<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/NCT02228161</url>
  </required_header>
  <id_info>
    <org_study_id>101107</org_study_id>
    <nct_id>NCT02228161</nct_id>
  </id_info>
  <brief_title>The Effects of Yoga in Mental Health Professional Helpers</brief_title>
  <official_title>The Effects of Yoga on Work-related Stress and Stress Adaption Among the Professional Helpers of Psychiatry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Bing Show Chwan Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Bing Show Chwan Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate if yoga exercises decrease work-related stress and improve stress&#xD;
      adaptation in professional health helpers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mental health professional helpers including psychiatrists, nurses, psychologists, social&#xD;
      workers and occupational therapists often call upon to maintain a good working attitude and&#xD;
      enthusiasm, especially in the face of the evaluators of credential systems as well as&#xD;
      supervisors' authorities. The symptoms of work-related stress of professional helpers&#xD;
      developed day by days and affected their physical and mental health. Gradually, the&#xD;
      professional helpers burned out. Philip Burnard (1991) mentioned professional helpers might&#xD;
      self-neglect while helping others. These would lead to over work related stress that directly&#xD;
      affects the physical and mental health of the professional helpers, and indirectly affects&#xD;
      the organization to take care of the patients and their families.&#xD;
&#xD;
      According to researchers and personal experience, colleagues of mental health care developed&#xD;
      work-related stress symptoms, such as insomnia or sleep disorder, the physiological&#xD;
      disorders, weight fluctuations, irritable or depressed while taking care of psychiatric&#xD;
      patients. They might take tranquilizers in order to maintain the quality of work. On the&#xD;
      other hand, in April 2012, the researchers engaged in yoga teaching, assisting mental health&#xD;
      care to help others of engaging in yoga practice showed that members perceived positive&#xD;
      feelings after the yoga practice: &quot;the mood is more relaxed,&quot; &quot;tight body become more relaxed&#xD;
      and soft resulting in awareness of tension and unease. This helps to modify long-term adverse&#xD;
      stances and reduce body aches and/or sitting.&quot; For this reason, researchers began to apply&#xD;
      yoga to the release work-related stress and enhance stress adaptation. Professional health&#xD;
      helpers look forward to practice yoga exercises to relax work-related stress and improve&#xD;
      stress adaptation.&#xD;
&#xD;
      It is a parallel-arm randomized control trial compare the outcome of participants assign to&#xD;
      the experimental treatment group (yoga, with 30 participants) with those assign to a control&#xD;
      group for 3 months (12 weeks). Experimental group receive regular 60-minutes yoga classes&#xD;
      twice a week. We confer the difference of work-related stress relief and stress adaptation&#xD;
      and biofeedback improvement after yoga.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2013</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease work-related stress and improve stress adaptation.</measure>
    <time_frame>3 months intervention</time_frame>
    <description>Work-related stress and stress adaptation will be assessed by questionnaires including personality, work-related stress and stress adaption scale and biofeedback index using heart rate variability at two different times: (1)baseline data: before yoga program ,(2)outcome data:3 months yoga exercise, right after exercise measures post-test.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Occupation-related Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Yoga exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participatants will receive regular 60-minutes yoga classes twice a week for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regular schedule of daily living</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will maintain regular schedule as usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga</intervention_name>
    <description>Yoga group will receive regular 60-minutes yoga classes twice a week for 3 months.</description>
    <arm_group_label>Yoga exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mental Health Professional Helpers.&#xD;
&#xD;
          -  Without sport training.&#xD;
&#xD;
          -  Age 20~60.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Musculoskeletal injury.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shu-Hui Yeh Yeh, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Show Chwan Memorial Hospital &amp; Central Taiwan University of Science and Technology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shu-Ling Lin, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Bing Show Chwan Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shu-Hui Yeh, PhD</last_name>
    <email>yehshuhui@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kuender D Yang, PhD</last_name>
    <phone>886-975617006</phone>
    <email>yangkd.yeh@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital</name>
      <address>
        <city>Changhua County</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shu-Hui Yeh</last_name>
      <email>yehshuhui@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>September 2, 2014</last_update_submitted>
  <last_update_submitted_qc>September 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Bing Show Chwan Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Shu-Hui Yeh</investigator_full_name>
    <investigator_title>RN, PhD, Professor</investigator_title>
  </responsible_party>
  <keyword>Yoga</keyword>
  <keyword>Work-related Stress,</keyword>
  <keyword>Stress Adaptation.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Occupational Stress</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</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/NCT02228161
org study id: 101107
nct id: NCT02228161
lead sponsor: 
has dmc: No
This study will investigate if yoga exercises decrease work-related stress and improve stress
      adaptation in professional health helpers.
