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/NCT06016491</url>
    </required_header>
    <id_info>
      <org_study_id>Mersin Univers</org_study_id>
      <nct_id>NCT06016491</nct_id>
    </id_info>
    <brief_title>The Effect of Acupressure on Menopausal Symptoms</brief_title>
    <official_title>The Effect of Acupressure on Menopausal Symptoms: A Randomized, Sham Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mersin University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mersin 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>
        This is a prospective, randomized, placebo-controlled and single-blind study planned to&#xD;
        determine the effect of acupressure application on menopausal symptoms.&#xD;
  &#xD;
        The hypothesis of the study is that acupressure reduces women's menopausal symptoms.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Menopause is a physiological process during which most women have difficulties and face many&#xD;
        problems. Acupressure can be taught and used safely as an effective method to manage the&#xD;
        symptoms that women experience during menopause.&#xD;
  &#xD;
        This study aims to determine the effect of acupressure on menopausal symptoms. The study has&#xD;
        a prospective, randomized, sham-controlled, single-blind design. The research was conducted&#xD;
        with 81 women (acupressure n=40, sham acupressure n=41) attending the &quot;Menopause School&quot; in a&#xD;
        public hospital in Türkiye between July 05, 2021 and August 02, 2021. Both groups received&#xD;
        acupressure application thrice a week for four weeks, 12 sessions in total. The data was&#xD;
        obtained using a personal information form and a Menopause Rating Scale.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 5, 2021</start_date>
    <completion_date type="Actual">March 21, 2022</completion_date>
    <primary_completion_date type="Actual">August 2, 2021</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>81 people who attended the menopause school and met the inclusion criteria were selected by simple random sampling. Each of the women was allowed to draw from the numbers in the bell, and those who drew odd numbers were assigned to the placebo group, and those who drew even numbers were assigned to the acupressure group. Acupressure pressure point was applied to all women included in the study. Participants were blinded because they did not know whether the women were given acupressure or placebo acupressure. Researchers could not be blinded because they were also practitioners (Melek Yeşil Bayülgen and Fatma Hikmet Yeşil). When the research was completed, the data were analyzed by a statistician who did not know the groups and the findings were reported</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Menopause Rating Scale (MRS)</measure>
      <time_frame>Change from before implementation, 0th week and 4th week of practice</time_frame>
      <description>Menopause symptom rating scale was used to evaluate menopausal symptoms. The Turkish reliability and validity study was conducted by Can (2005). The scale consists of 11 items and 3 sub-dimensions. For each item, there are &quot;0=None&quot;, &quot;1=Mild&quot;, &quot;2=Moderate&quot;, &quot;3=Severe&quot; and &quot;4=Very Severe&quot; options. Sub-dimensions of the scale; somatic complaints (items 1,2,3 and 11), psychological complaints (items 4,5,6 and 7), and urogenital complaints (items 8,9 and 10). The total score of the scale ranges from 0 to 44. The somatic complaints sub-dimension is scored between 0-16, the psychological complaints sub-dimension 0-16, and the urogenital complaints sub-dimension 0-12. An increase in the total score obtained from the scale indicates that the severity of the complaints increases and the quality of life is negatively affected.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">81</enrollment>
    <condition>Menopause</condition>
    <condition>Acupressure</condition>
    <arm_group>
      <arm_group_label>Acupressure group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Before the acupressure application, the woman to be applied was informed in a quiet room for ease of application, and then she was ensured to be in a comfortable position. Women were taught to practice on a total of two points, the kidney meridian (Yong Quan-KD1) and the spleen meridian (Sanyinjiao-SP6). Since the symmetry of the selected two different points on the other extremity will also be applied, a total of 8 minutes of compression was applied to each point, provided that it was two minutes. Depending on the preparation and compression time on each point, an average of 10 minutes was applied to each patient, and then the patients were asked to apply it to themselves. After making sure that the women learned, they were asked to apply acupressure on their own. They applied a total of 12 sessions, three times a week for a total of four weeks. To remind the session day, information was given by the researcher via short message.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham acupressure group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>After all the preparations (suitability of sound and environment and information) before the application to the acupressure group were made in the sham group, the sham acupressure points determined parallel to the KD1 and SP6 points (approximately 1-1.5 cm away) were put on the bone area where the meridians do not pass has been applied.&#xD;
  Similar to the acupressure group, the sham acupresuure group was treated with symmetrical extremities and for similar durations.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>acupressure</intervention_name>
      <description>Depending on the preparation and compression time on each point, an average of 10 minutes was applied to each woman, and then the person were asked to apply it to themselves. After making sure that the women learned, they were asked to apply acupressure on their own. They applied a total of 12 sessions, three times a week for a total of four weeks.</description>
      <arm_group_label>Acupressure group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Sham acupressure</intervention_name>
      <description>Compression was applied on the bone region where the meridians did not pass, parallel to the KD1 and SP6 points (approximately 1-1.5 cm away). Similar to the acupressure group, the sham group was treated with symmetrical extremities and for similar durati</description>
      <arm_group_label>Sham acupressure group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Able to speak and understand Turkish&#xD;
  &#xD;
            -  No psychiatric illness&#xD;
  &#xD;
            -  Natural menopause&#xD;
  &#xD;
            -  Not on hormone replacement therapy&#xD;
  &#xD;
            -  Women who volunteered to participate in the study and did not receive any integrated&#xD;
               therapy were included.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who have undergone menopause with the surgical method&#xD;
  &#xD;
            -  For lower extremity vascular disease, fracture, sprain or injury, diabetes,&#xD;
               cardiovascular disease, thyroid disease, etc. with a diagnosis&#xD;
  &#xD;
            -  Women who received any integrative therapy were not included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Mersin University</name>
        <address>
          <city>Mersin</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mersin University</investigator_affiliation>
      <investigator_full_name>Melek Yesil Bayulgen</investigator_full_name>
      <investigator_title>Lecturer (Principal Investigator)</investigator_title>
    </responsible_party>
    <keyword>Menopause</keyword>
    <keyword>Acupressure</keyword>
    <keyword>Menopausal 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/NCT06016491
  org study id: Mersin Univers
  nct id: NCT06016491
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective, randomized, placebo-controlled and single-blind study planned to
        determine the effect of acupressure application on menopausal symptoms.
