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/NCT06025136</url>
    </required_header>
    <id_info>
      <org_study_id>2022-PO198</org_study_id>
      <nct_id>NCT06025136</nct_id>
    </id_info>
    <brief_title>The Effect of the Use of Gel Pillows on the Sleep Quality and General Comfort Levels</brief_title>
    <official_title>The Effect of the Use of Gel Pillows on the Sleep Quality and General Comfort Levels of the Patients in the Preoperative Period</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Trakya University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Trakya University</source>
    <oversight_info>
      <has_dmc>Yes</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 study was conducted to evaluate the effect of using gel pillows on the sleep quality and&#xD;
        general comfort levels of patients in the preoperative period.The main hypotheses are:&#xD;
  &#xD;
        H1: 'The sleep quality of patients who use gel pillows in the preoperative period is higher&#xD;
        than those who do not use gel pillows' H2: &quot;The general comfort level of the patients who&#xD;
        used gel pillows in the preoperative period is higher than those who did not use gel&#xD;
        pillows&quot;.&#xD;
  &#xD;
        Participants will be asked to use a gel pillow with a cooling surface the night before the&#xD;
        day of surgery.&#xD;
  &#xD;
        If there is a comparison group: Researchers will compare patients' control group to see if&#xD;
        there is any difference in sleep quality and comfort levels.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Randomization method will be used to determine the groups. Randomization of the patients was&#xD;
        done using the 'Random Allocation Software 2.0' program and they are allocated into 2 groups:&#xD;
        1) the control group and 2) the intervenion group.&#xD;
  &#xD;
          1. The Control Group: The patients in this group will be visited by the researcher in their&#xD;
             rooms on the morning before the surgery. Patients will be informed that they will be&#xD;
             visited again in the evening of the day before the surgery and that they will be given a&#xD;
             pillow to use while sleeping at night. They will receive no other interventions.Patients&#xD;
             will be visited again on the morning of the surgery day.The Richard Campbell Sleep Scale&#xD;
             was used to evaluate the nighttime sleep quality of the patients;General Comfort Scale&#xD;
             to evaluate comfort levels.&#xD;
  &#xD;
          2. The Intervenion Group: The patients in this group will be visited by the researcher in&#xD;
             their rooms on the morning before the surgery. Patients will be informed that they will&#xD;
             be visited again in the evening of the day before the surgery and that they will be&#xD;
             given a pillow to use while sleeping at night. Patients who are visited in their rooms&#xD;
             on the evening of the day before the surgery will be given a gel pillow with a cooling&#xD;
             surface feature for night use. If patients stop using pillows at night, they will be&#xD;
             asked to inform the investigator when they come to their room in the morning.Patients&#xD;
             will be visited again on the morning of the surgery day.The Richard Campbell Sleep Scale&#xD;
             was used to evaluate the nighttime sleep quality of the patients;General Comfort Scale&#xD;
             to evaluate comfort levels.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 8, 2022</start_date>
    <completion_date type="Anticipated">September 22, 2023</completion_date>
    <primary_completion_date type="Actual">August 8, 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>The research will be conducted using randomized controlled, experimental type and single-blind research methods. For this purpose, after the data are collected, they will be coded as A and B groups, so the researcher who will make the research statistics will analyze the data without knowing the study and control groups. Randomization method will be used to determine the groups. For this, the patients who meet the study criteria and volunteer will be assigned to the groups using the randomization program 'Random Allocation Software 2.0' according to the order of hospitalization.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The data analyse is going to be completed by a independent researcher.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Sleep quality level</measure>
      <time_frame>12 mounth</time_frame>
      <description>Sleep quality of the patietns will be evaluated with Richards Campbell Sleep Scale. Each item in the scale is evaluated on a chart between 0 and 100 using the visual analog scale technique. The total score of the scale is evaluated over 5 items, and the 6th item, which evaluates the noise level in the environment, is excluded from the total score evaluation. A score of &quot;0-25&quot; from the scale indicates very bad sleep, and a score of &quot;76-100&quot; indicates very good sleep. The high score of the scale indicates that the sleep quality of the patients is high.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Comfort level</measure>
