Effect of Primrose Oil Versus Lavender Oil on Hot Flashes and Night Sweats Among Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- frequency of hot flashes among menopausal women.
研究概览
简要总结
there is a scanty of researches which integrate to investigate the comparing effect of evening primrose oil and lavender as the essential oil that affects on menopausal vasomotor symptoms especially hot flashes and night sweet Therefore, the current study is expected to contribute to the knowledge and practice regarding the effect of lavender versus primrose oil on hot flashes and night sweat in menopausal women.
详细描述
The aim of this study is to assess the efficacy of primrose oil versus lavender oil on hot flashes and night sweats among menopausal women
Research Hypotheses To fulfill the aim of this study the following research hypotheses will be formulated H1: Menopausal women who will receive evening primrose oil may show decrease in frequency and severity of hot flashes and night sweat as compared to those who will receive routine care H2: Menopausal women who will receive lavender oil may show decrease in frequency and severity of hot flashes and night sweat as compared to those who will receive routine care H3: There is a difference between menopausal women who will receive evening primrose oil versus lavender oil in relation to frequency and severity of hot flashes and night sweat Outcome measures
Sample A total of (150) menopausal women who will attend the out patient gynaecological clinic at Obstetrics and Gynecological hospital in Cairo university hospitals, Kasr El Ainy will be recruited for this study and randomly assigned to either group who will receive primrose oil (50) women, the other group who will receive lavender oil (50) women, the placebo group (50) who will take package of oil but dosnt contain the active substance .
Tools for Data Collection To fulfill the aim of the study fourth tools will be utilized for data collection. The first one the interviewing questionnaire which was designed by the researcher through extensive review of literature; the second tool is Daily hot flash / night sweets diaries; the third tool is Hot-flush/ night sweet problem-rating (HFNS Problem Rating) and the fourth tool is Hot Flash Related Daily Interference Scale (HFRDIS).
Tools used in the Randomized Control Trail:
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
- Double (Participant, Investigator)
盲法说明
Regarding the nature of the intervention it will be double blind as the women will not know which intervention will take and the randomization of the groups will be done by person other than the researchers.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •can read and write
- •experienced amenorrhea for > 6 months
- •mild or moderate-to-severe hot flashes at least twice daily
- •normal blood pressure
- •normal kidney and liver function
- •no abnormal vaginal bleeding
- •no sensitivity to herbal substances
排除标准
- •Women with serious disease such as kidney, liver, seizure and allerg
- •use of hormonal medications or herbal treatment in the preceding 2 months for treatment of hot flushes or night sweet
结局指标
主要结局
frequency of hot flashes among menopausal women.
时间窗: Before intervention, 4 week after intervention, 8 week after intervention
it will be assessed by Daily Hot Flash Diary: It is a selfreport dairy in which participants recorded how many hot flashes they experienced on a daily basis. Hot flashes throughout a 7-day period were added to produce a weekly hot flash frequency score
to To what extent hot flash and night sweet are a problem
时间窗: Before intervention, 4 week after intervention, 8 week after intervention
This tool is standardized tool to measure the extent to which hot flash and night sweet are a problem, it is a subscale of the Hot Flush Rating Scale (HFRS) this validated self-report measure has three questions using 10-point Likert scales to rate the extent to which HFNS are problematic, distressing, and the cause of interference in daily life. Problem rating is calculated as the mean of the three questions, with higher scores indicating more problematic
severity of hot flashes among menopausal women
时间窗: Before intervention, 4 week after intervention, 8 week after intervention
it will be assessed by Daily Hot Flash Diaryas well as the severity of each hot flash on a scale of 1-3 (1 being mild, 2 moderate, and 3 severe). the number of hot flashes reported in each severity level was used to calculate the daily severity score, the total number of daily severity scores over the course of seven days was used to determine the hot flash severity index. The hot flash severity score for each day was calculated as the sum of the number of hot flashes within each severity category, multiplied by the severity score for that category, with the resulting sum divided by the total number of hot flashes
次要结局
- Hot Flash Related Daily Interference(Before intervention, 4 week after intervention, 8 week after intervention)
研究者
Fatma Zaghloul
Lecturer of maternal and newborn health nursing
Cairo University