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/NCT05983497</url>
    </required_header>
    <id_info>
      <org_study_id>MRC-01-22-581</org_study_id>
      <nct_id>NCT05983497</nct_id>
    </id_info>
    <brief_title>Effect of Self-care Skill Education on the Compassionate Satisfaction and Compassionate Fatigue Among Clinical Nurses Clinical Nurses at HMC</brief_title>
    <official_title>Effect of Self-care Skill Educational Intervention on the Compassionate Satisfaction and Compassionate Fatigue Among Clinical Nurses at HMC: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hamad Medical Corporation</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hamad Medical Corporation</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 health of our nurses is perhaps the most important consideration for delivering excellent&#xD;
        patient care. The passionate approach of nurses can lead to a lot of fatigue and stress among&#xD;
        nurses. Their health is perhaps the most important consideration for delivering excellent&#xD;
        patient care. Self-care provides nurses with the framework for managing professional burnout,&#xD;
        compassion fatigue, and traumatic stress. The aim of this study is to assess the impact of&#xD;
        self-care skill educational intervention on increasing compassion satisfaction and reducing&#xD;
        compassionate fatigue among clinical nurses. The interactive Self-care skill education will&#xD;
        be administrated and evaluated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Within the healthcare industry, healthcare professionals particularly nurses, are exposed to&#xD;
        emotionally challenging and stressful situations, further, they experience increased levels&#xD;
        of burnout and stress secondary to the nature of their work and work environment. The ability&#xD;
        to manage work-related stress and burnout is vital to patient care and the individual health&#xD;
        of nursing staff.&#xD;
  &#xD;
        After the extensive literature search, it was identified that a dearth of studies was&#xD;
        conducted in Qatar that explored the prevalence of burnout among different healthcare&#xD;
        professionals. Most the of studies evaluated risk predictor and prevalence rate whereas no&#xD;
        intervention studies to reduce the rates was found in Qatar. Organizational support through&#xD;
        workplace intervention and the mitigating plan for the mental well-being of nurses is of&#xD;
        utmost importance and has proven to be of merit. The researcher is interested to bring down&#xD;
        the trend of the prevalence rate of compassionate fatigue through cost-effective self-care&#xD;
        skill educational intervention among clinical nurses and to increase their compassionate&#xD;
        satisfaction which in turn impacts nurses' work satisfaction and quality of care for&#xD;
        patients.&#xD;
  &#xD;
        The study aims to assess the effect of the self-care skill educational intervention on&#xD;
        increasing compassion satisfaction among Nurses. This study uses a prospective, parallel&#xD;
        group, randomized control group design to compare those who received Self -care Educational&#xD;
        intervention to no intervention among clinical nurses. The samples will be divided into two&#xD;
        groups and subjects will be randomly assigned to both groups. The research team will simple&#xD;
        randomization method for randomly assigning the subjects to both arms.&#xD;
  &#xD;
        A total of 224 samples are needed for the study. The samples will be randomly assigned to the&#xD;
        two arms. The Professional Quality of Life Tool will be used for compassion fatigue and&#xD;
        compassion satisfaction level among clinical nurses. This tool is considered valid and&#xD;
        reliable. Assessment using ProQOL will be done at the beginning of administering the&#xD;
        intervention and after 4 weeks of post-intervention.&#xD;
  &#xD;
        An evidence-based interactive self-care skill educational intervention is developed by the&#xD;
        research team and validated. The intervention will be delivered as 1-day activity-based&#xD;
        educational training. The self-care skill educational intervention consist following content:&#xD;
        the concept of compassion fatigue, burnout awareness and recognition, eight dimensions of&#xD;
        well-being, concept of self-care and followed by a demonstration of 7 guided self-care skill&#xD;
        activities sleep hygiene, self-talk, gratitude Practices, Journaling, breathing exercise,&#xD;
        heartfulness relaxation, and heartfulness meditation. At the end of the educational&#xD;
        intervention, Participants will receive an instructional leaflet to practice the 7 self-care&#xD;
        skills that they gained from the educational activity. The participants are encouraged to&#xD;
        practice based on the developed self-care plan.&#xD;
  &#xD;
        The participants from the Control group will not receive any kind of intervention. after the&#xD;
        4 weeks assessed using ProQOL tool.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 20, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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 uses a prospective, parallel group, randomized control group design to compare those received self-care skill educational intervention and the control group (no kind of intervention) among clinical nurses.&#xD;
  The samples will be divided into experimental and control groups by randomly assigning the subjects to each group.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Due to the nature of the study educational intervention, the subjects and investigators are not masked. However, the outcome assessors are marked for analysis.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Increase in the Compassion Satisfaction</measure>
      <time_frame>4 weeks</time_frame>
      <description>The primary outcome will enhance the increase in compassionate satisfaction as assessed by using the ProQOL-5. The ProQOL tool is a standardized tool to assess compassion satisfaction and compassion fatigue which are valid and reliable.&#xD;