      <time_frame>12 mounth</time_frame>
      <description>Comfort level of the patietns will be evalueated with General Comfort Scale. The lowest total score that can be obtained from the scale is 48, and the highest total score is 192. The average value is determined by dividing the total score obtained by the number of scale items, and the result is indicated in the 1-4 distribution. Low comfort is expressed by one point, high comfort by four points.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Preoperative</condition>
    <condition>Sleep</condition>
    <condition>Comfort</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients who are visited in their rooms on the evening of the day before the surgery will be given a gel pillow with a cooling surface feature for night use. Patients will be asked to note the time they go to bed for a night's sleep and the time they wake up on the morning of the surgery. If patients stop using pillows at night, they will be asked to inform the investigator when they come to their room in the morning.Patients will be visited again on the morning of the surgery day.The Richard Campbell Sleep Scale was used to evaluate the nighttime sleep quality of the patients;General Comfort Scale to evaluate comfort.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The patients who were visited in their rooms on the evening of the day before the operation will be given pillows that have the same characteristics as the pillows that the patients in the study group will use, but do not have a gel surface, to use at night. Patients will be asked to note the time they go to bed for a night's sleep and the time they wake up on the morning of the surgery.Participants in the control group will receive no other interventions.Patients will be visited again on the morning of the surgery day.The Richard Campbell Sleep Scale was used to evaluate the nighttime sleep quality of the patients;General Comfort Scale to evaluate comfort levels.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Using a gel pillow</intervention_name>
      <description>Within the scope of the study, gel pillows with a cold surface were used in the patients in the study group. It is produced by combining the obtained special liquid with elastic material with NASA approved molecule exchange technology and is made of OEKO-TEX CLASS 1 certified material.Thanks to the gel material on the pillow surface, the surface temperature is reduced from 37°C to 24°C in about 10 seconds. It gives a feeling of coolness with its thermal conductivity feature.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          To research;&#xD;
  &#xD;
            -  Planned elective surgery&#xD;
  &#xD;
            -  Those who will undergo cancer surgery related to the gastrointestinal system&#xD;
  &#xD;
            -  No diagnosis of sleep disorder&#xD;
  &#xD;
            -  No sensory, cognitive or mental disability&#xD;
  &#xD;
            -  Using pillows while sleeping&#xD;
  &#xD;
            -  Patients who volunteered to participate in the study were included.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Emergency surgical intervention will be performed&#xD;
  &#xD;
            -  In contact isolation&#xD;
  &#xD;
            -  The one who has given up using a gel pillow for sleep at night&#xD;
  &#xD;
            -  Diagnosis of diseases related to the endocrine system (such as diabetes, obesity)&#xD;
  &#xD;
            -  Using hormone replacement medication&#xD;
  &#xD;
            -  Patients using anti-depressant medication were excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Seher Ünver</last_name>
      <role>Principal Investigator</role>
      <affiliation>Trakya University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Esra Çevik</last_name>
      <role>Principal Investigator</role>
      <affiliation>Trakya University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Trakya University</name>
        <address>
          <city>Edirne</city>
          <zip>22030</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>January 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Trakya University</investigator_affiliation>
      <investigator_full_name>Seher Ünver</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>comfort</keyword>
    <keyword>gel pillows</keyword>
    <keyword>sleep quality</keyword>
    <keyword>nursing care</keyword>
    <patient_data>
      <sharing_ipd>No</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/NCT06025136
  org study id: 2022-PO198
  nct id: NCT06025136
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The study was conducted to evaluate the effect of using gel pillows on the sleep quality and
        general comfort levels of patients in the preoperative period.The main hypotheses are:
  
