xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05988242</url>
    </required_header>
    <id_info>
      <org_study_id>Lavender and Primrose</org_study_id>
      <nct_id>NCT05988242</nct_id>
    </id_info>
    <brief_title>Effect of Lavender Versus Primrose Oil on Menopause Symptom</brief_title>
    <official_title>Effect of Primrose Oil Versus Lavender Oil on Hot Flashes and Night Sweats Among Menopausal Women</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        there is a scanty of researches which integrate to investigate the comparing effect of&#xD;
        evening primrose oil and lavender as the essential oil that affects on menopausal vasomotor&#xD;
        symptoms especially hot flashes and night sweet Therefore, the current study is expected to&#xD;
        contribute to the knowledge and practice regarding the effect of lavender versus primrose oil&#xD;
        on hot flashes and night sweat in menopausal women.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of this study is to assess the efficacy of primrose oil versus lavender oil on hot&#xD;
        flashes and night sweats among menopausal women&#xD;
  &#xD;
        Research Hypotheses To fulfill the aim of this study the following research hypotheses will&#xD;
        be formulated H1: Menopausal women who will receive evening primrose oil may show decrease in&#xD;
        frequency and severity of hot flashes and night sweat as compared to those who will receive&#xD;
        routine care H2: Menopausal women who will receive lavender oil may show decrease in&#xD;
        frequency and severity of hot flashes and night sweat as compared to those who will receive&#xD;
        routine care H3: There is a difference between menopausal women who will receive evening&#xD;
        primrose oil versus lavender oil in relation to frequency and severity of hot flashes and&#xD;
        night sweat Outcome measures&#xD;
  &#xD;
        Sample A total of (150) menopausal women who will attend the out patient gynaecological&#xD;
        clinic at Obstetrics and Gynecological hospital in Cairo university hospitals, Kasr El Ainy&#xD;
        will be recruited for this study and randomly assigned to either group who will receive&#xD;
        primrose oil (50) women, the other group who will receive lavender oil (50) women, the&#xD;
        placebo group (50) who will take package of oil but dosnt contain the active substance .&#xD;
  &#xD;
        Tools for Data Collection To fulfill the aim of the study fourth tools will be utilized for&#xD;
        data collection. The first one the interviewing questionnaire which was designed by the&#xD;
        researcher through extensive review of literature; the second tool is Daily hot flash / night&#xD;
        sweets diaries; the third tool is Hot-flush/ night sweet problem-rating (HFNS Problem Rating)&#xD;
        and the fourth tool is Hot Flash Related Daily Interference Scale (HFRDIS).&#xD;
  &#xD;
        Tools used in the Randomized Control Trail:&#xD;
  &#xD;
        First tool: Interviewing Questionnaires Schedule (Appendix A) This tool designed by the&#xD;
        researcher after extensive literature review which constituted of four parts; first part data&#xD;
        related to demographic characteristics such as age, level of education, residence and&#xD;
        occupation. Second part data related to menstrual history and menopausal status.&#xD;
  &#xD;
        Second tool: Daily hot flash / night sweets diaries Daily Hot Flash Diary: It is a selfreport&#xD;
        dairy , in which participants recorded how many hot flashes they experienced on a daily basis&#xD;
        as well as the severity of each hot flash on a scale of 1-3 (1 being mild, 2 moderate, and 3&#xD;
        severe). Hot flashes throughout a 7-day period were added to produce a weekly hot flash&#xD;
        frequency score. While the number of hot flashes reported in each severity level was used to&#xD;
        calculate the daily severity score, the total number of daily severity scores over the course&#xD;
        of seven days was used to determine the hot flash severity index The hot flash severity score&#xD;
        for each day was calculated as the sum of the number of hot flashes within each severity&#xD;
        category, multiplied by the severity score for that category, with the resulting sum divided&#xD;
        by the total number of hot flashes Third tool: Hot-flush/ night sweet problem-rating (HFNS&#xD;
        Problem Rating) This tool is standardized tool to measure the extent to which HFNS are a&#xD;
        problem, it is a subscale of the Hot Flush Rating Scale (HFRS) this validated self-report&#xD;
        measure has three questions using 10-point Likert scales to rate the extent to which HFNS are&#xD;
        problematic, distressing, and the cause of interference in daily life. Problem rating is&#xD;
        calculated as the mean of the three questions, with higher scores indicating more&#xD;
        problematic. This tool has significant correlations with diary recordings for hot flushes&#xD;
