<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/NCT04467645</url>
  </required_header>
  <id_info>
    <org_study_id>LZA2018/4</org_study_id>
    <nct_id>NCT04467645</nct_id>
  </id_info>
  <brief_title>The Effect of Reflexology on Sleep Quality and Fatigue in Postmenopausal Women</brief_title>
  <official_title>The Effect of Reflexology on Sleep Quality and Fatigue in Postmenopausal Women: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dicle University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dicle 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>
      Introduction: This study was conducted to determine the effect of reflexology on sleep&#xD;
      quality and fatigue in postmenopausal women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was conducted in Batıkent Family Health Center of the Ministry of Health between&#xD;
      May-December 2018. The sample of the study consisted of 72 postmenopausal women. The data&#xD;
      were collected by using the Introductory Information Form, Pittsburgh Sleep Quality Index and&#xD;
      Fatigue Severity Scale. A total of 12 reflexology sessions were applied to the postmenopausal&#xD;
      women by the researcher twice a week. No intervention was applied to the postmenopausal women&#xD;
      in the control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">September 28, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</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>Crossover Assignment</intervention_model>
    <intervention_model_description>This study was conducted as a pretest-posttest trial model with a control group in order to determine the effect of reflexology applications on sleep quality and fatigue in postmenopausal women</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reflexology Application, Pre-tests applied Pittsburgh Sleep Quality Index (PSQI), and Fatigue Severity Scale (FSS).</measure>
    <time_frame>first week</time_frame>
    <description>A PSQI score of 5 or higher indicates poor sleep quality. A mean total score on the FSS of four and above indicates chronic fatigue.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Healthy</condition>
  <condition>Nursing Caries</condition>
  <arm_group>
    <arm_group_label>Reflexology</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reflexology Application: A total of twelve 30-minute reflexology sessions (2 per week)were administered to each patient.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention was applied to the postmenopausal women in the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>reflexology</intervention_name>
    <description>Reflexology is the stimulation of the reflex points in the hands and feet by massage, designed to provide relaxation and relief in the body.</description>
    <arm_group_label>Reflexology</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  able to communicate,&#xD;
&#xD;
          -  aged 50 to 65,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  taking hormone replacement therapy,&#xD;
&#xD;
          -  chronic diseases (such as diabetes, hypertension, and so on),&#xD;
&#xD;
          -  psychiatric disease,&#xD;
&#xD;
          -  diagnosed with a sleep disorder attributed to other cause&#xD;
&#xD;
          -  menstruation for more than one year&#xD;
&#xD;
          -  history of alcohol or drug addiction&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leyla ZENGİN AYDIN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dicle University, Diyarbakır, Turkey. 21100/Diyarbakır</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Leyla ZENGİN AYDIN</name>
      <address>
        <city>Diyarbakır</city>
        <state>Sur</state>
        <zip>21280</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dicle University</investigator_affiliation>
    <investigator_full_name>Leyla ZENGİN AYDIN</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Nurse</keyword>
  <keyword>postmenopausal women</keyword>
  <keyword>sleep</keyword>
  <keyword>reflexology</keyword>
  <keyword>fatigue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04467645
org study id: LZA2018/4
nct id: NCT04467645
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction: This study was conducted to determine the effect of reflexology on sleep
      quality and fatigue in postmenopausal women.
This study was conducted in Batıkent Family Health Center of the Ministry of Health between
      May-December 2018. The sample of the study consisted of 72 postmenopausal women. The data
      were collected by using the Introductory Information Form, Pittsburgh Sleep Quality Index and
      Fatigue Severity Scale. A total of 12 reflexology sessions were applied to the postmenopausal
      women by the researcher twice a week. No intervention was applied to the postmenopausal women
      in the control group.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This study was conducted as a pretest-posttest trial model with a control group in order to determine the effect of reflexology applications on sleep quality and fatigue in postmenopausal women
primary purpose: Supportive Care
masking: Single (Care Provider)
measure: Reflexology Application, Pre-tests applied Pittsburgh Sleep Quality Index (PSQI), and Fatigue Severity Scale (FSS).
time frame: first week
description: A PSQI score of 5 or higher indicates poor sleep quality. A mean total score on the FSS of four and above indicates chronic fatigue.
arm group label: Reflexology
arm group type: Experimental
description: Reflexology Application: A total of twelve 30-minute reflexology sessions (2 per week)were administered to each patient.
arm group label: No intervention
arm group type: No Intervention
description: No intervention was applied to the postmenopausal women in the control group.
intervention type: Other
intervention name: reflexology
description: Reflexology is the stimulation of the reflex points in the hands and feet by massage, designed to provide relaxation and relief in the body.
arm group label: Reflexology
criteria: 
gender: Female
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Leyla ZENGİN AYDIN
role: Principal Investigator
affiliation: Dicle University, Diyarbakır, Turkey. 21100/Diyarbakır
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Dicle University
investigator full name: Leyla ZENGİN AYDIN
investigator title: Assistant Professor
mesh term: Fatigue