<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/NCT04428164</url>
  </required_header>
  <id_info>
    <org_study_id>075.NUR.2019.A</org_study_id>
    <nct_id>NCT04428164</nct_id>
  </id_info>
  <brief_title>Enhancing Patient Experience of Pain and Sleep Through Non-Pharmacological Strategies</brief_title>
  <official_title>Enhancing Patient Experience of Pain and Sleep Through Non-Pharmacological Strategies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Methodist Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Methodist Health System</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>
      Comfort can be a physical sensation, a psychological state, or both simultaneously . Patient&#xD;
      comfort in an inpatient setting is a subjective state that varies from each individual based&#xD;
      on different factors and situations. The Richards-Campbell Sleep Questionnaire (R-CSQ) and&#xD;
      the Revised American Pain Society Outcome Questionnaire (APS-POQ-R) are tools that have been&#xD;
      developed to assess patient satisfaction and comfort in the hospital setting. The R-CSQ is a&#xD;
      scale used to measure different aspects of sleep quality. This scale allows the patient to&#xD;
      rate their quality and amount of sleep on a scale of 0-100. The R-CSQ allows the patient to&#xD;
      rate six different components of their sleep, including sleep depth, sleep latency,&#xD;
      awakenings, returning to sleep, sleep quality, and noise. The APS-POQ-R can be utilized to&#xD;
      measure perceived levels of pain in patients. The APS-POQ-R scale is a validated scale that&#xD;
      is used in the hospital setting with reliable and consistent results. This scale measures&#xD;
      five aspects of a patient's perception and experiences with pain and a sixth aspect including&#xD;
      nonpharmacological interventions.&#xD;
&#xD;
      We propose that if patients implement interventions that promote sleep and decrease pain,&#xD;
      comfort will be improved.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim(s)/Objective(s)&#xD;
&#xD;
        -  Improve patient sleep during their hospital stay.&#xD;
&#xD;
        -  Determine patient self-reported pain assessment using non-pharmacologic strategies.&#xD;
&#xD;
        -  Determine if the &quot;patient toolkit&quot; improves patient experience of pain and sleep.&#xD;
&#xD;
      Hypothesis 1. Primary Hypothesis Patients' experience of pain and sleep will improve with the&#xD;
      implementation of interventions from our &quot;patient toolkit&quot;.&#xD;
&#xD;
      .2. Secondary Hypothesis Patients will report an increase in sleep and a decrease in pain&#xD;
      after use of the interventions provided in the &quot;patient toolkit&quot;.&#xD;
&#xD;
      3. Tertiary Hypothesis Patients will report satisfaction with results gained through&#xD;
      implementation of our &quot;patient toolkit&quot;.&#xD;
&#xD;
      STUDY DESIGN&#xD;
&#xD;
        -  60 to 80 medical surgical patients per campus (MCMC, MDMC, MMMC, MRMC) will be recruited&#xD;
           to participate (total: 240 to 320 patients) Only adult medical surgical patients over&#xD;
           the age 20 will be recruited.&#xD;
&#xD;
        -  Quasi-experimental, pre-/post-test, repeated measures interventional study&#xD;
&#xD;
        -  Length of patients hospital stay will determine length of intervention used; average&#xD;
           estimate is a four-day length of stay&#xD;
&#xD;
        -  Give pre-assessment the morning after first night of admission (Day 2)&#xD;
&#xD;
        -  Participants will receive a toolkit upon informed consent completion that will include&#xD;
           intervention strategies (eye mask; ear plugs; puzzle book; adult coloring book; colored&#xD;
           pencils; aromatherapy patches; herbal tea bags) and data collection booklet for&#xD;
           pre-survey, daily survey, and post-survey&#xD;
&#xD;
        -  Data will be collected over 6 to 10 weeks to achieve desired number of participants&#xD;
&#xD;
        -  Anticipated completion of study will be December 2021&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">February 15, 2022</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Perception of Pain</measure>
    <time_frame>From January 2021 until December 2021</time_frame>
    <description>The Revised American Pain Society Patient Outcome Questionnaire will measure patient perception of pain. This scale measures five aspects of patient's perception and experiences with pain and a sixth aspect including nonpharmacological interventions. The scale goes from (0) - No pain to (10) - Worst Pain Possible</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>From January 2021 until December 2021</time_frame>
    <description>The Richards-Campbell Sleep Questionnaire (R-CSQ) will measure different aspects of sleep quality. The R-CSQ allows the patient to rate six different components of their sleep, including sleep depth, sleep latency, awakenings, returning to sleep, sleep quality, and noise.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">320</enrollment>