  
        The hypothesis of the study is that acupressure reduces women's menopausal symptoms.
  Menopause is a physiological process during which most women have difficulties and face many
        problems. Acupressure can be taught and used safely as an effective method to manage the
        symptoms that women experience during menopause.
  
        This study aims to determine the effect of acupressure on menopausal symptoms. The study has
        a prospective, randomized, sham-controlled, single-blind design. The research was conducted
        with 81 women (acupressure n=40, sham acupressure n=41) attending the "Menopause School" in a
        public hospital in Türkiye between July 05, 2021 and August 02, 2021. Both groups received
        acupressure application thrice a week for four weeks, 12 sessions in total. The data was
        obtained using a personal information form and a Menopause Rating Scale.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  masking description: 81 people who attended the menopause school and met the inclusion criteria were selected by simple random sampling. Each of the women was allowed to draw from the numbers in the bell, and those who drew odd numbers were assigned to the placebo group, and those who drew even numbers were assigned to the acupressure group. Acupressure pressure point was applied to all women included in the study. Participants were blinded because they did not know whether the women were given acupressure or placebo acupressure. Researchers could not be blinded because they were also practitioners (Melek Yeşil Bayülgen and Fatma Hikmet Yeşil). When the research was completed, the data were analyzed by a statistician who did not know the groups and the findings were reported
  measure: Menopause Rating Scale (MRS)
  time frame: Change from before implementation, 0th week and 4th week of practice
  description: Menopause symptom rating scale was used to evaluate menopausal symptoms. The Turkish reliability and validity study was conducted by Can (2005). The scale consists of 11 items and 3 sub-dimensions. For each item, there are "0=None", "1=Mild", "2=Moderate", "3=Severe" and "4=Very Severe" options. Sub-dimensions of the scale; somatic complaints (items 1,2,3 and 11), psychological complaints (items 4,5,6 and 7), and urogenital complaints (items 8,9 and 10). The total score of the scale ranges from 0 to 44. The somatic complaints sub-dimension is scored between 0-16, the psychological complaints sub-dimension 0-16, and the urogenital complaints sub-dimension 0-12. An increase in the total score obtained from the scale indicates that the severity of the complaints increases and the quality of life is negatively affected.
  arm group label: Acupressure group
  arm group type: Experimental
  description: Before the acupressure application, the woman to be applied was informed in a quiet room for ease of application, and then she was ensured to be in a comfortable position. Women were taught to practice on a total of two points, the kidney meridian (Yong Quan-KD1) and the spleen meridian (Sanyinjiao-SP6). Since the symmetry of the selected two different points on the other extremity will also be applied, a total of 8 minutes of compression was applied to each point, provided that it was two minutes. Depending on the preparation and compression time on each point, an average of 10 minutes was applied to each patient, and then the patients were asked to apply it to themselves. After making sure that the women learned, they were asked to apply acupressure on their own. They applied a total of 12 sessions, three times a week for a total of four weeks. To remind the session day, information was given by the researcher via short message.
  arm group label: Sham acupressure group
  arm group type: Sham Comparator
  description: After all the preparations (suitability of sound and environment and information) before the application to the acupressure group were made in the sham group, the sham acupressure points determined parallel to the KD1 and SP6 points (approximately 1-1.5 cm away) were put on the bone area where the meridians do not pass has been applied.
  Similar to the acupressure group, the sham acupresuure group was treated with symmetrical extremities and for similar durations.
  intervention type: Behavioral
  intervention name: acupressure
  description: Depending on the preparation and compression time on each point, an average of 10 minutes was applied to each woman, and then the person were asked to apply it to themselves. After making sure that the women learned, they were asked to apply acupressure on their own. They applied a total of 12 sessions, three times a week for a total of four weeks.
  arm group label: Acupressure group
  intervention type: Behavioral
  intervention name: Sham acupressure
  description: Compression was applied on the bone region where the meridians did not pass, parallel to the KD1 and SP6 points (approximately 1-1.5 cm away). Similar to the acupressure group, the sham group was treated with symmetrical extremities and for similar durati
  arm group label: Sham acupressure group
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Mersin University
  investigator full name: Melek Yesil Bayulgen
  investigator title: Lecturer (Principal Investigator)
  sharing ipd: No