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/NCT06035380</url>
    </required_header>
    <id_info>
      <org_study_id>EasternMU-SBF-HB-GMAD-01</org_study_id>
      <nct_id>NCT06035380</nct_id>
    </id_info>
    <brief_title>The Effect of Aromatherapy to Women With Vasomotor Complaints on Menopausal Quality of Life and Vasomotor Symptoms</brief_title>
    <acronym>Aromatherapy</acronym>
    <official_title>The Effect of Aromatherapy to Women With Vasomotor Complaints on Menopausal Quality</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eastern Mediterranean University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Eastern Mediterranean 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>
        Evaluation of the effect of aromatherapy applied to women with vasomotor complaints on&#xD;
        menopausal quality of life and vasomotor symptoms.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Menopause, ovarian failure due to loss of follicular function of the ovaries accompanied by&#xD;
        estrogen deficiency, causes permanent cessation of menstruation and loss of reproductive&#xD;
        function. The period in which irregularities in the menstrual cycle begin to appear and the&#xD;
        chance of fertility decreases is defined as the premenopausal period. During this period,&#xD;
        vasomotor complaints occur. vasomotor complaints; It is reported as hot flashes, sweating and&#xD;
        night sweats . It has been reported that women experience an average of 4-5 hot flashes per&#xD;
        day , and this number reaches 20 in some women . These changes are usually the most severe&#xD;
        and disturbing findings two or three years before menopause and can continue in later years .&#xD;
        Studies have reported that vasomotor complaints negatively affect women's quality of life.&#xD;
  &#xD;
        Application methods of aromatherapy with many therapeutic benefits, massage oil, face&#xD;
        cream/oil, gel, body bath, hand and foot baths, compresses, hot towels, aromatic sprays, bath&#xD;
        salt, inhalations (direct bottle, sniffing salt, drip on handkerchief), steam inhalation,&#xD;
        facial mist, diffusion (diffuser, nebulizer, candle), ointment, mouthwash . Studies have also&#xD;
        reported that aromatherapy methods used during menopause reduce vasomotor complaints and&#xD;
        positively affect quality of life .&#xD;
  &#xD;
        Evaluating and supporting women in line with the holistic nursing approach is among the&#xD;
        responsibilities of nurses. Nurses' development of appropriate care standards in line with&#xD;
        these goals constitutes an important step for women to step into a healthy and high-quality&#xD;
        old age. Women's health nurses should provide care, counseling and training to increase the&#xD;
        quality of life of women who spend one-third of their life in the menopausal period .&#xD;
  &#xD;
        Studies have reported that aromatherapy has a positive effect on quality of life. However,&#xD;
        studies on this subject in Türkiye and the Turkish Republic of Northern Cyprus are quite&#xD;
        limited.&#xD;
  &#xD;
        Purpose of the research; This study will be conducted to evaluate the effect of aromatherapy&#xD;
        applied to women with vasomotor complaints on menopausal quality of life and vasomotor&#xD;
        symptoms.&#xD;
  &#xD;
        The population of the study will consist of women living in the Turkish Republic of Northern&#xD;
        Cyprus, Famagusta District and reporting more than 5 vasomotor complaints according to the&#xD;
        Visual Analog Scale. The sample size was determined as 66 by G*Power analysis. Three groups&#xD;
        will be formed by randomization method from the people who agreed to participate in the&#xD;
        study, while rose oil will be used in the first group, peppermint oil will be used in the&#xD;
        second group, and the third group will form the placebo group.&#xD;
  &#xD;
        Essential oils to be used in groups to be treated with aromatherapy are rose and mint oils.&#xD;
        In addition to the cooling effect of rose oil, it is known that thanks to its pleasant smell,&#xD;
        it helps the user to feel good and is also effective in reducing menopausal symptoms. At the&#xD;
        same time, peppermint oil is stated to revitalize the body, increase energy level, provide&#xD;
        refreshment and reduce menopausal symptoms . It will be used after diluting by adding 10 ml&#xD;
        of black cumin oil as carrier oil to 2 drops of rose and mint oils to be used in the study.&#xD;
  &#xD;
        In 2021, the researcher completed the 90-hour theoretical and 16-hour applied aromatherapy&#xD;
        training program, coordinated by Riccon Academy-Bern-Schweiz and Adamer training center, and&#xD;
        received her certificate.&#xD;
  &#xD;
        The placebo group will be asked to use the spray whenever they complain of hot flashes, using&#xD;
        drinking water.&#xD;
  &#xD;
        With this randomized controlled study, it is aimed to evaluate the effect of aromatherapy&#xD;
        applied to women with vasomotor complaints on menopausal quality of life and vasomotor&#xD;
        symptoms, and to provide evidence for the care to be offered to menopausal women.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 30, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 1, 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>randomized controlled trial</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>VISUAL ANALOGUE SCALE (VAS)</measure>
      <time_frame>Baseline, 1 day</time_frame>
      <description>VAS is used to convert some values that cannot be measured numerically. This scale is a safe, easily applicable test that has proven itself for a very long time and has been accepted in all the world literature. The test has no language and its ease of implementation is an important advantage. It was used in this study to determine how much hot flashes complaints experienced by women affect their lives. It was explained to the women that one end of the scale did not affect their life at all (0), and that it affected their life too much as they approached the other end (10). The women were asked to mark the number on a divided line with numbers from 0 to 10, and how much they thought their hot flashes had affected their lives.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Introductory Information Form</measure>
      <time_frame>Baseline, 1 day</time_frame>
