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/NCT06028685</url>
    </required_header>
    <id_info>
      <org_study_id>2022-06-002B</org_study_id>
      <nct_id>NCT06028685</nct_id>
    </id_info>
    <brief_title>Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis</brief_title>
    <official_title>Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Taipei Veterans General Hospital, Taiwan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Taipei Veterans General Hospital, Taiwan</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>
        Hemodialysis is a necessary treatment to prolong the lives of patients with end-stage kidney&#xD;
        disease. However, long-term dialysis can lead to fatigue and decreased sleep quality.&#xD;
        Acupoint stimulation can regulate meridians and improve physical function. Nevertheless, the&#xD;
        effectiveness of low-level laser stimulation on fatigue and sleep quality in hemodialysis&#xD;
        patients remains unclear.&#xD;
  &#xD;
        This study is designed to use low-level laser stimulation as an intervention measure to&#xD;
        evaluate its effectiveness in improving fatigue and sleep quality in hemodialysis patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hemodialysis is a necessary treatment to prolong the lives of patients with end-stage kidney&#xD;
        disease. However, long-term dialysis can lead to fatigue and decreased sleep quality.&#xD;
        Acupoint stimulation can regulate meridians and improve physical function. Nevertheless, the&#xD;
        effectiveness of low-level laser stimulation on fatigue and sleep quality in hemodialysis&#xD;
        patients remains unclear.&#xD;
  &#xD;
        This study is designed to use low-level laser stimulation as an intervention measure to&#xD;
        evaluate its effectiveness in improving fatigue and sleep quality in hemodialysis patients.&#xD;
  &#xD;
        The experimental group will receive low-level laser stimulation on seven acupoints, including&#xD;
        Shenmen (HT7), Neiguan (PC6), Hegu (LI4), Zusanli (ST36), Yanglingquan (GB34), Sanyinjiao&#xD;
        (SP6), and Taixi (KI3). The stimulation will be administered three times per week for a&#xD;
        duration of six weeks. The control group will receive sham low-level laser stimulation on the&#xD;
        acupoints, without emitting laser beams.&#xD;
  &#xD;
        Before and after each intervention, fatigue will be measured using a visual analog scale for&#xD;
        a total of 18 measurements. Additionally, at baseline and at the 2nd, 4th, and 6th weeks, the&#xD;
        hemodialysis patients will be assessed using the Fatigue Scale for Hemodialysis Patients,&#xD;
        Dialysis Recovery Time Scale, Pittsburgh Sleep Quality Index, Dialysis Symptom Index, and&#xD;
        Beck Depression Inventory.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 12, 2022</start_date>
    <completion_date type="Actual">February 21, 2023</completion_date>
    <primary_completion_date type="Actual">December 20, 2022</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>This study adopts an experimental research design.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>This study employs computer-based random allocation, where the assignments are sealed in opaque envelopes. The researchers open the envelopes to distribute participants into the experimental and control groups, ensuring blinding of the study participants. The data analysts responsible for statistical analysis are separate individuals who are unaware of the participants' grouping.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>fatigue1</measure>
      <time_frame>Three times per week, for six weeks, totaling 18 sessions.</time_frame>
      <description>The fatigue visual analogue scale：The score ranges from 0 to 10 points, with higher scores indicating a higher level of fatigue.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>fatigue2</measure>
      <time_frame>measured at baseline and at the 2nd, 4th, and 6th weeks.</time_frame>
      <description>Fatigue Scale for Hemodialysis Patients：The score ranges from 26 to 104 points, with higher scores indicating a higher level of fatigue.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>fatigue3</measure>
      <time_frame>measured at baseline and at the 2nd, 4th, and 6th weeks.</time_frame>
      <description>Dialysis recovery time: The recovery time is divided into four intervals, including less than 2 hours, 2-6 hours, 7-12 hours, and greater than 12 hours. This is determined by responses from dialysis patients regarding the time needed for recovery during dialysis treatment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>sleep</measure>
      <time_frame>measured at baseline and at the 2nd, 4th, and 6th weeks.</time_frame>
      <description>Pittsburgh Sleep Quality Index：The total score ranges from 0 to 21 points, with higher scores indicating poorer sleep quality.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">72</enrollment>
    <condition>Hemodialysis</condition>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The experimental group will receive low-level laser stimulation on seven acupoints. The stimulation will be administered three times per week for a duration of six weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The control group will receive sham low-level laser stimulation on the acupoints, without emitting laser beams.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Acupoint stimulation</intervention_name>
      <description>The experimental group will receive low-level laser stimulation on seven acupoints, including Shenmen (HT7), Neiguan (PC6), Hegu (LI4), Zusanli (ST36), Yanglingquan (GB34), Sanyinjiao (SP6), and Taixi (KI3). The stimulation will be administered three times per week for a duration of six weeks.</description>
      <arm_group_label>experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Acupoint stimulation(placebo)</intervention_name>
      <description>The control group will receive sham low-level laser stimulation on seven acupoints, including Shenmen (HT7), Neiguan (PC6), Hegu (LI4), Zusanli (ST36), Yanglingquan (GB34), Sanyinjiao (SP6), and Taixi (KI3), without emitting laser beams.The stimulation will be administered three times per week for a duration of six weeks.</description>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adults aged 20 years and above.&#xD;
  &#xD;
            2. Diagnosed with end-stage kidney disease and receiving regular outpatient hemodialysis&#xD;
               three times a week for at least three months.&#xD;
  &#xD;
            3. Conscious and capable of communication in Mandarin or Taiwanese (Hokkien).&#xD;
  &#xD;
            4. Willing to participate in this study and have signed the informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Presence of skin lesions or infectious wounds at the acupoint locations.&#xD;
  &#xD;
            2. Taking immunosuppressive medication.&#xD;
  &#xD;
            3. Photosensitivity or sensitivity to light.&#xD;
  &#xD;
            4. Individuals with implanted cardiac pacemakers.&#xD;
  &#xD;
            5. Patients using sleep medication.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rou-Yu Sung</last_name>
      <role>Principal Investigator</role>
      <affiliation>Taipei Veterans General Hospital, Taiwan</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Taipei Veterans General Hospital</name>
        <address>
          <city>Taipei</city>
          <zip>11217</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>fatigue</keyword>
    <keyword>sleep</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>
  
