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/NCT05988164</url>
    </required_header>
    <id_info>
      <org_study_id>SAU-FHS-KI-02</org_study_id>
      <nct_id>NCT05988164</nct_id>
    </id_info>
    <brief_title>&quot;Eye Masks and Post-Surgical Sleep Quality&quot;</brief_title>
    <acronym>SEM</acronym>
    <official_title>&quot;The Effect of Eye Masks Following Post-Gynecological Surgery on Sleep Quality: A Randomized Study&quot;</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sakarya University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sakarya 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>
        The aim of this study is to evaluate the impact of postoperative eye mask usage on sleep&#xD;
        quality in patients who have undergone gynecological surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sleep is considered a fundamental need for human health, and it contributes significantly to&#xD;
        immune, mental, and physical functions. It has been shown that sleep quality influences&#xD;
        individuals' quality of life, and it also promotes the healing process of injured tissues&#xD;
        Sleep and rest are essential for optimal performance. In adults, 6-8 hours of sleep per day&#xD;
        is required. Along with many unknown aspects of sleep's role in health and diseases, sleep&#xD;
        deprivation is directly associated with poor mental and physical functions. In addition to&#xD;
        compromising individuals' and public health, sleep deprivation can have severe complications&#xD;
        for physical and behavioral functions.&#xD;
  &#xD;
        Various factors contribute to sleep disturbances in the hospital environment. Sleep quality&#xD;
        can be adversely affected by noise, light, and many other aspects of the surrounding&#xD;
        environment. Non-pharmacological and pharmacological treatments can be used to improve sleep&#xD;
        quality. Generally, non-invasive and cost-effective intervention methods are being used in&#xD;
        hospitals to improve the quality of sleep during hospitalizing patients. Several studies have&#xD;
        shown that using non-invasive tools like eye masks positively affects sleep quality.&#xD;
        Nevertheless, there is no evidence that this tool is effective in patients undergoing&#xD;
        gynecological surgery, and no studies have been founded locally to address this issue.&#xD;
        Therefore, this study aims to examine sleep quality in women following gynecological surgery&#xD;
        with eye masks.&#xD;
  &#xD;
        Method:&#xD;
  &#xD;
        A quasi-experimental design with a pre-test and post-test control group approach was used in&#xD;
        this study. The quasi-experiment method uses a control group for experimental research. Two&#xD;
        groups were randomly selected. There is an intervention group and a control group.&#xD;
        Twenty-five participants participated in the intervention and 25 in the control group.&#xD;
  &#xD;
        Patients in the intervention group will be given eye masks and asked to sleep with them at&#xD;
        22:00 or earlier. Researchers or nurses will assist patients who cannot wear an eye mask at&#xD;
        night. The Richard-Campbell Sleep Scale will be used to measure patients' perceptions of&#xD;
        sleep quality. The control group will undergo no intervention, and their sleep quality will&#xD;
        be measured in the hospital setting using the Richard-Campbell Sleep Scale. Richards&#xD;
        developed the Richard-Campbell Sleep Scale (RCSS) in 1987, and Karaman Zlü and Zer conducted&#xD;
        its Turkish validity and reliability study in 2015. The scale consists of six items that&#xD;
        evaluate the depth of nocturnal sleep, sleep onset latency, frequency of awakenings, duration&#xD;
        of wakefulness after sleep onset, sleep quality, and noise level in the environment. Scale&#xD;
        items are evaluated from 0 to 100 on a visual analog scale. Scores between &quot;0-25&quot; indicate&#xD;
        very poor sleep, while scores between &quot;76-100&quot; indicate very good sleep. Participants'&#xD;
        demographic characteristics, such as age, gender, narcotic drug consumption, average sleep&#xD;
        duration before hospitalization, and sleep-facilitating tools, will be recorded on a&#xD;
        participant information form developed in accordance with the literature. The post-test&#xD;
        Richard-Campbell Sleep Scale will be used in the morning to assess sleep quality.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">August 5, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 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>There is an intervention group and a control group. Twenty-five participants participated in the intervention and 25 in the control group. Patients in the intervention group will be given eye masks and asked to sleep with them</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>An independent statistician researcher, not directly involved in collecting patient data, will analyze the data to mask the investigator's influence.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Improving sleep quality with eye mask following gynecological surgery</measure>
      <time_frame>9 months</time_frame>
      <description>Sleep quality and duration are increased in patients undergoing gynecological surgery with the use of postoperative eye masks. This results in reduced sleep interruptions and improved overall healthcare satisfaction and well-being of patients.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Sleep Quality</condition>
    <arm_group>
      <arm_group_label>Eye mask Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in the intervention group will be given eye masks and asked to sleep with them at 22:00 or earlier. Researchers or nurses will assist patients who cannot wear an eye mask at night. To measure patients' perception of sleep quality, we will use the Richard-Campbell Sleep Scale. The following morning, we will complete the post-test Richard-Campbell Sleep Scale to assess sleep quality.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group will undergo no intervention, and their sleep quality will be measured in the hospital setting using the Richard-Campbell Sleep Scale.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Eye Mask</intervention_name>
      <description>Patients in the intervention group will be given eye masks and asked to sleep with them at 22:00 or earlier.</description>
      <arm_group_label>Eye mask Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women who have undergone gynecological surgery Ability to read and speak Turkish&#xD;
               participation with the ability to use an eye mask Patients who recovered at least six&#xD;
               hours after surgery Patients with no traumatic or pathological head injury history&#xD;
               Patients without sleep disorders or mental illnesses&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with an eye injury Patients who are allergic to eye masks Patients or their&#xD;
               families who wish to withdraw from the study Patients with a mental or physical&#xD;
               condition that makes participation in the study impossible.&#xD;
  &#xD;
          Patients who cannot speak or read Turkish&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Only females aged 25-85 who underwent gynecological surgery are eligible to participate in this study..</gender_description>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Sakarya University</name>
        <address>
          <city>Sakarya</city>
          <zip>54050</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 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 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>Sakarya University</investigator_affiliation>
      <investigator_full_name>Dr. Kevser Ozdemir</investigator_full_name>
      <investigator_title>Assosiated Professor</investigator_title>
    </responsible_party>
    <keyword>Eye Mask</keyword>
    <keyword>Sleep Quality</keyword>
    <keyword>Gynecological Surgeries</keyword>
    <keyword>Hospitalization</keyword>
    <keyword>Health Care</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>According to our ethics committee rules, there is no plan to make individual participant data (IPD) available to other researchers.</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/NCT05988164
  org study id: SAU-FHS-KI-02
  nct id: NCT05988164
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the impact of postoperative eye mask usage on sleep
        quality in patients who have undergone gynecological surgery.
  Sleep is considered a fundamental need for human health, and it contributes significantly to
        immune, mental, and physical functions. It has been shown that sleep quality influences
        individuals' quality of life, and it also promotes the healing process of injured tissues
        Sleep and rest are essential for optimal performance. In adults, 6-8 hours of sleep per day
        is required. Along with many unknown aspects of sleep's role in health and diseases, sleep
        deprivation is directly associated with poor mental and physical functions. In addition to
        compromising individuals' and public health, sleep deprivation can have severe complications
        for physical and behavioral functions.
  
