Effectiveness of a Combined Aloe Vera–Peppermint Gel on Prevention Pressure Injuries among Intensive Care Unit Patients: A Randomized Controlled Trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- Self-funded
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Incidence of pressure injuries
研究概览
简要总结
- To evaluate the effectiveness of an Aloe Vera–Peppermint compound gel in the prevention of pressure injuries among ICU patients.
- To examine the relationship between the use of Aloe Vera–Peppermint gel and the demographic characteristics of ICU patients in relation to pressure injury prevention.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 18 至 100（—）
- 性别
- All
入选标准
- •1.ICU patients aged 18 years or older.
- •2.Admission to the ICU without pressure injury according to the NPUAP scale on the first day of hospitalization.
- •3.Unconsciousness, being under sedation or assisted ventilation.
- •4.Patients that are at risk of moderate to severe PIs according to Braden scoring tool and scored less than 13–
- •5.No Diarrhea, serum Albumin level below 3.5 g/dl, no edema.
- •6.No limit of changes in body position with multiple injuries.
- •7.Family consent to participate in the study.
- •8.The patient has no history of autoimmune diseases, renal failure, or diabetes, does not use immunosuppressive medications, and has no evidence of vascular disease.
- •9.All patients receiving standardized care (repositioning and pressure-relieving mattress).
排除标准
- •1.Family’s unwillingness for the patient to continue participation
- •2.Sensitivity to Aloe Vera-Peppermint Gel after use on a patient's forearm (area of 2 × 2 cm) and this area was evaluated for the presence of redness, swelling and warmth within 45 min.
- •3.Spinal cord injury cases
- •4.Death or patient transmission in less than 48 hrs. after admission to the ICU.
研究组 & 干预措施
Interventional group
In the experimental group, researchers first tested a part of Aloe Vera- Peppermint gel on the inner region of forearm, left for 15–30 minutes initially for immediate reactions. Then observed again at 24 hours for delayed hypersensitivity reactions and if it does not cause an allergic reaction, it was rubbed (The practice was in this way that the researcher by applying an applicator of 15 ml Aloe Vera- Peppermint gel from a dark glass container and rubbing it on the skin of the patient) twice daily (at 9 and 21 o’clock) on pressure points (hip, sacrum, heels) and were given 2–3 min to absorb. The gel was applied for a10 day duration.
干预措施: In the experimental group, researchers first tested a part of Aloe Vera- Peppermint gel on the inner region of forearm, left for 15–30 minutes initially for immediate reactions. Then observed again at 24 hours for delayed hypersensitivity reactions and if it does not cause an allergic reaction, it was rubbed (The practice was in this way that the researcher by applying an applicator of 15 ml Aloe Vera- Peppermint gel from a dark glass container and rubbing it on the skin of the patient) twice daily (at 9 and 21 o’clock) on pressure points (hip, sacrum, heels) and were given 2–3 min to absorb. The gel was applied for a10 day duration.
Control group
In the control group, provide standardized prevention methods only that mentioned. Then, the sacrum, hip (trochanter), and heel of both groups of patients were examined on days 3, 7 and 10 in terms of presence or absence of signs of pressure injuries based on NPUAP scale.
干预措施: In the control group, provide standardized prevention methods only that mentioned. Then, the sacrum, hip (trochanter), and heel of both groups of patients were examined on days 3, 7 and 10 in terms of presence or absence of signs of pressure injuries based on NPUAP scale.
结局指标
主要结局
Incidence of pressure injuries
时间窗: 10 days
Clinical information data
次要结局
- Sociodemographic data