  The ProQOL examines compassion satisfaction, burnout, and secondary traumatic stress. The 5-point Likert scale (1=Never to 5=Very often) is divided into 3 subscales of 30 items and 10 items measuring each concept. the Compassion satisfaction subscales range from 10- 50, the Higher score more than 23 indicates increase Compassion Satisfaction.&#xD;
  The researcher is expecting an increase in compassion satisfaction levels among clinical nurses from the self-care skill educational intervention group as compared with non intervention group</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Self-care</condition>
    <condition>Compassion Satisfaction</condition>
    <condition>Compassion Fatigue</condition>
    <condition>Educational Intervention</condition>
    <arm_group>
      <arm_group_label>Experimental: Self-care skill Education</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A total of 112 Participants will be assigned to the experimental group. Self-care skill educational intervention is administered to all the participants.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No Intervention:</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>A total of 112 Participants will be assigned to the control group.No intervention will be received</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Self-Care Skill Educational Intervention</intervention_name>
      <description>An evidence-based interactive self-care skill educational intervention that supports the clinical nurses to reduce compassion fatigue and increase the compassion satisfaction. The intervention will be delivered as 1-day activity-based educational training. The educational activity consists of the following content: the concept of compassionate fatigue, burnout awareness and recognition, eight dimensions of well-being, and followed by a demonstration of 7 guided self-care skill activities *on practicing sleep hygiene, self-talk, gratitude practice, Journaling, breathing exercise, heartfulness relaxation, and heartfulness meditation. After the activity participants will develop their own self-care plan for practicing the self-care skills. At the end of the session, they will receive the instructional leaflet to practice the 7 self care skills that they gained from the educational activity.</description>
      <arm_group_label>Experimental: Self-care skill Education</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Licensed registered Clinical nurses working all inpatient areas&#xD;
  &#xD;
            -  The nurses who are involved in direct patient care.&#xD;
  &#xD;
            -  Anticipated availability for the complete program.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  New staff who are under preceptorship period.&#xD;
  &#xD;
            -  Clinical Nurses working in the outpatient department&#xD;
  &#xD;
            -  Staff who are not willing to participate&#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_contact>
      <last_name>Surekha Kiran Patil, Masters</last_name>
      <phone>55404109</phone>
      <phone_ext>+974</phone_ext>
      <email>spatil@hamad.qa</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dr. Badriya Al-Lenjawi, PhD</last_name>
      <phone>55559584</phone>
      <phone_ext>+974</phone_ext>
      <email>Blenjawi@hamad.qa</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hamad Medical Corporation</name>
        <address>
          <city>Doha</city>
          <zip>5040</zip>
          <country>Qatar</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Surekha Kiran Patil, Masters</last_name>
        <phone>55404109</phone>
        <phone_ext>+974</phone_ext>
        <email>spatil@hamad.qa</email>
      </contact>
      <contact_backup>
        <last_name>Dr. Badriya Lenjawi, PhD</last_name>
        <phone>55559584</phone>
        <email>Blenjawi@hamad.qa</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Qatar</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hamad Medical Corporation</investigator_affiliation>
      <investigator_full_name>Surekha Kiran Patil</investigator_full_name>
      <investigator_title>Nurse Educator -II, Nursing and Midwifery Education Department, HMC, Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fatigue</mesh_term>
      <mesh_term>Compassion Fatigue</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>All the data will be stored in a database by the principal investigator. Only PI will have access to the data base with a password. The Data will be shared only with the concerned research team member. The collected study data and analysis will be stored in the password-protected computer of the PI in NMED, HMC. The hard copies of the consent will be stored in a locker of P.I in NMED, HMC.&#xD;
  Subject identifiers will not be shared outside HMC.</ipd_description>
    </patient_data>
    <!-- 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/NCT05983497
  org study id: MRC-01-22-581
  nct id: NCT05983497
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The health of our nurses is perhaps the most important consideration for delivering excellent
        patient care. The passionate approach of nurses can lead to a lot of fatigue and stress among
        nurses. Their health is perhaps the most important consideration for delivering excellent
        patient care. Self-care provides nurses with the framework for managing professional burnout,
        compassion fatigue, and traumatic stress. The aim of this study is to assess the impact of
        self-care skill educational intervention on increasing compassion satisfaction and reducing
        compassionate fatigue among clinical nurses. The interactive Self-care skill education will
        be administrated and evaluated.
  Within the healthcare industry, healthcare professionals particularly nurses, are exposed to
        emotionally challenging and stressful situations, further, they experience increased levels
        of burnout and stress secondary to the nature of their work and work environment. The ability
        to manage work-related stress and burnout is vital to patient care and the individual health
        of nursing staff.
  
