Clinical trial NCT05988242: Effect of Lavender Versus Primrose Oil on Menopause Symptom
Official title: Effect of Primrose Oil Versus Lavender Oil on Hot Flashes and Night Sweats Among Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause Syndrome
Keywords: Hot Flashes
Sweat
Menopause
Lavandula
Primula
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 3
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: frequency of hot flashes among menopausal women.
timeFrame: Before intervention, 4 week after intervention, 8 week after intervention
measure: severity of hot flashes among menopausal women
timeFrame: Before intervention, 4 week after intervention, 8 week after intervention
measure: to To what extent hot flash and night sweet are a problem
timeFrame: Before intervention, 4 week after intervention, 8 week after intervention
Secondary outcomes:
measure: Hot Flash Related Daily Interference
timeFrame: Before intervention, 4 week after intervention, 8 week after intervention
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of nursinf
Study officials:
affiliation: faculty of nursing
name: Lamiaa Saad, lecturer
role: STUDY_CHAIR
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