  <condition>Comfort</condition>
  <arm_group>
    <arm_group_label>Hospitalized patients</arm_group_label>
    <description>Any patient admitted to the study units (MDMC: 10ST; MCMC: A6; MMMC: A3; MRMC: 3Medical ) that do not have any of the exclusion criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The Richards-Campbell Sleep Questionnaire (R-CSQ)</intervention_name>
    <description>Tool developed to assess patient satisfaction and comfort in the hospital setting.&#xD;
The R-CSQ is a scale used to measure different aspects of sleep quality. This scale allows the patient to rate their quality and amount of sleep on a scale of 0-100. The R-CSQ allows the patient to rate six different components of their sleep, including sleep depth, sleep latency, awakenings, returning to sleep, sleep quality, and noise.</description>
    <arm_group_label>Hospitalized patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Revised American Pain Society Outcome Questionnaire (APS-POQ-R)</intervention_name>
    <description>The APS-POQ-R can be utilized to measure perceived levels of pain in patients. The APS-POQ-R scale is a validated scale that is used in the hospital setting with reliable and consistent results. This scale measures five aspects of a patient's perception and experiences with pain and a sixth aspect including nonpharmacological interventions.</description>
    <arm_group_label>Hospitalized patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        60 to 80 medical surgical patients per campus (MCMC, MDMC, MMMC, MRMC) will be recruited to&#xD;
        participate (total: 240 to 320 patients) Only adult medical surgical patients over the age&#xD;
        20 will be recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Hospitals eligible to participate will meet the following criteria:&#xD;
&#xD;
          -  Part of the MHS (MCMC, MDMC, MMMC, MRMC)&#xD;
&#xD;
          -  The hospital has at least one clinical site/sub-investigator on-staff&#xD;
&#xD;
          -  Hospital has 150 or more inpatient beds&#xD;
&#xD;
        Patients eligible to participate will meet the following criteria:&#xD;
&#xD;
          -  Any patient admitted to the study units (MDMC: 10ST; MCMC: A6; MMMC: A3; MRMC:&#xD;
             3Medical ) that do not have any of the exclusion criteria described below&#xD;
&#xD;
          -  Age: 20+ y/o&#xD;
&#xD;
          -  Must be able to speak/read/write/understand English&#xD;
&#xD;
          -  Willing to utilize study interventions and complete survey booklet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Hospitals outside of MHS will be excluded.&#xD;
&#xD;
        Patients will be excluded for the following reasons:&#xD;
&#xD;
          -  Patients admitted for surgical procedure&#xD;
&#xD;
          -  Change in clinical status and deterioration requiring higher level care&#xD;
&#xD;
          -  Altered mental status&#xD;
&#xD;
          -  Any history of dementia and/or Alzheimer's&#xD;
&#xD;
          -  Disoriented/confused&#xD;
&#xD;
          -  Patients suffering with chronic pain&#xD;
&#xD;
          -  Patients on patient-controlled analgesia&#xD;
&#xD;
          -  Observation status patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Sweatt, MSN, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Methodist Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Methodist Health System</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>March 3, 2022</last_update_submitted>
  <last_update_submitted_qc>March 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04428164
org study id: 075.NUR.2019.A
nct id: NCT04428164
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comfort can be a physical sensation, a psychological state, or both simultaneously . Patient
      comfort in an inpatient setting is a subjective state that varies from each individual based
      on different factors and situations. The Richards-Campbell Sleep Questionnaire (R-CSQ) and
      the Revised American Pain Society Outcome Questionnaire (APS-POQ-R) are tools that have been
      developed to assess patient satisfaction and comfort in the hospital setting. The R-CSQ is a
      scale used to measure different aspects of sleep quality. This scale allows the patient to
      rate their quality and amount of sleep on a scale of 0-100. The R-CSQ allows the patient to
      rate six different components of their sleep, including sleep depth, sleep latency,
      awakenings, returning to sleep, sleep quality, and noise. The APS-POQ-R can be utilized to
      measure perceived levels of pain in patients. The APS-POQ-R scale is a validated scale that
      is used in the hospital setting with reliable and consistent results. This scale measures
      five aspects of a patient's perception and experiences with pain and a sixth aspect including
      nonpharmacological interventions.

