protocol. The control group continued to receive standard oral care. Oral mucosa was assessed on days 1, 7 and 15 using the World Health Organization (WHO) Oral Mucositis Scoring Index and the Oral Assessment Guide (Oral Mucosa Score, OMS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older,
- •diagnosed with COPD,
- •no oral mucositis at the start of the study,
- •no known allergy to bees or bee products,
- •able to speak and understand Turkish and communicate effectively,
- •conscious,
- •without any psychiatric illness,
- •without any mental or physical disability that would prevent them from answering questions,
- •individuals who volunteered to participate in the study were included in the study.
排除标准
- •individuals with a cancer diagnosis,
- •individuals receiving immunosuppressive therapy,
- •individuals receiving mechanical ventilation support,
- •individuals with altered consciousness or acute confusion,
- •individuals who did not volunteer to participate in the study were excluded from the research.
研究组 & 干预措施
Control group
The control group continued to receive standard oral care.
Propolis Oral Care Group
Individuals in the intervention group were given an oral care protocol containing propolis for 15 days, in addition to the clinic's standard oral care protocol.
干预措施: Oral care with propolis (Other)
结局指标
主要结局
World Health Organization Oral Mucositis Scoring Index
时间窗: The 1st, 7th, and 15th days were evaluated.
The WHO Oral Mucositis Scoring Index rates the severity of mucositis on a scale of 0 to 4. Grade 0 indicates no mucositis; grade 1 indicates mild mucositis, grade 2 indicates moderate mucositis, and grades 3 and 4 indicate severe mucositis.
Oral Assessment Guide
时间窗: The 1st, 7th, and 15th days were evaluated.
Each assessment area is scored on a scale of 1, 2, or 3 points based on the severity of changes in the oral mucosa. All points obtained from the eight areas are added together to calculate the Total Oral Mucosa Score (OMP). An increase in the total score indicates worsening of oral mucosal damage and associated clinical symptoms. The lowest possible score from the guide is 8, and the highest is 24.
次要结局
未报告次要终点
研究者
Sevda Korkut
instructor
TC Erciyes University