<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/NCT04423328</url>
  </required_header>
  <id_info>
    <org_study_id>2020-03-014BC</org_study_id>
    <nct_id>NCT04423328</nct_id>
  </id_info>
  <brief_title>Establishment of Sleep Quality, Physical and Mental Health and Occupational Burnout Management Model for Shift Nursing Staff and Evaluation of Its Effectiveness</brief_title>
  <official_title>Assistant Head Nurse (Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan)</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to investigate the relationship between the personal&#xD;
      characteristics and work characteristics of shift nurses and occupational burnout, sleep&#xD;
      quality and physical and mental health. Use &quot; acupressure &quot; as an intervention to compare the&#xD;
      status of shift nurses before and after intervention and to track after interventional&#xD;
      therapy, 1, 2, and 3 months of longitudinal results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study was to investigate the relationship between the personal&#xD;
      characteristics and work characteristics of shift nurses and occupational burnout, sleep&#xD;
      quality and physical and mental health. Use &quot; acupressure &quot; as an intervention to compare the&#xD;
      status of shift nurses before and after intervention and to track after interventional&#xD;
      therapy, 1, 2, and 3 months of longitudinal results. Use the &quot;Smart Care VIP bracelet&quot; to&#xD;
      detect physical and mental conditions (psychological stress, physical fatigue) to assess the&#xD;
      applicability of the Smart Care VIP bracelet as a &quot;Shift Care Staff Sleep Quality, Physical&#xD;
      and Mental Health and Occupational Burnout Management System&quot; and evaluate effectiveness, and&#xD;
      establishment of an effective management system.&#xD;
&#xD;
      Most studies in China have shown that the use of acupressure to improve the sleep quality of&#xD;
      nursing staff generally has its efficacy, but the lack of research at proves that acupressure&#xD;
      is used by nursing staff to improve sleep quality and improve occupational burnout. It is&#xD;
      expected to be from May to December 2020. The nursing staff of a medical center in Taipei&#xD;
      will be selected for stratified sampling. The conditions for receiving the case are shift&#xD;
      nurses who have served in the institution for more than one year. Subjective sleep is&#xD;
      assessed using Epworth sleepiness scale. The objective part is to use the &quot;Smart Care VIP&#xD;
      Bracelet&quot; to measure sleep time; Chinese version of the Chinese Health Questionnaire-12&#xD;
      (CHQ-12) and occupational burnout scale questionnaire as a tool for discussion. It is planned&#xD;
      to randomly assign shift nurses to 42 acupressure groups and control group (sham), and use&#xD;
      activity record (Smart Care VIP bracelet) to monitor and record fatigue Index and stress&#xD;
      changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 28, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>sleep quality</measure>
    <time_frame>3 months</time_frame>
    <description>Epworth sleepiness scale(ESS)Epworth sleepiness Scale - Taiwan form (ESS-T):&#xD;
.The internal consistency of the scale Cronbach's α = .81, and then measured the reliability r = .74, p = .001.&#xD;
.The evaluation of the degree of drowsiness is expressed as a score of zero (never occurred) to three (almost all), with a total of 24 points.&#xD;
The higher the total score, the more severe the level of drowsiness. A zero score indicates the best situation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical and Mental Health</measure>
    <time_frame>3 months</time_frame>
    <description>Chinese Health Questionnaire-12 (CHQ-12):&#xD;
The reliability and validity of Cronbach'α was 0.83-0.92 (Cheng et al., 1990) CHQ-12 has 12 questions in total, two of which are positive. Ten questions of which are negative. It is a self-reported four-point scale. It is score from 0-0-1-1, with a total score of 12 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chinese version of the Occupational Burnout Inventory:</measure>
    <time_frame>3 months</time_frame>
    <description>The occupational burnout inventory consists of four subscales with 21 questions.&#xD;
All subscales have a score range of 0-100 points. The scale is measured by the respondent self-assessed the frequency of various problems in the past week.&#xD;
The total scale score is the sum of all subscale scores, and the higher the score, the higher the worker's feeling of burnout.&#xD;
The four subscales in the scale include personal burnout (5 questions), work burnout (5 questions), overwork (5 questions) and client burnout (6 questions).&#xD;
The Cronbach'α of the scale is above 0.84, and the scale has good construction validity and standard validity (Chang et al., 2007; Tseng, &amp; Cheng, 2002; Yeh, Cheng, Chen, &amp; Chiu, 2008).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart Rate Variability, HRV -「Smart Care VIP Bracelet Watch」</measure>
    <time_frame>3 months</time_frame>
    <description>The &quot;Smart Care VIP Bracelet Watch&quot; worn on the subject's wrist for HRV monitoring to record changes in the individual's physical activity.&#xD;
