<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/NCT03251274</url>
  </required_header>
  <id_info>
    <org_study_id>CMUH105-REC3-138</org_study_id>
    <nct_id>NCT03251274</nct_id>
  </id_info>
  <brief_title>Bath Machine on Sleep Quality in Nursing Home</brief_title>
  <official_title>The Effect of Eddy Current Function of Bath Machine on Sleep Quality in Nursing Home</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University Hospital</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>
      The study is divided into two stages, the purposes of the first stage are (1) to examine the&#xD;
      feasibility and simplicity of the operation of bathtub machine for nurse aides; (2) to&#xD;
      examine the safety and comfortability of the bathtub machine from the perspectives of the&#xD;
      nurse aides. The purposes of the second stage are (1) to understand the experiences of nurse&#xD;
      aides and the elderly with disability by using the bathtub machine(which has edde massage&#xD;
      function); (2) to evaluate the effectiveness of using the bathtub machine on the sleep&#xD;
      quality and body temperature in the elderly with disability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trends of bath disability in elderly consistently increased and, enhance, the demand of&#xD;
      helping bath for the elderly also increased in Taiwan. Bathing is an important item of&#xD;
      activities of daily living for human. Bathing not only keeps the body clean but also makes&#xD;
      body comfort. Some studies showed that taking hot (40-40.5°C) baths 1.5 - 2 hours before&#xD;
      bedtime resulted in a significant increase slow wave sleep (SWS) in the early part of the&#xD;
      sleep period and improving sleep continuity in older female insomniacs.&#xD;
&#xD;
      Nurse aides are one of important human resource for long-term care institution. In Taiwan,&#xD;
      Chao et al. reported that nurse aides had long-term accumulating discomfort over neck,&#xD;
      shoulders and lower back during helping disable residents to carry out activity daily life.&#xD;
      However, the body discomfort in nurse aides significantly decreased by using auxiliary&#xD;
      equipment during assisting the elderly to carry out activity daily life. Therefore, it is&#xD;
      important to use auxiliary equipment to prevent injury during work for nurse aides.&#xD;
&#xD;
      This study is interested in applying edde massage bathtub to improve sleep quality for&#xD;
      disable residents in long-term care institutions. The study is divided into two stages, first&#xD;
      stage of the study is to train nurse aides to use the bathtub machine (which has edde massage&#xD;
      function) and solicits the opinions of nurse aides about factors related to the accessibility&#xD;
      and safety of bath-tub machine using focus group methods. The purposes of the first stage&#xD;
      study are (1) to examine the feasibility and simplicity of the operation of bathtub machine&#xD;
      for nurse aides; (2) to examine the safety and comfortability of the bathtub machine from the&#xD;
      perspectives of the nurse aides.&#xD;
&#xD;
      Second stage of the study is to explore the experiences of nurse aides and disabled elderly&#xD;
      by using the bathtub machine. The purposes of the second stage study are (1) to understand&#xD;
      the experiences of nurse aides and the elderly with disability by using the bathtub&#xD;
      machine(which has edde massage function); (2) to evaluate the effectiveness of using the&#xD;
      bathtub machine on the sleep quality and body temperature in the elderly with disability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">September 5, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>machine bathing group traditional bathing group</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>sleep quality</measure>
    <time_frame>the night after intervention</time_frame>
    <description>Polysomnography, PSG</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>machine bathing group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>structured machine bathing for 20-min duration at evening.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>traditional bathing group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>traditional bathing at evening.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>machine bathing</intervention_name>
    <description>machine bathing 20-min duration at evening</description>
    <arm_group_label>machine bathing group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>traditional bathing</intervention_name>
    <description>traditional bathing</description>
    <arm_group_label>traditional bathing group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  More than half a year in the institution&#xD;
&#xD;
          -  18 years of age (including) or above, with the help of bathing&#xD;
&#xD;
          -  Be conscious, able to listen, speak Chinese&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute illness&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Peripheral blood vessels or neurological diseases&#xD;
&#xD;
          -  Mental disorders&#xD;
&#xD;
          -  Sleep apnea&#xD;
&#xD;
          -  Long-term hemodialysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chung-Liang Lai</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taichung Hospital, Ministry of Health and Welfare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taichung Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40343</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>March 5, 2020</last_update_submitted>
  <last_update_submitted_qc>March 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bath machine</keyword>
  <keyword>sleep quality</keyword>
  <keyword>nursing home</keyword>
  <keyword>heart rate variability</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>participant's data of polysomnography and heart rate variability can be shared</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/NCT03251274
org study id: CMUH105-REC3-138
nct id: NCT03251274
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is divided into two stages, the purposes of the first stage are (1) to examine the
      feasibility and simplicity of the operation of bathtub machine for nurse aides; (2) to
      examine the safety and comfortability of the bathtub machine from the perspectives of the
      nurse aides. The purposes of the second stage are (1) to understand the experiences of nurse
      aides and the elderly with disability by using the bathtub machine(which has edde massage
      function); (2) to evaluate the effectiveness of using the bathtub machine on the sleep
      quality and body temperature in the elderly with disability.
The trends of bath disability in elderly consistently increased and, enhance, the demand of
      helping bath for the elderly also increased in Taiwan. Bathing is an important item of
      activities of daily living for human. Bathing not only keeps the body clean but also makes
      body comfort. Some studies showed that taking hot (40-40.5°C) baths 1.5 - 2 hours before
      bedtime resulted in a significant increase slow wave sleep (SWS) in the early part of the
      sleep period and improving sleep continuity in older female insomniacs.