        H1: 'The sleep quality of patients who use gel pillows in the preoperative period is higher
        than those who do not use gel pillows' H2: "The general comfort level of the patients who
        used gel pillows in the preoperative period is higher than those who did not use gel
        pillows".
  
        Participants will be asked to use a gel pillow with a cooling surface the night before the
        day of surgery.
  
        If there is a comparison group: Researchers will compare patients' control group to see if
        there is any difference in sleep quality and comfort levels.
  Randomization method will be used to determine the groups. Randomization of the patients was
        done using the 'Random Allocation Software 2.0' program and they are allocated into 2 groups:
        1) the control group and 2) the intervenion group.
  
          1. The Control Group: The patients in this group will be visited by the researcher in their
             rooms on the morning before the surgery. Patients will be informed that they will be
             visited again in the evening of the day before the surgery and that they will be given a
             pillow to use while sleeping at night. They will receive no other interventions.Patients
             will be visited again on the morning of the surgery day.The Richard Campbell Sleep Scale
             was used to evaluate the nighttime sleep quality of the patients;General Comfort Scale
             to evaluate comfort levels.
  
          2. The Intervenion Group: The patients in this group will be visited by the researcher in
             their rooms on the morning before the surgery. Patients will be informed that they will
             be visited again in the evening of the day before the surgery and that they will be
             given a pillow to use while sleeping at night. Patients who are visited in their rooms
             on the evening of the day before the surgery will be given a gel pillow with a cooling
             surface feature for night use. If patients stop using pillows at night, they will be
             asked to inform the investigator when they come to their room in the morning.Patients
             will be visited again on the morning of the surgery day.The Richard Campbell Sleep Scale
             was used to evaluate the nighttime sleep quality of the patients;General Comfort Scale
             to evaluate comfort levels.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The research will be conducted using randomized controlled, experimental type and single-blind research methods. For this purpose, after the data are collected, they will be coded as A and B groups, so the researcher who will make the research statistics will analyze the data without knowing the study and control groups. Randomization method will be used to determine the groups. For this, the patients who meet the study criteria and volunteer will be assigned to the groups using the randomization program 'Random Allocation Software 2.0' according to the order of hospitalization.
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  masking description: The data analyse is going to be completed by a independent researcher.
  measure: Sleep quality level
  time frame: 12 mounth
  description: Sleep quality of the patietns will be evaluated with Richards Campbell Sleep Scale. Each item in the scale is evaluated on a chart between 0 and 100 using the visual analog scale technique. The total score of the scale is evaluated over 5 items, and the 6th item, which evaluates the noise level in the environment, is excluded from the total score evaluation. A score of "0-25" from the scale indicates very bad sleep, and a score of "76-100" indicates very good sleep. The high score of the scale indicates that the sleep quality of the patients is high.
  measure: Comfort level
  time frame: 12 mounth
  description: Comfort level of the patietns will be evalueated with General Comfort Scale. The lowest total score that can be obtained from the scale is 48, and the highest total score is 192. The average value is determined by dividing the total score obtained by the number of scale items, and the result is indicated in the 1-4 distribution. Low comfort is expressed by one point, high comfort by four points.
  arm group label: Intervention Group
  arm group type: Experimental
  description: Patients who are visited in their rooms on the evening of the day before the surgery will be given a gel pillow with a cooling surface feature for night use. Patients will be asked to note the time they go to bed for a night's sleep and the time they wake up on the morning of the surgery. If patients stop using pillows at night, they will be asked to inform the investigator when they come to their room in the morning.Patients will be visited again on the morning of the surgery day.The Richard Campbell Sleep Scale was used to evaluate the nighttime sleep quality of the patients;General Comfort Scale to evaluate comfort.
  arm group label: Control Group
  arm group type: No Intervention
  description: The patients who were visited in their rooms on the evening of the day before the operation will be given pillows that have the same characteristics as the pillows that the patients in the study group will use, but do not have a gel surface, to use at night. Patients will be asked to note the time they go to bed for a night's sleep and the time they wake up on the morning of the surgery.Participants in the control group will receive no other interventions.Patients will be visited again on the morning of the surgery day.The Richard Campbell Sleep Scale was used to evaluate the nighttime sleep quality of the patients;General Comfort Scale to evaluate comfort levels.
  intervention type: Other
  intervention name: Using a gel pillow
  description: Within the scope of the study, gel pillows with a cold surface were used in the patients in the study group. It is produced by combining the obtained special liquid with elastic material with NASA approved molecule exchange technology and is made of OEKO-TEX CLASS 1 certified material.Thanks to the gel material on the pillow surface, the surface temperature is reduced from 37°C to 24°C in about 10 seconds. It gives a feeling of coolness with its thermal conductivity feature.
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Seher Ünver
  role: Principal Investigator
  affiliation: Trakya University
  last name: Esra Çevik
  role: Principal Investigator
  affiliation: Trakya University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Trakya University
  investigator full name: Seher Ünver
  investigator title: Associate Professor
  sharing ipd: No