The Effect of Olive Oil on Striae Gravidarum in Primiparous Women: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 4
- 主要终点
- The Fitzpatrick Skin Type Scale
研究概览
简要总结
The aim of this study was to investigate the clinical efficacy of olive oil on the severity and progression of striae gravidarum. This randomized controlled clinical trial included 156 primipara women who were early third trimester. They were randomly allocated into two groups: an experimental group and a control group. Women in the experimental group applied olive oil to their abdomen twice a day in the morning and evening. The control group had no intervention.
详细描述
The development of striae is one of the most common skin changes in pregnancy. The aim of this study was to investigate the clinical efficacy of olive oil on the severity and progression of striae gravidarum.
This randomized controlled clinical trial included 156 primipara women who were early third trimester. They were randomly allocated into two groups: an experimental group and a control group. Women in the experimental group applied olive oil to their abdomen twice a day in the morning and evening. The control group had no intervention.Data were collected using maternal information form, Fitzpatrick Skin Type Scale and Davey's Severity Score.
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
- Double (Participant, Care Provider)
盲法说明
This study was a randomized controlled clinical trial. To avoid bias, an impartial midwife who was working in the outpatient clinic on the day the data were collected and was not among the researchers asked each participant to select one of two closed envelopes that included the letters A (experimental group) or B (control group). The pregnant women were assigned to the experimental and control groups depending on the letter in the envelope they chose. Then, the researcher registered the participants in the experimental and control groups on a list. The obstetrician and pregnant women were informed about the procedure, but the obstetrician did not know which procedure would be applied to which pregnant woman. The pregnant women did not know why olive oil was being used. The participating women signed an informed consent form knowing that they could withdraw from the study at any time
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •being in the age group of 20-30 years, early third trimester (being at the 28th week of gestation), having a singleton pregnancy, being primiparous, and volunteering to participate in the study.
排除标准
- •having a chronic disease (such as diabetes or hypertension), having striae (before 28th gestation week), having traces of scar tissue from adolescence, using cortisone cream or another kind of topical cream, having polyhydramnios, having threatened preterm labor or preterm delivery, having any disease of the skin, taking any medication regularly, having a problem preventing communication, using pharmacological or non-pharmacological methods (undergoing pharmacotherapy) to reduce nausea, and undergoing psychiatric treatment (psychotherapy).
结局指标
主要结局
The Fitzpatrick Skin Type Scale
时间窗: All the participating women were followed-up from the 28th week of gestation to the 37th week of gestation.
The Fitzpatrick Skin Type Scale was developed by Fitzpatrick in 1975 to classify skin type.This scale uses genetic structure, eye color, reaction to sunlight to assign a skin type. According to the scale, the skin types vary from the extremely sensitive type, which always burns and does not tan, to the sun-resistant type, which is darkly pigmen and response to sunlight.
Davey's Severity Score
时间窗: All the participating women were followed-up from the 28th week of gestation to the 37th week of gestation.
Davey's Severity Score is a scoring method developed by Davey in 1972 to measure the severity of SG.It divides the abdomen into four equal quadrants. Each quadrant is rated as "0" for clean skin, "1" for moderate striae, and "2" for multiple striae. Accordingly, the total score ranges from 0 to 8.
Prevent the severity and progression of SG
时间窗: All the participating women were followed-up from the 28th week of gestation to the 37th week of gestation.
The participants completed the Maternal Information Forms through face-to-face interviews with an unbiased midwife who was working in the outpatient clinic on the day the data were collected.The women in the experimental group were asked to apply 10 cc (4 tablespoons) of extra virgin olive oil to the entire abdomen by hand without massaging twice a day in the morning and evening. The control group did not undergo any intervention. The women were called via telephone by the researcher once a week and asked whether they were performing the application. Women who were not applying the olive oil or who were using other medicines or creams (at least three days a week) were excluded from the study. The women in the control group were asked whether they were performing any applications. Those who were applying any products were also excluded. The striae was evaluated all groups at 37 weeks of gestation based on the Fitzpatrick Skin Type Scale and Davey's Severity Score by obstetrician.
Maternal information form
时间窗: All the participating women were followed-up from the 28th week of gestation to the 37th week of gestation.
The Maternal Information Form was used to select whether pregnant women met the study.This form, which was developed by the researchers in line with knowledge of the literature, included 30 items questioning the participants' sociodemographic ch criteria.
次要结局
未报告次要终点
研究者
Ayca Solt Kirca
Assistant Professor
Kırklareli University