The Effect of Genital Hygiene Training Provided to Turkish Women Living in Rural Areas With a Vulvovaginal Candidiasis History on Genital Hygiene Behaviors and Self-care Agency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Genital Hygiene Behavior Inventory (GHBI)
研究概览
简要总结
Purpose: In the study, it was aimed to determine the effect of genital hygiene training provided to women living in rural areas with a vulvovaginal candidiasis history on genital hygiene behaviors and self-care agency.
Material and methods: This study with a randomized controlled design was conducted with the participation of women who were registered to Family Health Centers located in two villages in the rural areas in the east of Turkey and who had a history of vulvovaginal candidiasis within the last year. The study sample consisted of 114 women in total, 57 of whom were in the intervention group and 57 were in the control group. The women in the intervention group were provided with genital hygiene behaviors training. The study data were collected Identifying Information Form, Genital Hygiene Behavior Inventory (GHBI), and Self-Care Agency Scale (SCAS).
详细描述
Design The study was designed as a randomized controlled trial in which the subjects were randomly assigned to the intervention (receiving genital hygiene training) and the control group.
The study was conducted in the Family Health Centers of two randomly selected villages with a distance of 20-30 km to Van province located in the east of Turkey. These villages are in a rural area and people make their living mostly through farming. Each village had one family health center, and other health institutions were in the provincial center. Family health centers are primary care health institutions which provide reproductive health service for women (healthy woman follow-up, laboratory tests, family planning, education, counselling, etc.). While training is provided within the scope of preventive health services in family health centers, there is no training provided specifically on genital health regarding vulvovaginal candidiasis. Working hours are between 08.00-17.00 every weekday, and there are three family health doctors and three family health professionals (midwife and/or nurse) in these centers.
Sample The study sample consisted of women who tested positive on at least one culture test and received and completed treatment for vulvovaginal candidiasis in the last year according to the registry of the Family Health Centers. The study inclusion criteria were being within the age range of 18-49 years, not having a systemic disease, and not being pregnant or puerpera between the dates when the study was conducted. According to the registration system of the family health centers, 1,400 women who met these criteria were receiving service from these centers.
In order to predict the most suitable sample size for the study, priori-power analysis was performed on a web-based software (https://www.stat.ubc.ca/\~rollin/stats/ssize/n2.html). Sample size was calculated to be 57 for each group (57 in the intervention group and 57 in the control group) with 5% margin of error at two-way significance level, 95% confidence interval, 80% power of representing the population and by assuming that the mean score of genital hygiene behaviors, which was 84.51 (standard deviation 5.69), would increase by three points. According to the records of the family health centers where the study was conducted, there were 142 women who received and completed treatment for vulvovaginal candidiasis in the last six months. 142 women were assigned to the intervention and control groups through randomization. Women were listed by the researchers for randomization. According to the list, women with odd numbers were assigned to the intervention group and those with even numbers were included in the control group. The sample selection process carried out in line with CONSORT criteria is presented in Figure 1.
Data Collection Tools In the collection of the study data, Identifying Information Form, Genital Hygiene Behavior Inventory (GHBI), and Self-Care Agency Scale (SCAS) were used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 49 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women who tested positive on at least one culture test and received and treatment for vulvovaginal candidiasis in the last year according to the registry of the Family Health Centers, within the age range of 18-49 years, not having a systemic disease, and not being pregnant or puerpera between the dates when the study was conducted.
排除标准
- •Those who cannot communicate in Turkish, who are illiterate
结局指标
主要结局
Genital Hygiene Behavior Inventory (GHBI)
时间窗: Change from genital hygiene behavior levels at 4 weeks
The scale was developed in Turkish in order to measure genital hygiene behaviors of women, and the validity and reliability study of the scale was conducted by Karahan in 2017. The scale consists of three subscales, which are "general hygiene" (12 items), "menstrual hygiene" (8 items), and "abnormal finding awareness" (3 items). The 23-item and 5-point Likert type scale is scored between 1 and 5. The minimum and maximum scores to be obtained from the scale are 23 and 115. As the score obtained from the scale increases, the women's levels of displaying proper genital hygiene behaviors increase.
次要结局
- Self-Care Agency Scale (SCAS)(Change from self-care agency levels at 4 weeks)
研究者
Esra SABANCI BARANSEL
Assistant professor
Inonu University