        (r=0.97, p&lt;0.001) and night sweats (r=0.94, p&lt;0.001). HFRS has good test-retest reliability&#xD;
        (r=0.8) and internal consistency (alpha=0.87); the internal reliability alpha coefficients&#xD;
        0.84. it is significantly associated (r=0.61-0.85 p&lt;0.001) .&#xD;
  &#xD;
        Fourth tool: Hot Flash Related Daily Interference Scale (HFRDIS) It is a 10-item scale to&#xD;
        assess the degree to which hot flashes interfere with women's daily life activities. The&#xD;
        first nine items assess the quality of daily life activities including work, social&#xD;
        activities, leisure activities, sleep, mood, concentration, relationships with others,&#xD;
        sexuality, and enjoyment of life and the tenth item assesses the overall quality of life. On&#xD;
        a scale of 0 (do not interfere) to 10 (totally interfere), Women rate the extent to which hot&#xD;
        flashes interfered with each item throughout the previous week. A total score is calculated&#xD;
        by summing items. Higher scores reflect more interference from hot flashes and a greater&#xD;
        impact on quality of life. The total score ranges from 0-100. This score was interpreted to&#xD;
        the Mild interference 0-33•corresponding daily interference as follows: Moderate interference&#xD;
        34-67• Severe interference 68-100• Validity and reliability&#xD;
  &#xD;
        Tools of data collection are standardized tool..UN standardized tools were submitted to 3&#xD;
        experts in the field of maternity nursing to test content validity, clarity of sentences and&#xD;
        an appropriateness of content. Modifications were carried out according to the expert&#xD;
        judgment before seeking the acceptance of ethical committee.&#xD;
  &#xD;
        Ethical consideration An official approval to conduct the proposed study will be obtained&#xD;
        from the Research Ethics Committee at faculty of nursing - Cairo University. As well, an&#xD;
        official permission will be taken from the administrative personnel in the recommended&#xD;
        settings. Also, each woman will be informed orally about the purpose of the trial and its&#xD;
        importance. In addition, informed written consent will be obtained from women who will be&#xD;
        willing to participate in the trial after ensuring that their participation in the trial will&#xD;
        be voluntary and can be withdrawing at any time. As well as the anonymity, confidentiality&#xD;
        and privacy of the information will be maintained.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 20, 2022</start_date>
    <completion_date type="Actual">July 20, 2023</completion_date>
    <primary_completion_date type="Actual">April 21, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <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).</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>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.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>frequency of hot flashes among menopausal women.</measure>
      <time_frame>Before intervention, 4 week after intervention, 8 week after intervention</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>severity of hot flashes among menopausal women</measure>
      <time_frame>Before intervention, 4 week after intervention, 8 week after intervention</time_frame>
      <description>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.&#xD;
  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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>to To what extent hot flash and night sweet are a problem</measure>
      <time_frame>Before intervention, 4 week after intervention, 8 week after intervention</time_frame>
      <description>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</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hot Flash Related Daily Interference</measure>
      <time_frame>Before intervention, 4 week after intervention, 8 week after intervention</time_frame>
      <description>It is a 10-item scale developed by Carpenter, (2001) 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•</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">3</enrollment>
    <condition>Menopause Syndrome</condition>
    <arm_group>
      <arm_group_label>primrose oil</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>primrose oil</description>
    </arm_group>
    <arm_group>
      <arm_group_label>lavender oil</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>lavender oil</description>
    </arm_group>
    <arm_group>
      <arm_group_label>the placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>took the same bottle of oil which didn't contain the active substances but have the same shape, same oder, same color.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Primrose oil</intervention_name>
      <description>group A will take primrose oil</description>
      <arm_group_label>primrose oil</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Lavender oil</intervention_name>
      <description>group B will take lavender oil</description>