The contents of the record include the total daily sleep time (hours), waking time (minutes), number of waking, physical and mental index (mental stress, physical burnout) and other data for each case.&#xD;
To obtain the heart rate variability index directly, which represents the low frequency (LF) (%) of the sympathetic nerve activity index.&#xD;
High frequency power (HF) (%) representing the parasympathetic nerve activity index, and low frequency / high frequency power ratio (LF / HF) representing the sympathetic / parasympathetic balance index.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Sleep Quality</condition>
  <condition>Occupational Burnout</condition>
  <arm_group>
    <arm_group_label>acupressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Every day before going to sleep, massage acupoints for eight consecutive weeks, followed by Shenmen→Neiguan→Hegu acupoints.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham acupressure</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Every day before going to sleep, massage acupoints for eight consecutive weeks, followed by Waiguan→Liangqiu→Tiaokou→ Chengshan acupoints</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>acupressure</intervention_name>
    <description>self-acupressure</description>
    <arm_group_label>acupressure</arm_group_label>
    <arm_group_label>sham acupressure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Shift nursing staff who have been employed in this institution for more than one year,&#xD;
             and there have been more than two shift types in the past year. Can fill out the&#xD;
             questionnaire and agree to participate in this research and sign the consent form.&#xD;
&#xD;
          2. Chinese Health Questionnaire-12 &gt; 1.5&#xD;
&#xD;
          3. Epworth sleepiness scale &gt; 6.5 points&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Long-term (more than one month) taking sleeping pills such as Benzodiazepines,&#xD;
             Stilnox, Imovane, etc.&#xD;
&#xD;
          2. Nursing staff in the same ward as the PI.&#xD;
&#xD;
          3. Encountered major life problems one month before the intervention, such as: falling&#xD;
             out of love, family member's accident, personal diagnosis of illness, etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>63 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming-Shan Jan, master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nursing, Taipei Veterans General Hospital,</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Cheng TA, Wu JT, Chong MY, Williams P. Internal consistency and factor structure of the Chinese Health Questionnaire. Acta Psychiatr Scand. 1990 Oct;82(4):304-8. doi: 10.1111/j.1600-0447.1990.tb01389.x.</citation>
    <PMID>2260484</PMID>
  </reference>
  <reference>
    <citation>Chang, Y.J., Yeh, W.Y., Chen, C.W., Chen, C.J., Shih, T.S., &amp; Cheng, Y.W. (2007). Distribution and Correlates of Burnout among Paid Employees in Taiwan. Taiwan Journal of Public Health, 26(1), 75-87. doi:10.6288/TJPH2007-26-01-09</citation>
  </reference>
  <reference>
    <citation>Tseng, H.P., &amp; Cheng, Y.W. (2002). Reliability and Validity of the Chinese Demand-Control-Support Model and Effort-Reward Imbalance Model Questionnaires: a Study Among Employees of the Microelectronic Industry. Taiwan Journal of Public Health, 21(6), 420-432. doi:10.6288/TJPH2002-21-06-05</citation>
  </reference>
  <reference>
    <citation>Yeh, W.Y., Cheng, Y.W., Chen, M.J., &amp; Chiu, W.H. (2008). Development and validation of an occupational burnout inventory. Taiwan Journal of Public Health, 27(5), 349-364. doi: 10.6288/TJPH2008-27-05-01</citation>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sleep disturbances</keyword>
  <keyword>HRV monitoring watch</keyword>
  <keyword>health status</keyword>
  <keyword>shift rotation nurses</keyword>
  <keyword>Occupational Burnout</keyword>
  <keyword>acupressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burnout, Professional</mesh_term>
    <mesh_term>Burnout, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04423328
org study id: 2020-03-014BC
nct id: NCT04423328
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to investigate the relationship between the personal
      characteristics and work characteristics of shift nurses and occupational burnout, sleep
      quality and physical and mental health. Use " acupressure " as an intervention to compare the
      status of shift nurses before and after intervention and to track after interventional
      therapy, 1, 2, and 3 months of longitudinal results.
The purpose of this study was to investigate the relationship between the personal
      characteristics and work characteristics of shift nurses and occupational burnout, sleep
      quality and physical and mental health. Use " acupressure " as an intervention to compare the
      status of shift nurses before and after intervention and to track after interventional
      therapy, 1, 2, and 3 months of longitudinal results. Use the "Smart Care VIP bracelet" to
      detect physical and mental conditions (psychological stress, physical fatigue) to assess the
      applicability of the Smart Care VIP bracelet as a "Shift Care Staff Sleep Quality, Physical
      and Mental Health and Occupational Burnout Management System" and evaluate effectiveness, and
      establishment of an effective management system.

