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/NCT05993988</url>
    </required_header>
    <id_info>
      <org_study_id>Karatayanxiety</org_study_id>
      <nct_id>NCT05993988</nct_id>
    </id_info>
    <brief_title>The Effect of Telerehabilitation on Clinical Stress Level and Stress Responses in Nursing Students</brief_title>
    <official_title>The Effect of Telerehabilitation Practice on the Clinical Stress Level and Stress Responses of Nursing Students During Their First Clinical Experience</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>KTO Karatay University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>KTO Karatay University</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>
        It was aimed to examine the effect of telerehabilitation on clinical stress level and stress&#xD;
        responses in nursing students.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It was aimed to examine the effect of telerehabilitation on clinical stress level and stress&#xD;
        responses in nursing students.There is no study in the literature examining the relationship&#xD;
        between telerehabilitation and clinical stress in nursing students. Since our study will be&#xD;
        the first to investigate the subject, we foresee that it is scientifically important and will&#xD;
        shed light on future studies. In addition, national or international publications are planned&#xD;
        after the study is completed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Actual">June 1, 2023</completion_date>
    <primary_completion_date type="Actual">May 1, 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>parallel assignment</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>single</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Perceived Stress Scale for Nursing Students</measure>
      <time_frame>baseline and 4 weeks</time_frame>
      <description>Sheu et al. (2002) originally in Chinese, the scale consists of 29 items.Total score; It ranges from 0 to 116. A high score indicates a high level of stress. The internal consistency coefficient value of the original scale is 0.86.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Biopsychosocial Response Scale of Nursing Students</measure>
      <time_frame>baseline and 4 weeks</time_frame>
      <description>The scale was developed by Sheu et al. (2002). There are 21 items in the scale.Total score; It ranges from 0 to 84 (sub-dimension total scores are 32, 28, and 24 points, respectively). High score indicates more symptom presence and poor bio-psycho-social status.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">75</enrollment>
    <condition>Stress</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The participants in the control group did not receive any intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Exercise group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participants in the exercise group performed Jacobson muscle relaxation exercises with a specialist physiotherapist through the Zoom program (https://zoom.us). The exercises were applied 4 days a week for 4 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercise</intervention_name>
      <description>Muscle relaxing Technique</description>
      <arm_group_label>Exercise group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  to be between the ages of 18-24&#xD;
  &#xD;
            -  to do the first clinical internship in the hospital&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  have joint limitation&#xD;
  &#xD;
            -  have congenital anomaly&#xD;
  &#xD;
            -  have any orthopedic problem&#xD;
  &#xD;
            -  have any serious psychological problems&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>24 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Mustafa Savaş Torlak</name>
        <address>
          <city>Karatay</city>
          <state>Eyalet/Yerleşke</state>
          <zip>42000</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>KTO Karatay University</investigator_affiliation>
      <investigator_full_name>Mustafa Savaş Torlak</investigator_full_name>
      <investigator_title>Ass. Prof.</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT05993988
  org study id: Karatayanxiety
  nct id: NCT05993988
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  It was aimed to examine the effect of telerehabilitation on clinical stress level and stress
        responses in nursing students.
  It was aimed to examine the effect of telerehabilitation on clinical stress level and stress
        responses in nursing students.There is no study in the literature examining the relationship
        between telerehabilitation and clinical stress in nursing students. Since our study will be
        the first to investigate the subject, we foresee that it is scientifically important and will
        shed light on future studies. In addition, national or international publications are planned
        after the study is completed.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: parallel assignment
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: single
  measure: Perceived Stress Scale for Nursing Students
  time frame: baseline and 4 weeks
  description: Sheu et al. (2002) originally in Chinese, the scale consists of 29 items.Total score; It ranges from 0 to 116. A high score indicates a high level of stress. The internal consistency coefficient value of the original scale is 0.86.
  measure: Biopsychosocial Response Scale of Nursing Students
  time frame: baseline and 4 weeks
  description: The scale was developed by Sheu et al. (2002). There are 21 items in the scale.Total score; It ranges from 0 to 84 (sub-dimension total scores are 32, 28, and 24 points, respectively). High score indicates more symptom presence and poor bio-psycho-social status.
  arm group label: control group
  arm group type: No Intervention
  description: The participants in the control group did not receive any intervention.
  arm group label: Exercise group
  arm group type: Experimental
  description: The participants in the exercise group performed Jacobson muscle relaxation exercises with a specialist physiotherapist through the Zoom program (https://zoom.us). The exercises were applied 4 days a week for 4 weeks.
  intervention type: Other
  intervention name: Exercise
  description: Muscle relaxing Technique
  arm group label: Exercise group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 24 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: KTO Karatay University
  investigator full name: Mustafa Savaş Torlak
  investigator title: Ass. Prof.
  sharing ipd: Undecided