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/NCT05970614</url>
    </required_header>
    <id_info>
      <org_study_id>OKU-SHMYO-OC-01</org_study_id>
      <nct_id>NCT05970614</nct_id>
    </id_info>
    <brief_title>The Effect of Eye Masks and Earplugs In Intensive Care Unit Patients</brief_title>
    <official_title>The Effect of Eye Masks and Earplugs on Sleep Quality and Life Findings In Intensive Care Unit Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Osmaniye Korkut Ata University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Osmaniye Korkut Ata University</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>
        This study was planned as a randomized controlled and experimental study to evaluate the&#xD;
        effect of eye masks and earplugs on sleep quality and vital signs in intensive care patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The research will be conducted with 60 patients hospitalized in the intensive care units of a&#xD;
        state hospital. Research data will be collected with a questionnaire, vital signs follow-up&#xD;
        form, insomnia severity index, and Richards-Campbell Sleep Quality Scale. Patients will be&#xD;
        divided into intervention and control groups. Eye mask and ear plugs will be applied to the&#xD;
        intervention group for 3 days, and the control group will receive routine care. The study&#xD;
        will be terminated after 3 days of follow-up for each patient.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">August 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 15, 2024</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>randomized controlled trial with control and intervention groups</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Only participants were blinded in the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Personal questionnaire</measure>
      <time_frame>Only one times. At the first meeting (up to one day).</time_frame>
      <description>It is a form consisting of 22 questions in order to investigate the sociodemographic characteristics and health status of the patients.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Vital signs follow-up form</measure>
      <time_frame>up to 3 days</time_frame>
      <description>It will be used to measure patients' fever, pulse, respiration, blood pressure and sPO2 values. It will be applied to patients at 22, 02, 06 hours. Also, the daily average hour will be calculated at the end of each day.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Insomnia Severity Index</measure>
      <time_frame>up to 3 days</time_frame>
      <description>It will be used to measure the severity of insomnia in patients. It consists of 7 questions and each question can receive points between 0 and 4. A maximum score of 28 and a minimum score of 0 are obtained on the scale, and as the score increases, the severity of insomnia increases.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Richards-Campbell Sleep Scale</measure>
      <time_frame>up to 3 days</time_frame>
      <description>The scale consists of 6 questions and the question is between 0 and 100 points. The higher the score, the higher the sleep quality.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Sleep Quality</condition>
    <condition>Vital Signs</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No application will be made to the participants. Participants will receive routine care.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>intervention group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In addition to routine care, participants will be given eye masks and ear plugs for 3 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Eye masks and ear plugs</intervention_name>
      <description>Eye masks and ear plugs will be applied to patients for 3 days between 22:00 and 06:00.</description>
      <arm_group_label>intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years and over,&#xD;
  &#xD;
            -  Able to answer all questions and communicate,&#xD;
  &#xD;
            -  Those who agreed to participate in the research&#xD;
  &#xD;
            -  Being in the category of insomnia, moderate insomnia, or severe insomnia according to&#xD;
               the insomnia severity index,&#xD;
  &#xD;
            -  Not sedating&#xD;
  &#xD;
            -  Not connected to a ventilator&#xD;
  &#xD;
            -  No hearing problem&#xD;
  &#xD;
            -  Glasgow Coma Score of 15&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Connecting to the ventilator during operation&#xD;
  &#xD;
            -  Sedation during the study&#xD;
  &#xD;
            -  Wanting to leave the research during the study&#xD;
  &#xD;
            -  Being in the intervention group and removing the eye patch or earplug during sleep&#xD;
  &#xD;
            -  GCS falling below 15&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Osmaniye Korkut Ata University</investigator_affiliation>
      <investigator_full_name>onur çetinkaya, PhD</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>sleep quality</keyword>
    <keyword>vital signs</keyword>
    <keyword>intensive care</keyword>
    <keyword>ear plugs</keyword>
    <keyword>eye masks</keyword>
    <!-- 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/NCT05970614
  org study id: OKU-SHMYO-OC-01
  nct id: NCT05970614
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study was planned as a randomized controlled and experimental study to evaluate the
        effect of eye masks and earplugs on sleep quality and vital signs in intensive care patients.
  The research will be conducted with 60 patients hospitalized in the intensive care units of a
        state hospital. Research data will be collected with a questionnaire, vital signs follow-up
        form, insomnia severity index, and Richards-Campbell Sleep Quality Scale. Patients will be
        divided into intervention and control groups. Eye mask and ear plugs will be applied to the
        intervention group for 3 days, and the control group will receive routine care. The study
        will be terminated after 3 days of follow-up for each patient.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: randomized controlled trial with control and intervention groups
  primary purpose: Supportive Care
  masking: Single (Participant)
  masking description: Only participants were blinded in the study.
  measure: Personal questionnaire
  time frame: Only one times. At the first meeting (up to one day).
  description: It is a form consisting of 22 questions in order to investigate the sociodemographic characteristics and health status of the patients.
  measure: Vital signs follow-up form
  time frame: up to 3 days
  description: It will be used to measure patients' fever, pulse, respiration, blood pressure and sPO2 values. It will be applied to patients at 22, 02, 06 hours. Also, the daily average hour will be calculated at the end of each day.
  measure: Insomnia Severity Index
  time frame: up to 3 days
  description: It will be used to measure the severity of insomnia in patients. It consists of 7 questions and each question can receive points between 0 and 4. A maximum score of 28 and a minimum score of 0 are obtained on the scale, and as the score increases, the severity of insomnia increases.
  measure: Richards-Campbell Sleep Scale
  time frame: up to 3 days
  description: The scale consists of 6 questions and the question is between 0 and 100 points. The higher the score, the higher the sleep quality.
  arm group label: Control group
  arm group type: No Intervention
  description: No application will be made to the participants. Participants will receive routine care.
  arm group label: intervention group
  arm group type: Other
  description: In addition to routine care, participants will be given eye masks and ear plugs for 3 days.
  intervention type: Other
  intervention name: Eye masks and ear plugs
  description: Eye masks and ear plugs will be applied to patients for 3 days between 22:00 and 06:00.
  arm group label: intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Osmaniye Korkut Ata University
  investigator full name: onur çetinkaya, PhD
  investigator title: Lecturer