      <description>women's socio-demographic characteristics , physical characteristics , pregnancy and birth information (pregnancy). number of people living together, spousal support, menstrual pattern, last menstrual period, age of mother's menopause, chronic diseases, smoking and alcohol use, vasomotor complaints, use of CAM and nursing support are included in a total of 27 questions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hot Flashes Scale Specific to Menopause</measure>
      <time_frame>Baseline, 1 day, the ninetieth day</time_frame>
      <description>The Menopause-Specific Hot Flashes Scale is used to measure the effect of hot flashes on overall quality of life (item 10) and nine specific activities (item 1-item 9). Nine specific activities: work, social activities, leisure activities, sleep, mood, concentration, relationships with others, sexuality, enjoyment of life. How much hot flashes affect the woman's life during the last two weeks is evaluated by numerical rating method from 0 to 10. A value of 0 means &quot;not at all affected&quot; and a value of 10 means &quot;very much affected&quot;. The total score is calculated by adding the numerical values of each item.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Menopause-Specific Quality of Life Scale</measure>
      <time_frame>Baseline, 1 day, the ninetieth day</time_frame>
      <description>It is a 29-item Likert-type scale. The scale consists of four domains: vasomotor, psychosocial, physical and sexual. Vasomotor domain (questions 1-3), Psychosocial domain (questions 4-10), Physical space (questions 11-26), Sexual domain (questions 27-29), Each sub-domain score in the scale is ranked from 1 to 8. 1 point indicates that there is no problem with that. A score of 2 indicates that the problem exists, exists, but is not bothersome at all. Scores between 3 and 8 indicate the severity of the existing problem and its increasing degrees.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Aromatherapy Form</measure>
      <time_frame>12 week</time_frame>
      <description>The usage time and usage amount of the aromatherapy oil will be filled on the aroma therapy form for 12 weeks.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Aromatherapy</condition>
    <arm_group>
      <arm_group_label>rose oil</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>rose oil will be used</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mint oil</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>mint oil will be used</description>
    </arm_group>
    <arm_group>
      <arm_group_label>plasebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>drinking water will be used</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>placebo group</intervention_name>
      <description>aromatherapy</description>
      <arm_group_label>plasebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>mint oil group</intervention_name>
      <description>aromatherapy</description>
      <arm_group_label>mint oil</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>rose oil group</intervention_name>
      <description>aromatherapy</description>
      <arm_group_label>rose oil</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being able to speak Turkish,&#xD;
  &#xD;
            -  Getting a score above 5 in VAS&#xD;
  &#xD;
            -  Not to be allergic to the aromatherapy oils to be applied,&#xD;
  &#xD;
            -  Lack of sense of smell,&#xD;
  &#xD;
            -  Accepting to work with essential oils to be studied,&#xD;
  &#xD;
            -  Not having entered menopause naturally,&#xD;
  &#xD;
            -  Not using hormone replacement therapy,&#xD;
  &#xD;
            -  Not using complementary alternative therapy,&#xD;
  &#xD;
            -  Women who do not have a psychiatric problem,&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -Wanting to leave the study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>pre menopause&#xD;
  menopause&#xD;
  post menopause</gender_description>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Gülsen Altan, specialist nurse</last_name>
      <phone>05338597132</phone>
      <phone_ext>3666303004</phone_ext>
      <email>gulsen.altan@emu.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Gülsen Altan</last_name>
      <phone>05338597132</phone>
      <email>gulsen.altan@emu.edu.tr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Eastern Mediterranean University</name>
        <address>
          <city>Famagusta</city>
          <zip>99628</zip>
          <country>Cyprus</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Cyprus</country>
    </location_countries>
    <reference>
      <citation>Mohebitabar S, Shirazi M, Bioos S, Rahimi R, Malekshahi F, Nejatbakhsh F. Therapeutic efficacy of rose oil: A comprehensive review of clinical evidence. Avicenna J Phytomed. 2017 May-Jun;7(3):206-213.</citation>
      <PMID>28748167</PMID>
    </reference>
    <reference>
      <citation>Johnson A, Roberts L, Elkins G. Complementary and Alternative Medicine for Menopause. J Evid Based Integr Med. 2019 Jan-Dec;24:2515690X19829380. doi: 10.1177/2515690X19829380.</citation>
      <PMID>30868921</PMID>
    </reference>
    <reference>
      <citation>Short M. Menopause, mood and management. Climacteric. 2003 Aug;6 Suppl 2:33-6.</citation>
      <PMID>14669842</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Eastern Mediterranean University</investigator_affiliation>
      <investigator_full_name>Gülsen Müsteyde Altan</investigator_full_name>
      <investigator_title>lecturer</investigator_title>
    </responsible_party>
    <keyword>Aromatherapy, Vasomotor Symptoms</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06035380
  org study id: EasternMU-SBF-HB-GMAD-01
  nct id: NCT06035380
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Evaluation of the effect of aromatherapy applied to women with vasomotor complaints on
        menopausal quality of life and vasomotor symptoms.
  Menopause, ovarian failure due to loss of follicular function of the ovaries accompanied by
        estrogen deficiency, causes permanent cessation of menstruation and loss of reproductive
        function. The period in which irregularities in the menstrual cycle begin to appear and the
        chance of fertility decreases is defined as the premenopausal period. During this period,
        vasomotor complaints occur. vasomotor complaints; It is reported as hot flashes, sweating and
        night sweats . It has been reported that women experience an average of 4-5 hot flashes per
        day , and this number reaches 20 in some women . These changes are usually the most severe
        and disturbing findings two or three years before menopause and can continue in later years .
        Studies have reported that vasomotor complaints negatively affect women's quality of life.
  
