Evaluation of Efficacy of Coconut Oil Mouth Care for Non-autonomous Hospitalised Elderly People: a Multicentric Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Revised Oral Assement Guide (ROAG) between Day 1 and Day 8
研究概览
简要总结
This is a prospective, longitudinal, randomised, open-label, multicentric, interventional, comparative superiority study.
The main objective is to demonstrate the superiority of oral care with coconut oil on the oral status of elderly people hospitalised in geriatrics, versus oral care with glycerol sticks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 75 and over
- •Patients hospitalised in geriatric medicine and geriatric SMR departments
- •Patients able to open their mouths for treatment
- •Patients not able to carry out their oral hygiene on their own
- •Patients who have given their written consent (consent of the patient or patient consent accompanied by the designated representative if the patient is unable to give written consent)
排除标准
- •Patients with a known allergy to coconut
- •Patients requiring medicated mouth care as prescribed by a doctor
- •Patients under guardianship, tutorship or curatorship
- •Confused patients who have had medically diagnosed dehydration for less than 48 hours
- •Patients with swallowing difficulties
- •Patients in the terminal phase of end of life
- •Secondary exclusion criteria:
- •Patients leaving the department between D1 and D8 (whatever the reason for discharge, and including in the event of death)
- •Patients whose condition progresses towards a terminal phase of the end of life between D1 and D8
- •Patients experiencing an allergic reaction to Coconut Oil during the study
- •Patients who may present with dehydration during the study
研究组 & 干预措施
Coconut oil mouth care
Daily oral care is done with coconut oil throughout the patient's hospitalization
干预措施: Coconut oil mouth care (Procedure)
Glycerin mouthwashes
Daily oral care is performed with glycerin sticks as in current practice.
干预措施: Glycerin mouthwashes (Procedure)
结局指标
主要结局
Revised Oral Assement Guide (ROAG) between Day 1 and Day 8
时间窗: From Day 1 to Day 8
Change in total score between Day 1 (D1) and Day 8 (D8) on the Revised Oral Assessment Guide (ROAG), translated and validated in French. The scale assesses 8 indicators (voice, swallowing, lips, tongue,saliva, mucous membranes, gums and teeth) according to 3 levels. The result gives a total score out of 24 points
次要结局
- Weekly ROAG scores (Revised Oral Assment Guide)(Every week from the date of inclusion until the date of discharge, on average over 37 days.)
- ROAG betwen Day 1 (D1) and Day 8 (D8) for patients with "palliative care" status(from Day 1 to Day 8)
- Number of oral care stopped(At the end of the study, on average of 37 days.)