Mental health professional helpers including psychiatrists, nurses, psychologists, social
      workers and occupational therapists often call upon to maintain a good working attitude and
      enthusiasm, especially in the face of the evaluators of credential systems as well as
      supervisors' authorities. The symptoms of work-related stress of professional helpers
      developed day by days and affected their physical and mental health. Gradually, the
      professional helpers burned out. Philip Burnard (1991) mentioned professional helpers might
      self-neglect while helping others. These would lead to over work related stress that directly
      affects the physical and mental health of the professional helpers, and indirectly affects
      the organization to take care of the patients and their families.

      According to researchers and personal experience, colleagues of mental health care developed
      work-related stress symptoms, such as insomnia or sleep disorder, the physiological
      disorders, weight fluctuations, irritable or depressed while taking care of psychiatric
      patients. They might take tranquilizers in order to maintain the quality of work. On the
      other hand, in April 2012, the researchers engaged in yoga teaching, assisting mental health
      care to help others of engaging in yoga practice showed that members perceived positive
      feelings after the yoga practice: "the mood is more relaxed," "tight body become more relaxed
      and soft resulting in awareness of tension and unease. This helps to modify long-term adverse
      stances and reduce body aches and/or sitting." For this reason, researchers began to apply
      yoga to the release work-related stress and enhance stress adaptation. Professional health
      helpers look forward to practice yoga exercises to relax work-related stress and improve
      stress adaptation.

      It is a parallel-arm randomized control trial compare the outcome of participants assign to
      the experimental treatment group (yoga, with 30 participants) with those assign to a control
      group for 3 months (12 weeks). Experimental group receive regular 60-minutes yoga classes
      twice a week. We confer the difference of work-related stress relief and stress adaptation
      and biofeedback improvement after yoga.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Decrease work-related stress and improve stress adaptation.
time frame: 3 months intervention
description: Work-related stress and stress adaptation will be assessed by questionnaires including personality, work-related stress and stress adaption scale and biofeedback index using heart rate variability at two different times: (1)baseline data: before yoga program ,(2)outcome data:3 months yoga exercise, right after exercise measures post-test.
arm group label: Yoga exercise
arm group type: Experimental
description: Participatants will receive regular 60-minutes yoga classes twice a week for 3 months.
arm group label: Regular schedule of daily living
arm group type: No Intervention
description: Participants will maintain regular schedule as usual.
intervention type: Behavioral
intervention name: Yoga
description: Yoga group will receive regular 60-minutes yoga classes twice a week for 3 months.
arm group label: Yoga exercise
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shu-Hui Yeh Yeh, PhD
role: Study Director
affiliation: Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
last name: Shu-Ling Lin, MS
role: Principal Investigator
affiliation: Chang Bing Show Chwan Memorial Hospital
last name: Shu-Hui Yeh, PhD
email: yehshuhui@gmail.com
last name: Kuender D Yang, PhD
phone: 886-975617006
email: yangkd.yeh@hotmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Bing Show Chwan Memorial Hospital
investigator full name: Shu-Hui Yeh
investigator title: RN, PhD, Professor
mesh term: Occupational Stress
mesh term: Stress Disorders, Traumatic