<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/NCT04435002</url>
  </required_header>
  <id_info>
    <org_study_id>10840098-604.01.01.E.16104</org_study_id>
    <nct_id>NCT04435002</nct_id>
  </id_info>
  <brief_title>The Effect of Acupressure on Fatigue in Individuals With Chronic Fatigue Syndrome</brief_title>
  <official_title>The Effect of Acupressure on Fatigue in Individuals With Chronic Fatigue Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Medipol University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Medipol University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic fatigue syndrome is a common problem in society. The treatment of this problem is&#xD;
      limited. Acupressure is a treatment method that has become widespread and promising in recent&#xD;
      years. For this purpose, the effect of acupressure treatment on chronic fatigue syndrome was&#xD;
      investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aimed to determine the effectiveness of acupressure technique in individuals with&#xD;
      chronic symptoms. In our study, individuals participating in the study will be randomized by&#xD;
      the physiotherapist who has received the training of acupressure therapy. The study will be&#xD;
      done for a total of 10 sessions for 4 weeks. Individuals' fatigue levels will be measured by&#xD;
      Fatigue Severity Scale, their quality of life will be measured by Short Form-36 and&#xD;
      depression levels by Beck Depression Inventory. Evaluations will be made at the beginning and&#xD;
      at the end of the treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 9, 2020</start_date>
  <completion_date type="Actual">February 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 9, 2020</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>Sequential Assignment</intervention_model>
    <intervention_model_description>Randomized Controlled Clinical Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue Severity Scale</measure>
    <time_frame>5 min</time_frame>
    <description>Min Score:9 Max:63 Greater score shows greater fatigue</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory</measure>
    <time_frame>15 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form-36 questionnaire</measure>
    <time_frame>15 min</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Acupressure</condition>
  <condition>Fatigue Syndrome, Chronic</condition>
  <condition>Complementary Therapies</condition>
  <condition>Quality of Life</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For 9 different points acupressure technique applied to this group for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupressure</intervention_name>
    <description>Acupressure technics applied to (Liv- 4 , Ht-7 Bilateral, Liv-3 Bilateral, Anmian Bilateral, Yin-Tang unilateral ve Sp-6 Bilateral)</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20-45 year old&#xD;
&#xD;
          -  Not using any medical treatment,&#xD;
&#xD;
          -  Not being included in any physiotherapy program in the last 3 months,&#xD;
&#xD;
          -  Does not have any systemic disease,&#xD;
&#xD;
          -  Spending at least 4 hours at the computer or desk during the work&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fibromyalgia&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Open Wound&#xD;
&#xD;
          -  Skin Failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul Medipol University</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>August 4, 2021</last_update_submitted>
  <last_update_submitted_qc>August 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acupressure</keyword>
  <keyword>Fatigue Syndrome, Chronic,</keyword>
  <keyword>Complementary Therapies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue Syndrome, Chronic</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Not decided yet</ipd_description>
  </patient_data>
  <!-- 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/NCT04435002
org study id: 10840098-604.01.01.E.16104
nct id: NCT04435002
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Chronic fatigue syndrome is a common problem in society. The treatment of this problem is
      limited. Acupressure is a treatment method that has become widespread and promising in recent
      years. For this purpose, the effect of acupressure treatment on chronic fatigue syndrome was
      investigated.
This study aimed to determine the effectiveness of acupressure technique in individuals with
      chronic symptoms. In our study, individuals participating in the study will be randomized by
      the physiotherapist who has received the training of acupressure therapy. The study will be
      done for a total of 10 sessions for 4 weeks. Individuals' fatigue levels will be measured by
      Fatigue Severity Scale, their quality of life will be measured by Short Form-36 and
      depression levels by Beck Depression Inventory. Evaluations will be made at the beginning and
      at the end of the treatment.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Randomized Controlled Clinical Trial
primary purpose: Treatment
masking: None (Open Label)
measure: Fatigue Severity Scale
time frame: 5 min
description: Min Score:9 Max:63 Greater score shows greater fatigue
measure: Beck Depression Inventory
time frame: 15 min
measure: Short Form-36 questionnaire
time frame: 15 min
arm group label: Intervention Group
arm group type: Experimental
description: For 9 different points acupressure technique applied to this group for 4 weeks
arm group label: Control Group
arm group type: No Intervention
intervention type: Other
intervention name: Acupressure
description: Acupressure technics applied to (Liv- 4 , Ht-7 Bilateral, Liv-3 Bilateral, Anmian Bilateral, Yin-Tang unilateral ve Sp-6 Bilateral)
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Fatigue Syndrome, Chronic
mesh term: Syndrome
mesh term: Fatigue
sharing ipd: Undecided
ipd description: Not decided yet