The Effect Of Using Coconut Oil And Moisturizing Lotion In Moisturizing The Skin Of Premature Newborns On Skin Condition And Vital Signs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Infant Information and Monitoring Form (Appendix 1):
研究概览
简要总结
Hypothesis H01: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on skin condition assessment scores.
Hypothesis H02: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on pH values.
Hypothesis H03: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on skin moisture levels.
Hypothesis H04: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on body temperature values.
Hypothesis H05: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on pulse values. Hypothesis H06: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on saturation values.
详细描述
This study is designed as a randomized controlled trial. The study will include three groups: two intervention groups and one control group. Infants meeting the inclusion criteria will be allocated to the groups using a simple randomization method. The study will be conducted between September 16, 2024, and March 16, 2025 (6 months) with 32-37-week premature infants admitted to the Intensive Care Unit of Democracy University Buca Seyfi Demirsoy Training and Research Hospital in Izmir.
There are three groups: Study Group 1 (moisturizing lotion [Muslera®]) (n=30), Study Group 2 (coconut oil) (n=30), and Control Group (n=30). In the intervention groups, moisturizing lotion or coconut oil will be applied to the infants' skin, whereas infants in the control group will receive routine skincare provided in the ward.
Portable devices will be used to measure skin pH (Ph-Meter 98218) and moisture (Elitech GSP-6 Dual-Cable Temperature and Humidity Measurement Data Logger). These devices measure skin moisture and pH through contact and have no harmful effects on the human body.
Kolmogorov-Smirnov or Shapiro-Wilk tests will be used to assess the normality of the data. Descriptive statistical analyses (number, percentage, mean, standard deviation, etc.), chi-square test, Student's t-test or Mann-Whitney U test for comparisons between two groups, and one-way analysis of variance (ANOVA) or Kruskal-Wallis H test for comparisons among three groups will be used. Pearson or Spearman correlation analyses will be conducted to evaluate the relationships between continuous variables (Büyüköztürk, 2017). A p-value of <0.05 will be considered statistically significant.
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
- 32 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Babies with a gestational age between 320/7 and 376/7 weeks,
- •Babies with a birth weight of 1500 grams or more will be included.
排除标准
- •Infants who: • are receiving invasive or non-invasive mechanical ventilation support,
- •are receiving oxygen support at a concentration greater than 23-25% in the incubator,
- •have a major congenital anomaly on the skin surface,
- •have a high infection or risk of infection due to surgery,
- •have a congenital anomaly,
- •have a skin disease/problem covering more than 5% of their body surface will not be included.
研究组 & 干预措施
Moisturizing Lotion
- Intervention Group 1 (Moisturizing Lotion)
- The application and data collection will be carried out by Nurse Zehra SÖZKESEN, who works in the neonatal intensive care unit where the research will be conducted. The research will last 5 days for each baby. Measurements will be taken before and after the application (15 minutes after application).
- Before the application, the parent will be consulted and an "Informed Consent Form" will be completed.
- Applications will be performed in a way that does not disrupt the ward routine and will be carried out after daily care during routine care hours, between 09:00-10:00 in the morning.
- The lotion to be used for babies included in the moisturizing lotion group will be kept at the patient's bedside with a barcode label attached to each patient, and a separate sterile container of lotion will be used for each patient.
- Before the application, the researcher will wash their hands according to the hospital's procedur
干预措施: Moisturizing Lotion (Behavioral)
Coconut Oil Group
Intervention Group 2 (Coconut Oil Group)
- The application and data collection will be carried out by Nurse Zehra SÖZKESEN, who works in the neonatal intensive care unit where the research will be conducted. The research will last 5 days for each baby. Measurements will be taken before and after the application (15 minutes after the application).
- Before the application, the parent will be consulted and an "Informed Consent Form" will be completed.
- Applications will be performed in a way that does not disrupt the ward routine and will be carried out after daily care between 09:00-10:00 in the morning, which are routine care hours.
- The oil to be used for babies included in the coconut oil group will be kept at the patient's bedside with a barcode label attached to each patient and will be used in a separate sterile container for each patient.
- Before the application, the researcher will wash their hands according to the hospital's procedure.
干预措施: Oil Application (Behavioral)
结局指标
主要结局
Infant Information and Monitoring Form (Appendix 1):
时间窗: five days
The Infant Information Form is an 8-question form prepared by researchers using literature. The form includes information on the baby's demographic characteristics, gender, gestational age at birth and corrected gestational age, mode of delivery, birth weight, head circumference, medical diagnosis, and feeding type. Additionally, a table is included at the bottom of the form for recording the baby's body temperature, heart rate, oxygen saturation, skin moisture, and skin pH before and for 5 days after the procedure.
Neonatal Skin Status Assessment (Appendix 2):
时间窗: five days
This scale, developed by Lund and Osborne (2004), is used to assess the skin status of healthy or sick preterm, term, and postterm newborns. The newborn's skin status is scored based on the presence of redness, dryness, and impaired skin integrity/peeling. It is developed as a three-point Likert scale, with each item/finding given a score from 1 to 3. The lowest possible score is 3, and the highest is 9. A total score higher than 3 indicates a risk of impaired skin integrity in the newborn, while a higher score indicates poor skin status. The reliability of the scale has been reported by researchers to be between 0.66 and 0.89.
次要结局
未报告次要终点
研究者
Bircan Kahraman Berberoglu
doctor
Aydin Adnan Menderes University