        Application methods of aromatherapy with many therapeutic benefits, massage oil, face
        cream/oil, gel, body bath, hand and foot baths, compresses, hot towels, aromatic sprays, bath
        salt, inhalations (direct bottle, sniffing salt, drip on handkerchief), steam inhalation,
        facial mist, diffusion (diffuser, nebulizer, candle), ointment, mouthwash . Studies have also
        reported that aromatherapy methods used during menopause reduce vasomotor complaints and
        positively affect quality of life .
  
        Evaluating and supporting women in line with the holistic nursing approach is among the
        responsibilities of nurses. Nurses' development of appropriate care standards in line with
        these goals constitutes an important step for women to step into a healthy and high-quality
        old age. Women's health nurses should provide care, counseling and training to increase the
        quality of life of women who spend one-third of their life in the menopausal period .
  
        Studies have reported that aromatherapy has a positive effect on quality of life. However,
        studies on this subject in Türkiye and the Turkish Republic of Northern Cyprus are quite
        limited.
  
        Purpose of the research; This study will be conducted to evaluate the effect of aromatherapy
        applied to women with vasomotor complaints on menopausal quality of life and vasomotor
        symptoms.
  
        The population of the study will consist of women living in the Turkish Republic of Northern
        Cyprus, Famagusta District and reporting more than 5 vasomotor complaints according to the
        Visual Analog Scale. The sample size was determined as 66 by G*Power analysis. Three groups
        will be formed by randomization method from the people who agreed to participate in the
        study, while rose oil will be used in the first group, peppermint oil will be used in the
        second group, and the third group will form the placebo group.
  
        Essential oils to be used in groups to be treated with aromatherapy are rose and mint oils.
        In addition to the cooling effect of rose oil, it is known that thanks to its pleasant smell,
        it helps the user to feel good and is also effective in reducing menopausal symptoms. At the
        same time, peppermint oil is stated to revitalize the body, increase energy level, provide
        refreshment and reduce menopausal symptoms . It will be used after diluting by adding 10 ml
        of black cumin oil as carrier oil to 2 drops of rose and mint oils to be used in the study.
  
        In 2021, the researcher completed the 90-hour theoretical and 16-hour applied aromatherapy
        training program, coordinated by Riccon Academy-Bern-Schweiz and Adamer training center, and
        received her certificate.
  
        The placebo group will be asked to use the spray whenever they complain of hot flashes, using
        drinking water.
  
