Effect of Lavender Versus Primrose Oil on Menopause Symptom
Condition: Menopause Syndrome
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

      First tool: Interviewing Questionnaires Schedule (Appendix A) This tool designed by the
      researcher after extensive literature review which constituted of four parts; first part data
      related to demographic characteristics such as age, level of education, residence and
      occupation. Second part data related to menstrual history and menopausal status.

      Second tool: Daily hot flash / night sweets diaries Daily Hot Flash Diary: It is a selfreport
      dairy , in which participants recorded how many hot flashes they experienced on a daily basis
      as well as the severity of each hot flash on a scale of 1-3 (1 being mild, 2 moderate, and 3
      severe). Hot flashes throughout a 7-day period were added to produce a weekly hot flash
      frequency score. While 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 Third tool: Hot-flush/ night sweet problem-rating (HFNS
      Problem Rating) This tool is standardized tool to measure the extent to which HFNS 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. This tool has significant correlations with diary recordings for hot flushes
      (r=0.97, p<0.001) and night sweats (r=0.94, p<0.001). HFRS has good test-retest reliability
      (r=0.8) and internal consistency (alpha=0.87); the internal reliability alpha coefficients
      0.84. it is significantly associated (r=0.61-0.85 p<0.001) .

      Fourth tool: Hot Flash Related Daily Interference Scale (HFRDIS) It is a 10-item scale to
      assess the degree to which hot flashes interfere with women's daily life activities. The
      first nine items assess the quality of daily life activities including work, social
      activities, leisure activities, sleep, mood, concentration, relationships with others,
      sexuality, and enjoyment of life and the tenth item assesses the overall quality of life. On
      a scale of 0 (do not interfere) to 10 (totally interfere), Women rate the extent to which hot
      flashes interfered with each item throughout the previous week. A total score is calculated
      by summing items. Higher scores reflect more interference from hot flashes and a greater
      impact on quality of life. The total score ranges from 0-100. This score was interpreted to
      the Mild interference 0-33•corresponding daily interference as follows: Moderate interference
      34-67• Severe interference 68-100• Validity and reliability

      Tools of data collection are standardized tool..UN standardized tools were submitted to 3
      experts in the field of maternity nursing to test content validity, clarity of sentences and
      an appropriateness of content. Modifications were carried out according to the expert
      judgment before seeking the acceptance of ethical committee.

      Ethical consideration An official approval to conduct the proposed study will be obtained
      from the Research Ethics Committee at faculty of nursing - Cairo University. As well, an
      official permission will be taken from the administrative personnel in the recommended
      settings. Also, each woman will be informed orally about the purpose of the trial and its
      importance. In addition, informed written consent will be obtained from women who will be
      willing to participate in the trial after ensuring that their participation in the trial will
      be voluntary and can be withdrawing at any time. As well as the anonymity, confidentiality
      and privacy of the information will be maintained.
    

Intervention name(s): Primrose oil; Lavender oil; placcebo
Intervention type(s): Other; Other; Other
Intervention description(s): group A will take primrose oil; group B will take lavender oil; this is the comparator group who will take the same bottle of oil which dosnt contain the active substances but have the sampe shape, same oder, same color
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel randomized controlled trial will be used to fulfill the aim of proposed study. The randomized control trial (RCT) is a trial in which subjects are randomly assigned to one of two or more groups: the intervention (group A) who will receive evening primrose oil, the intervention (group B) who will receive lavender oil, the third group ( C) who will receive placebo (Spieth et al, 2016).
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Hot Flashes; Sweat; Menopause; Lavandula; Primula