      <arm_group_label>lavender oil</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>placcebo</intervention_name>
      <description>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</description>
      <arm_group_label>the placebo group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  can read and write&#xD;
  &#xD;
            -  experienced amenorrhea for &gt; 6 months&#xD;
  &#xD;
            -  mild or moderate-to-severe hot flashes at least twice daily&#xD;
  &#xD;
            -  normal blood pressure&#xD;
  &#xD;
            -  normal kidney and liver function&#xD;
  &#xD;
            -  no abnormal vaginal bleeding&#xD;
  &#xD;
            -  no sensitivity to herbal substances&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women with serious disease such as kidney, liver, seizure and allerg&#xD;
  &#xD;
            -  use of hormonal medications or herbal treatment in the preceding 2 months for&#xD;
               treatment of hot flushes or night sweet&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lamiaa Saad, lecturer</last_name>
      <role>Study Chair</role>
      <affiliation>faculty of nursing</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Faculty of nursinf</name>
        <address>
          <city>Cairo</city>
          <zip>12519</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Kazemi F, Masoumi SZ, Shayan A, Oshvandi K. The Effect of Evening Primrose Oil Capsule on Hot Flashes and Night Sweats in Postmenopausal Women: A Single-Blind Randomized Controlled Trial. J Menopausal Med. 2021 Apr;27(1):8-14. doi: 10.6118/jmm.20033.</citation>
      <PMID>33942584</PMID>
    </reference>
    <reference>
      <citation>Farzaneh F, Fatehi S, Sohrabi MR, Alizadeh K. The effect of oral evening primrose oil on menopausal hot flashes: a randomized clinical trial. Arch Gynecol Obstet. 2013 Nov;288(5):1075-9. doi: 10.1007/s00404-013-2852-6. Epub 2013 Apr 27.</citation>
      <PMID>23625331</PMID>
    </reference>
    <reference>
      <citation>Reddi KK. Human granulocyte ribonuclease. Biochem Biophys Res Commun. 1976 Feb 23;68(4):1119-25. doi: 10.1016/0006-291x(76)90312-0. No abstract available.</citation>
      <PMID>5077</PMID>
    </reference>
    <reference>
      <citation>Baker FC, Lampio L, Saaresranta T, Polo-Kantola P. Sleep and Sleep Disorders in the Menopausal Transition. Sleep Med Clin. 2018 Sep;13(3):443-456. doi: 10.1016/j.jsmc.2018.04.011.</citation>
      <PMID>30098758</PMID>
    </reference>
    <reference>
      <citation>Carreiras M, Seghier ML, Baquero S, Estevez A, Lozano A, Devlin JT, Price CJ. An anatomical signature for literacy. Nature. 2009 Oct 15;461(7266):983-6. doi: 10.1038/nature08461.</citation>
      <PMID>19829380</PMID>
    </reference>
    <reference>
      <citation>Mehrpooya M, Rabiee S, Larki-Harchegani A, Fallahian AM, Moradi A, Ataei S, Javad MT. A comparative study on the effect of &quot;black cohosh&quot; and &quot;evening primrose oil&quot; on menopausal hot flashes. J Educ Health Promot. 2018 Mar 1;7:36. doi: 10.4103/jehp.jehp_81_17. eCollection 2018.</citation>
      <PMID>29619387</PMID>
    </reference>
    <reference>
      <citation>Green MR, Pastewka JV. The cationic carbocyanine dyes Stains-all DBTC, and Ethyl-Stains-all, DBTC-3,3',9 triethyl. J Histochem Cytochem. 1979 Mar;27(3):797-9. doi: 10.1177/27.3.90067.</citation>
      <PMID>90067</PMID>
    </reference>
    <results_reference>
      <citation>Tsai J, Chung YC, Chen FP, Yeh ML. [Effect of Aromatherapy on Menopausal Symptoms, Heart Rate Variability, and Sleep Quality in Women]. Hu Li Za Zhi. 2020 Feb;67(1):44-54. doi: 10.6224/JN.202002_67(1).07. Chinese.</citation>
      <PMID>31960396</PMID>
    </results_reference>
    <results_reference>
      <citation>Kazemzadeh R, Nikjou R, Rostamnegad M, Norouzi H. Effect of lavender aromatherapy on menopause hot flushing: A crossover randomized clinical trial. J Chin Med Assoc. 2016 Sep;79(9):489-92. doi: 10.1016/j.jcma.2016.01.020. Epub 2016 Jul 4.</citation>
      <PMID>27388435</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Fatma Zaghloul</investigator_full_name>
      <investigator_title>Lecturer of maternal and newborn health nursing</investigator_title>
    </responsible_party>
    <keyword>Hot Flashes</keyword>
    <keyword>Sweat</keyword>
    <keyword>Menopause</keyword>
    <keyword>Lavandula</keyword>
    <keyword>Primula</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>the data will be shared online</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>four month</ipd_time_frame>
      <ipd_access_criteria>will be published on magazine</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05988242
  org study id: Lavender and Primrose
  nct id: NCT05988242
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  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).
  primary purpose: Supportive Care
  masking: Double (Participant, Investigator)
  masking description: 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.
  measure: frequency of hot flashes among menopausal women.