      We propose that if patients implement interventions that promote sleep and decrease pain,
      comfort will be improved.
Aim(s)/Objective(s)

        -  Improve patient sleep during their hospital stay.

        -  Determine patient self-reported pain assessment using non-pharmacologic strategies.

        -  Determine if the "patient toolkit" improves patient experience of pain and sleep.

      Hypothesis 1. Primary Hypothesis Patients' experience of pain and sleep will improve with the
      implementation of interventions from our "patient toolkit".

      .2. Secondary Hypothesis Patients will report an increase in sleep and a decrease in pain
      after use of the interventions provided in the "patient toolkit".

      3. Tertiary Hypothesis Patients will report satisfaction with results gained through
      implementation of our "patient toolkit".

      STUDY DESIGN

        -  60 to 80 medical surgical patients per campus (MCMC, MDMC, MMMC, MRMC) will be recruited
           to participate (total: 240 to 320 patients) Only adult medical surgical patients over
           the age 20 will be recruited.

        -  Quasi-experimental, pre-/post-test, repeated measures interventional study

        -  Length of patients hospital stay will determine length of intervention used; average
           estimate is a four-day length of stay

        -  Give pre-assessment the morning after first night of admission (Day 2)

        -  Participants will receive a toolkit upon informed consent completion that will include
           intervention strategies (eye mask; ear plugs; puzzle book; adult coloring book; colored
           pencils; aromatherapy patches; herbal tea bags) and data collection booklet for
           pre-survey, daily survey, and post-survey

        -  Data will be collected over 6 to 10 weeks to achieve desired number of participants

        -  Anticipated completion of study will be December 2021
observational model: Other
time perspective: Prospective
measure: Patient Perception of Pain
time frame: From January 2021 until December 2021
description: The Revised American Pain Society Patient Outcome Questionnaire will measure patient perception of pain. This scale measures five aspects of patient's perception and experiences with pain and a sixth aspect including nonpharmacological interventions. The scale goes from (0) - No pain to (10) - Worst Pain Possible
measure: Sleep Quality
time frame: From January 2021 until December 2021
description: The Richards-Campbell Sleep Questionnaire (R-CSQ) will measure different aspects of sleep quality. The R-CSQ allows the patient to rate six different components of their sleep, including sleep depth, sleep latency, awakenings, returning to sleep, sleep quality, and noise.
arm group label: Hospitalized patients
description: Any patient admitted to the study units (MDMC: 10ST; MCMC: A6; MMMC: A3; MRMC: 3Medical ) that do not have any of the exclusion criteria
intervention type: Other
intervention name: The Richards-Campbell Sleep Questionnaire (R-CSQ)
description: Tool developed to assess patient satisfaction and comfort in the hospital setting.
The R-CSQ is a scale used to measure different aspects of sleep quality. This scale allows the patient to rate their quality and amount of sleep on a scale of 0-100. The R-CSQ allows the patient to rate six different components of their sleep, including sleep depth, sleep latency, awakenings, returning to sleep, sleep quality, and noise.
arm group label: Hospitalized patients
intervention type: Other
intervention name: Revised American Pain Society Outcome Questionnaire (APS-POQ-R)
description: The APS-POQ-R can be utilized to measure perceived levels of pain in patients. The APS-POQ-R scale is a validated scale that is used in the hospital setting with reliable and consistent results. This scale measures five aspects of a patient's perception and experiences with pain and a sixth aspect including nonpharmacological interventions.
arm group label: Hospitalized patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Laura Sweatt, MSN, RN
role: Principal Investigator
affiliation: Methodist Health System
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No