      Most studies in China have shown that the use of acupressure to improve the sleep quality of
      nursing staff generally has its efficacy, but the lack of research at proves that acupressure
      is used by nursing staff to improve sleep quality and improve occupational burnout. It is
      expected to be from May to December 2020. The nursing staff of a medical center in Taipei
      will be selected for stratified sampling. The conditions for receiving the case are shift
      nurses who have served in the institution for more than one year. Subjective sleep is
      assessed using Epworth sleepiness scale. The objective part is to use the "Smart Care VIP
      Bracelet" to measure sleep time; Chinese version of the Chinese Health Questionnaire-12
      (CHQ-12) and occupational burnout scale questionnaire as a tool for discussion. It is planned
      to randomly assign shift nurses to 42 acupressure groups and control group (sham), and use
      activity record (Smart Care VIP bracelet) to monitor and record fatigue Index and stress
      changes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: sleep quality
time frame: 3 months
description: Epworth sleepiness scale(ESS)Epworth sleepiness Scale - Taiwan form (ESS-T):
.The internal consistency of the scale Cronbach's α = .81, and then measured the reliability r = .74, p = .001.
.The evaluation of the degree of drowsiness is expressed as a score of zero (never occurred) to three (almost all), with a total of 24 points.
The higher the total score, the more severe the level of drowsiness. A zero score indicates the best situation.
measure: Physical and Mental Health
time frame: 3 months
description: Chinese Health Questionnaire-12 (CHQ-12):
The reliability and validity of Cronbach'α was 0.83-0.92 (Cheng et al., 1990) CHQ-12 has 12 questions in total, two of which are positive. Ten questions of which are negative. It is a self-reported four-point scale. It is score from 0-0-1-1, with a total score of 12 points.
measure: Chinese version of the Occupational Burnout Inventory:
time frame: 3 months
description: The occupational burnout inventory consists of four subscales with 21 questions.
All subscales have a score range of 0-100 points. The scale is measured by the respondent self-assessed the frequency of various problems in the past week.
The total scale score is the sum of all subscale scores, and the higher the score, the higher the worker's feeling of burnout.
The four subscales in the scale include personal burnout (5 questions), work burnout (5 questions), overwork (5 questions) and client burnout (6 questions).
The Cronbach'α of the scale is above 0.84, and the scale has good construction validity and standard validity (Chang et al., 2007; Tseng, & Cheng, 2002; Yeh, Cheng, Chen, & Chiu, 2008).
measure: Heart Rate Variability, HRV -「Smart Care VIP Bracelet Watch」
time frame: 3 months
description: The "Smart Care VIP Bracelet Watch" worn on the subject's wrist for HRV monitoring to record changes in the individual's physical activity.
The contents of the record include the total daily sleep time (hours), waking time (minutes), number of waking, physical and mental index (mental stress, physical burnout) and other data for each case.
To obtain the heart rate variability index directly, which represents the low frequency (LF) (%) of the sympathetic nerve activity index.
High frequency power (HF) (%) representing the parasympathetic nerve activity index, and low frequency / high frequency power ratio (LF / HF) representing the sympathetic / parasympathetic balance index.
arm group label: acupressure
arm group type: Experimental
description: Every day before going to sleep, massage acupoints for eight consecutive weeks, followed by Shenmen→Neiguan→Hegu acupoints.
arm group label: sham acupressure
arm group type: Sham Comparator
description: Every day before going to sleep, massage acupoints for eight consecutive weeks, followed by Waiguan→Liangqiu→Tiaokou→ Chengshan acupoints
intervention type: Behavioral
intervention name: acupressure
description: self-acupressure
arm group label: acupressure
arm group label: sham acupressure
criteria: 
gender: All
minimum age: 22 Years
maximum age: 63 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ming-Shan Jan, master
role: Principal Investigator
affiliation: Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan
facility: 
country: Taiwan
citation: Cheng TA, Wu JT, Chong MY, Williams P. Internal consistency and factor structure of the Chinese Health Questionnaire. Acta Psychiatr Scand. 1990 Oct;82(4):304-8. doi: 10.1111/j.1600-0447.1990.tb01389.x.
PMID: 2260484
citation: Chang, Y.J., Yeh, W.Y., Chen, C.W., Chen, C.J., Shih, T.S., & Cheng, Y.W. (2007). Distribution and Correlates of Burnout among Paid Employees in Taiwan. Taiwan Journal of Public Health, 26(1), 75-87. doi:10.6288/TJPH2007-26-01-09
citation: Tseng, H.P., & Cheng, Y.W. (2002). Reliability and Validity of the Chinese Demand-Control-Support Model and Effort-Reward Imbalance Model Questionnaires: a Study Among Employees of the Microelectronic Industry. Taiwan Journal of Public Health, 21(6), 420-432. doi:10.6288/TJPH2002-21-06-05
citation: Yeh, W.Y., Cheng, Y.W., Chen, M.J., & Chiu, W.H. (2008). Development and validation of an occupational burnout inventory. Taiwan Journal of Public Health, 27(5), 349-364. doi: 10.6288/TJPH2008-27-05-01
responsible party type: Sponsor
mesh term: Burnout, Professional
mesh term: Burnout, Psychological
sharing ipd: No