      Nurse aides are one of important human resource for long-term care institution. In Taiwan,
      Chao et al. reported that nurse aides had long-term accumulating discomfort over neck,
      shoulders and lower back during helping disable residents to carry out activity daily life.
      However, the body discomfort in nurse aides significantly decreased by using auxiliary
      equipment during assisting the elderly to carry out activity daily life. Therefore, it is
      important to use auxiliary equipment to prevent injury during work for nurse aides.

      This study is interested in applying edde massage bathtub to improve sleep quality for
      disable residents in long-term care institutions. The study is divided into two stages, first
      stage of the study is to train nurse aides to use the bathtub machine (which has edde massage
      function) and solicits the opinions of nurse aides about factors related to the accessibility
      and safety of bath-tub machine using focus group methods. The purposes of the first stage
      study are (1) to examine the feasibility and simplicity of the operation of bathtub machine
      for nurse aides; (2) to examine the safety and comfortability of the bathtub machine from the
      perspectives of the nurse aides.

      Second stage of the study is to explore the experiences of nurse aides and disabled elderly
      by using the bathtub machine. The purposes of the second stage study are (1) to understand
      the experiences of nurse aides and the elderly with disability by using the bathtub
      machine(which has edde massage function); (2) to evaluate the effectiveness of using the
      bathtub machine on the sleep quality and body temperature in the elderly with disability.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: machine bathing group traditional bathing group
primary purpose: Health Services Research
masking: None (Open Label)
measure: sleep quality
time frame: the night after intervention
description: Polysomnography, PSG
arm group label: machine bathing group
arm group type: Experimental
description: structured machine bathing for 20-min duration at evening.
arm group label: traditional bathing group
arm group type: Active Comparator
description: traditional bathing at evening.
intervention type: Other
intervention name: machine bathing
description: machine bathing 20-min duration at evening
arm group label: machine bathing group
intervention type: Other
intervention name: traditional bathing
description: traditional bathing
arm group label: traditional bathing group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chung-Liang Lai
role: Principal Investigator
affiliation: Taichung Hospital, Ministry of Health and Welfare
facility: 
country: Taiwan
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: participant's data of polysomnography and heart rate variability can be shared