  
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/NCT06028685
  org study id: 2022-06-002B
  nct id: NCT06028685
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Hemodialysis is a necessary treatment to prolong the lives of patients with end-stage kidney
        disease. However, long-term dialysis can lead to fatigue and decreased sleep quality.
        Acupoint stimulation can regulate meridians and improve physical function. Nevertheless, the
        effectiveness of low-level laser stimulation on fatigue and sleep quality in hemodialysis
        patients remains unclear.
  
        This study is designed to use low-level laser stimulation as an intervention measure to
        evaluate its effectiveness in improving fatigue and sleep quality in hemodialysis patients.
  Hemodialysis is a necessary treatment to prolong the lives of patients with end-stage kidney
        disease. However, long-term dialysis can lead to fatigue and decreased sleep quality.
        Acupoint stimulation can regulate meridians and improve physical function. Nevertheless, the
        effectiveness of low-level laser stimulation on fatigue and sleep quality in hemodialysis
        patients remains unclear.
  
        This study is designed to use low-level laser stimulation as an intervention measure to
        evaluate its effectiveness in improving fatigue and sleep quality in hemodialysis patients.
  
        The experimental group will receive low-level laser stimulation on seven acupoints, including
        Shenmen (HT7), Neiguan (PC6), Hegu (LI4), Zusanli (ST36), Yanglingquan (GB34), Sanyinjiao
        (SP6), and Taixi (KI3). The stimulation will be administered three times per week for a
        duration of six weeks. The control group will receive sham low-level laser stimulation on the
        acupoints, without emitting laser beams.
  
        Before and after each intervention, fatigue will be measured using a visual analog scale for
        a total of 18 measurements. Additionally, at baseline and at the 2nd, 4th, and 6th weeks, the
        hemodialysis patients will be assessed using the Fatigue Scale for Hemodialysis Patients,
        Dialysis Recovery Time Scale, Pittsburgh Sleep Quality Index, Dialysis Symptom Index, and
        Beck Depression Inventory.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study adopts an experimental research design.
  primary purpose: Supportive Care
  masking: Double (Participant, Outcomes Assessor)
  masking description: This study employs computer-based random allocation, where the assignments are sealed in opaque envelopes. The researchers open the envelopes to distribute participants into the experimental and control groups, ensuring blinding of the study participants. The data analysts responsible for statistical analysis are separate individuals who are unaware of the participants' grouping.
  measure: fatigue1
  time frame: Three times per week, for six weeks, totaling 18 sessions.
  description: The fatigue visual analogue scale：The score ranges from 0 to 10 points, with higher scores indicating a higher level of fatigue.
  measure: fatigue2
  time frame: measured at baseline and at the 2nd, 4th, and 6th weeks.
  description: Fatigue Scale for Hemodialysis Patients：The score ranges from 26 to 104 points, with higher scores indicating a higher level of fatigue.
  measure: fatigue3
  time frame: measured at baseline and at the 2nd, 4th, and 6th weeks.
  description: Dialysis recovery time: The recovery time is divided into four intervals, including less than 2 hours, 2-6 hours, 7-12 hours, and greater than 12 hours. This is determined by responses from dialysis patients regarding the time needed for recovery during dialysis treatment.
  measure: sleep
  time frame: measured at baseline and at the 2nd, 4th, and 6th weeks.
  description: Pittsburgh Sleep Quality Index：The total score ranges from 0 to 21 points, with higher scores indicating poorer sleep quality.
  arm group label: experimental group
  arm group type: Active Comparator
  description: The experimental group will receive low-level laser stimulation on seven acupoints. The stimulation will be administered three times per week for a duration of six weeks.
  arm group label: control group
  arm group type: Placebo Comparator
  description: The control group will receive sham low-level laser stimulation on the acupoints, without emitting laser beams.
  intervention type: Device
  intervention name: Acupoint stimulation
  description: The experimental group will receive low-level laser stimulation on seven acupoints, including Shenmen (HT7), Neiguan (PC6), Hegu (LI4), Zusanli (ST36), Yanglingquan (GB34), Sanyinjiao (SP6), and Taixi (KI3). The stimulation will be administered three times per week for a duration of six weeks.
  arm group label: experimental group
  intervention type: Device
  intervention name: Acupoint stimulation(placebo)
  description: The control group will receive sham low-level laser stimulation on seven acupoints, including Shenmen (HT7), Neiguan (PC6), Hegu (LI4), Zusanli (ST36), Yanglingquan (GB34), Sanyinjiao (SP6), and Taixi (KI3), without emitting laser beams.The stimulation will be administered three times per week for a duration of six weeks.
  arm group label: control group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Rou-Yu Sung
  role: Principal Investigator
  affiliation: Taipei Veterans General Hospital, Taiwan
  facility: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Fatigue