        After the extensive literature search, it was identified that a dearth of studies was
        conducted in Qatar that explored the prevalence of burnout among different healthcare
        professionals. Most the of studies evaluated risk predictor and prevalence rate whereas no
        intervention studies to reduce the rates was found in Qatar. Organizational support through
        workplace intervention and the mitigating plan for the mental well-being of nurses is of
        utmost importance and has proven to be of merit. The researcher is interested to bring down
        the trend of the prevalence rate of compassionate fatigue through cost-effective self-care
        skill educational intervention among clinical nurses and to increase their compassionate
        satisfaction which in turn impacts nurses' work satisfaction and quality of care for
        patients.
  
        The study aims to assess the effect of the self-care skill educational intervention on
        increasing compassion satisfaction among Nurses. This study uses a prospective, parallel
        group, randomized control group design to compare those who received Self -care Educational
        intervention to no intervention among clinical nurses. The samples will be divided into two
        groups and subjects will be randomly assigned to both groups. The research team will simple
        randomization method for randomly assigning the subjects to both arms.
  
        A total of 224 samples are needed for the study. The samples will be randomly assigned to the
        two arms. The Professional Quality of Life Tool will be used for compassion fatigue and
        compassion satisfaction level among clinical nurses. This tool is considered valid and
        reliable. Assessment using ProQOL will be done at the beginning of administering the
        intervention and after 4 weeks of post-intervention.
  
        An evidence-based interactive self-care skill educational intervention is developed by the
        research team and validated. The intervention will be delivered as 1-day activity-based
        educational training. The self-care skill educational intervention consist following content:
        the concept of compassion fatigue, burnout awareness and recognition, eight dimensions of
        well-being, concept of self-care and followed by a demonstration of 7 guided self-care skill
        activities sleep hygiene, self-talk, gratitude Practices, Journaling, breathing exercise,
        heartfulness relaxation, and heartfulness meditation. At the end of the educational
        intervention, Participants will receive an instructional leaflet to practice the 7 self-care
        skills that they gained from the educational activity. The participants are encouraged to
        practice based on the developed self-care plan.
  
        The participants from the Control group will not receive any kind of intervention. after the
        4 weeks assessed using ProQOL tool.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study uses a prospective, parallel group, randomized control group design to compare those received self-care skill educational intervention and the control group (no kind of intervention) among clinical nurses.
  The samples will be divided into experimental and control groups by randomly assigning the subjects to each group.
  primary purpose: Health Services Research
  masking: Single (Outcomes Assessor)
  masking description: Due to the nature of the study educational intervention, the subjects and investigators are not masked. However, the outcome assessors are marked for analysis.
  measure: Increase in the Compassion Satisfaction
  time frame: 4 weeks
  description: The primary outcome will enhance the increase in compassionate satisfaction as assessed by using the ProQOL-5. The ProQOL tool is a standardized tool to assess compassion satisfaction and compassion fatigue which are valid and reliable.
  The ProQOL examines compassion satisfaction, burnout, and secondary traumatic stress. The 5-point Likert scale (1=Never to 5=Very often) is divided into 3 subscales of 30 items and 10 items measuring each concept. the Compassion satisfaction subscales range from 10- 50, the Higher score more than 23 indicates increase Compassion Satisfaction.
  The researcher is expecting an increase in compassion satisfaction levels among clinical nurses from the self-care skill educational intervention group as compared with non intervention group
  arm group label: Experimental: Self-care skill Education
  arm group type: Experimental
  description: A total of 112 Participants will be assigned to the experimental group. Self-care skill educational intervention is administered to all the participants.
  arm group label: No Intervention:
  arm group type: No Intervention
  description: A total of 112 Participants will be assigned to the control group.No intervention will be received
  intervention type: Other
  intervention name: Self-Care Skill Educational Intervention
  description: An evidence-based interactive self-care skill educational intervention that supports the clinical nurses to reduce compassion fatigue and increase the compassion satisfaction. The intervention will be delivered as 1-day activity-based educational training. The educational activity consists of the following content: the concept of compassionate fatigue, burnout awareness and recognition, eight dimensions of well-being, and followed by a demonstration of 7 guided self-care skill activities *on practicing sleep hygiene, self-talk, gratitude practice, Journaling, breathing exercise, heartfulness relaxation, and heartfulness meditation. After the activity participants will develop their own self-care plan for practicing the self-care skills. At the end of the session, they will receive the instructional leaflet to practice the 7 self care skills that they gained from the educational activity.
  arm group label: Experimental: Self-care skill Education
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Surekha Kiran Patil, Masters
  phone: 55404109
  phone ext: +974
  email: spatil@hamad.qa
  last name: Dr. Badriya Al-Lenjawi, PhD
  phone: 55559584
  phone ext: +974
  email: Blenjawi@hamad.qa
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Qatar
  responsible party type: Principal Investigator
  investigator affiliation: Hamad Medical Corporation
  investigator full name: Surekha Kiran Patil
  investigator title: Nurse Educator -II, Nursing and Midwifery Education Department, HMC, Principal Investigator
  mesh term: Fatigue
  mesh term: Compassion Fatigue
  sharing ipd: No
  ipd description: All the data will be stored in a database by the principal investigator. Only PI will have access to the data base with a password. The Data will be shared only with the concerned research team member. The collected study data and analysis will be stored in the password-protected computer of the PI in NMED, HMC. The hard copies of the consent will be stored in a locker of P.I in NMED, HMC.
  Subject identifiers will not be shared outside HMC.