        Various factors contribute to sleep disturbances in the hospital environment. Sleep quality
        can be adversely affected by noise, light, and many other aspects of the surrounding
        environment. Non-pharmacological and pharmacological treatments can be used to improve sleep
        quality. Generally, non-invasive and cost-effective intervention methods are being used in
        hospitals to improve the quality of sleep during hospitalizing patients. Several studies have
        shown that using non-invasive tools like eye masks positively affects sleep quality.
        Nevertheless, there is no evidence that this tool is effective in patients undergoing
        gynecological surgery, and no studies have been founded locally to address this issue.
        Therefore, this study aims to examine sleep quality in women following gynecological surgery
        with eye masks.
  
        Method:
  
        A quasi-experimental design with a pre-test and post-test control group approach was used in
        this study. The quasi-experiment method uses a control group for experimental research. Two
        groups were randomly selected. There is an intervention group and a control group.
        Twenty-five participants participated in the intervention and 25 in the control group.
  
        Patients in the intervention group will be given eye masks and asked to sleep with them at
        22:00 or earlier. Researchers or nurses will assist patients who cannot wear an eye mask at
        night. The Richard-Campbell Sleep Scale will be used to measure patients' perceptions of
        sleep quality. The control group will undergo no intervention, and their sleep quality will
        be measured in the hospital setting using the Richard-Campbell Sleep Scale. Richards
        developed the Richard-Campbell Sleep Scale (RCSS) in 1987, and Karaman Zlü and Zer conducted
        its Turkish validity and reliability study in 2015. The scale consists of six items that
        evaluate the depth of nocturnal sleep, sleep onset latency, frequency of awakenings, duration
        of wakefulness after sleep onset, sleep quality, and noise level in the environment. Scale
        items are evaluated from 0 to 100 on a visual analog scale. Scores between "0-25" indicate
        very poor sleep, while scores between "76-100" indicate very good sleep. Participants'
        demographic characteristics, such as age, gender, narcotic drug consumption, average sleep
        duration before hospitalization, and sleep-facilitating tools, will be recorded on a
        participant information form developed in accordance with the literature. The post-test
        Richard-Campbell Sleep Scale will be used in the morning to assess sleep quality.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: There is an intervention group and a control group. Twenty-five participants participated in the intervention and 25 in the control group. Patients in the intervention group will be given eye masks and asked to sleep with them
  primary purpose: Health Services Research
  masking: Single (Investigator)
  masking description: An independent statistician researcher, not directly involved in collecting patient data, will analyze the data to mask the investigator's influence.
  measure: Improving sleep quality with eye mask following gynecological surgery
  time frame: 9 months
  description: Sleep quality and duration are increased in patients undergoing gynecological surgery with the use of postoperative eye masks. This results in reduced sleep interruptions and improved overall healthcare satisfaction and well-being of patients.
  arm group label: Eye mask Group
  arm group type: Experimental
  description: Patients in the intervention group will be given eye masks and asked to sleep with them at 22:00 or earlier. Researchers or nurses will assist patients who cannot wear an eye mask at night. To measure patients' perception of sleep quality, we will use the Richard-Campbell Sleep Scale. The following morning, we will complete the post-test Richard-Campbell Sleep Scale to assess sleep quality.
  arm group label: control Group
  arm group type: No Intervention
  description: The control group will undergo no intervention, and their sleep quality will be measured in the hospital setting using the Richard-Campbell Sleep Scale.
  intervention type: Other
  intervention name: Eye Mask
  description: Patients in the intervention group will be given eye masks and asked to sleep with them at 22:00 or earlier.
  arm group label: Eye mask Group
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Only females aged 25-85 who underwent gynecological surgery are eligible to participate in this study..
  minimum age: 25 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Sakarya University
  investigator full name: Dr. Kevser Ozdemir
  investigator title: Assosiated Professor
  sharing ipd: No
  ipd description: According to our ethics committee rules, there is no plan to make individual participant data (IPD) available to other researchers.