  time frame: Before intervention, 4 week after intervention, 8 week after intervention
  description: 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
  measure: severity of hot flashes among menopausal women
  time frame: Before intervention, 4 week after intervention, 8 week after intervention
  description: 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
  measure: to To what extent hot flash and night sweet are a problem
  time frame: Before intervention, 4 week after intervention, 8 week after intervention
  description: 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
  measure: Hot Flash Related Daily Interference
  time frame: Before intervention, 4 week after intervention, 8 week after intervention
  description: It is a 10-item scale developed by Carpenter, (2001) 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•
  arm group label: primrose oil
  arm group type: Experimental
  description: primrose oil
  arm group label: lavender oil
  arm group type: Experimental
  description: lavender oil
  arm group label: the placebo group
  arm group type: Placebo Comparator
  description: took the same bottle of oil which didn't contain the active substances but have the same shape, same oder, same color.
  intervention type: Other
  intervention name: Primrose oil
  description: group A will take primrose oil
  arm group label: primrose oil
  intervention type: Other
  intervention name: Lavender oil
  description: group B will take lavender oil
  arm group label: lavender oil
  intervention type: Other
  intervention name: placcebo
  description: 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
  arm group label: the placebo group
  criteria: 
  gender: Female
  minimum age: 40 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lamiaa Saad, lecturer
  role: Study Chair
  affiliation: faculty of nursing
  facility: 
  country: Egypt
  citation: Kazemi F, Masoumi SZ, Shayan A, Oshvandi K. The Effect of Evening Primrose Oil Capsule on Hot Flashes and Night Sweats in Postmenopausal Women: A Single-Blind Randomized Controlled Trial. J Menopausal Med. 2021 Apr;27(1):8-14. doi: 10.6118/jmm.20033.
  PMID: 33942584
  citation: Farzaneh F, Fatehi S, Sohrabi MR, Alizadeh K. The effect of oral evening primrose oil on menopausal hot flashes: a randomized clinical trial. Arch Gynecol Obstet. 2013 Nov;288(5):1075-9. doi: 10.1007/s00404-013-2852-6. Epub 2013 Apr 27.
  PMID: 23625331
  citation: Reddi KK. Human granulocyte ribonuclease. Biochem Biophys Res Commun. 1976 Feb 23;68(4):1119-25. doi: 10.1016/0006-291x(76)90312-0. No abstract available.
  PMID: 5077
  citation: Baker FC, Lampio L, Saaresranta T, Polo-Kantola P. Sleep and Sleep Disorders in the Menopausal Transition. Sleep Med Clin. 2018 Sep;13(3):443-456. doi: 10.1016/j.jsmc.2018.04.011.
  PMID: 30098758
  citation: Carreiras M, Seghier ML, Baquero S, Estevez A, Lozano A, Devlin JT, Price CJ. An anatomical signature for literacy. Nature. 2009 Oct 15;461(7266):983-6. doi: 10.1038/nature08461.
  PMID: 19829380
  citation: Mehrpooya M, Rabiee S, Larki-Harchegani A, Fallahian AM, Moradi A, Ataei S, Javad MT. A comparative study on the effect of "black cohosh" and "evening primrose oil" on menopausal hot flashes. J Educ Health Promot. 2018 Mar 1;7:36. doi: 10.4103/jehp.jehp_81_17. eCollection 2018.
  PMID: 29619387
  citation: Green MR, Pastewka JV. The cationic carbocyanine dyes Stains-all DBTC, and Ethyl-Stains-all, DBTC-3,3',9 triethyl. J Histochem Cytochem. 1979 Mar;27(3):797-9. doi: 10.1177/27.3.90067.
  PMID: 90067
  citation: Tsai J, Chung YC, Chen FP, Yeh ML. [Effect of Aromatherapy on Menopausal Symptoms, Heart Rate Variability, and Sleep Quality in Women]. Hu Li Za Zhi. 2020 Feb;67(1):44-54. doi: 10.6224/JN.202002_67(1).07. Chinese.
  PMID: 31960396
  citation: Kazemzadeh R, Nikjou R, Rostamnegad M, Norouzi H. Effect of lavender aromatherapy on menopause hot flushing: A crossover randomized clinical trial. J Chin Med Assoc. 2016 Sep;79(9):489-92. doi: 10.1016/j.jcma.2016.01.020. Epub 2016 Jul 4.
  PMID: 27388435
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Fatma Zaghloul
  investigator title: Lecturer of maternal and newborn health nursing
  sharing ipd: Yes
  ipd description: the data will be shared online
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: four month
  ipd access criteria: will be published on magazine