        With this randomized controlled study, it is aimed to evaluate the effect of aromatherapy
        applied to women with vasomotor complaints on menopausal quality of life and vasomotor
        symptoms, and to provide evidence for the care to be offered to menopausal women.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: randomized controlled trial
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  measure: VISUAL ANALOGUE SCALE (VAS)
  time frame: Baseline, 1 day
  description: VAS is used to convert some values that cannot be measured numerically. This scale is a safe, easily applicable test that has proven itself for a very long time and has been accepted in all the world literature. The test has no language and its ease of implementation is an important advantage. It was used in this study to determine how much hot flashes complaints experienced by women affect their lives. It was explained to the women that one end of the scale did not affect their life at all (0), and that it affected their life too much as they approached the other end (10). The women were asked to mark the number on a divided line with numbers from 0 to 10, and how much they thought their hot flashes had affected their lives.
  measure: Introductory Information Form
  time frame: Baseline, 1 day
  description: women's socio-demographic characteristics , physical characteristics , pregnancy and birth information (pregnancy). number of people living together, spousal support, menstrual pattern, last menstrual period, age of mother's menopause, chronic diseases, smoking and alcohol use, vasomotor complaints, use of CAM and nursing support are included in a total of 27 questions.
  measure: Hot Flashes Scale Specific to Menopause
  time frame: Baseline, 1 day, the ninetieth day
  description: The Menopause-Specific Hot Flashes Scale is used to measure the effect of hot flashes on overall quality of life (item 10) and nine specific activities (item 1-item 9). Nine specific activities: work, social activities, leisure activities, sleep, mood, concentration, relationships with others, sexuality, enjoyment of life. How much hot flashes affect the woman's life during the last two weeks is evaluated by numerical rating method from 0 to 10. A value of 0 means "not at all affected" and a value of 10 means "very much affected". The total score is calculated by adding the numerical values of each item.
  measure: Menopause-Specific Quality of Life Scale
  time frame: Baseline, 1 day, the ninetieth day
  description: It is a 29-item Likert-type scale. The scale consists of four domains: vasomotor, psychosocial, physical and sexual. Vasomotor domain (questions 1-3), Psychosocial domain (questions 4-10), Physical space (questions 11-26), Sexual domain (questions 27-29), Each sub-domain score in the scale is ranked from 1 to 8. 1 point indicates that there is no problem with that. A score of 2 indicates that the problem exists, exists, but is not bothersome at all. Scores between 3 and 8 indicate the severity of the existing problem and its increasing degrees.
  measure: Aromatherapy Form
  time frame: 12 week
  description: The usage time and usage amount of the aromatherapy oil will be filled on the aroma therapy form for 12 weeks.
  arm group label: rose oil
  arm group type: Experimental
  description: rose oil will be used
  arm group label: mint oil
  arm group type: Experimental
  description: mint oil will be used
  arm group label: plasebo
  arm group type: Placebo Comparator
  description: drinking water will be used
  intervention type: Other
  intervention name: placebo group
  description: aromatherapy
  arm group label: plasebo
  intervention type: Other
  intervention name: mint oil group
  description: aromatherapy
  arm group label: mint oil
  intervention type: Other
  intervention name: rose oil group
  description: aromatherapy
  arm group label: rose oil
  criteria: 
  gender: Female
  gender based: Yes
  gender description: pre menopause
  menopause
  post menopause
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gülsen Altan, specialist nurse
  phone: 05338597132
  phone ext: 3666303004
  email: gulsen.altan@emu.edu.tr
  last name: Gülsen Altan
  phone: 05338597132
  email: gulsen.altan@emu.edu.tr
  facility: 
  status: Recruiting
  country: Cyprus
  citation: Mohebitabar S, Shirazi M, Bioos S, Rahimi R, Malekshahi F, Nejatbakhsh F. Therapeutic efficacy of rose oil: A comprehensive review of clinical evidence. Avicenna J Phytomed. 2017 May-Jun;7(3):206-213.
  PMID: 28748167
  citation: Johnson A, Roberts L, Elkins G. Complementary and Alternative Medicine for Menopause. J Evid Based Integr Med. 2019 Jan-Dec;24:2515690X19829380. doi: 10.1177/2515690X19829380.
  PMID: 30868921
  citation: Short M. Menopause, mood and management. Climacteric. 2003 Aug;6 Suppl 2:33-6.
  PMID: 14669842
  responsible party type: Principal Investigator
  investigator affiliation: Eastern Mediterranean University
  investigator full name: Gülsen Müsteyde Altan
  investigator title: lecturer
  sharing ipd: No