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/NCT06009211</url>
    </required_header>
    <id_info>
      <org_study_id>275439</org_study_id>
      <nct_id>NCT06009211</nct_id>
    </id_info>
    <brief_title>Impact of Aromatherapy on Nausea in Hospitalized Children Undergoing Rehabilitation</brief_title>
    <official_title>Impact of Aromatherapy on Nausea in Hospitalized Children Undergoing Rehabilitation: A Nurse-led Approach</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Arkansas Children's Hospital Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Arkansas Children's Hospital Research Institute</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>
        Children, ages 8 - 17, will be enrolled in a research study about the impact of aromatherapy&#xD;
        on nausea in the pediatric rehabilitation unit.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Children will participate in the study for two weeks. One week the child will receive a&#xD;
        aromatherapy product for nausea and the other week the child will not receive the product.&#xD;
  &#xD;
        If this aromatherapy is effective at decreasing nausea, the child may be more likely to&#xD;
        participate in their rehabilitation therapy sessions. Information gathered during the study&#xD;
        may potentially benefit other patients by helping to develop hospital practices of using&#xD;
        aromatherapy in the pediatric rehabilitation unit.&#xD;
  &#xD;
        Children participating in the study may or may not help the child but may help children in&#xD;
        the future:&#xD;
  &#xD;
          1. Children may have less nausea, which could help them feel better, more likely to&#xD;
             participate in their rehabilitation activities, and may be able to take better care of&#xD;
             themselves.&#xD;
  &#xD;
          2. Children may have a reduction in the need for taking medications that help nausea.&#xD;
  &#xD;
          3. The research may benefit children in the future by helping to develop hospital practices&#xD;
             about using aromatherapy in pediatric rehabilitation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">May 1, 2024</start_date>
    <completion_date type="Anticipated">May 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Overall Wellbeing</measure>
      <time_frame>Two week duration</time_frame>
      <description>Is there an improvement in overall wellbeing as evidenced by a rate of change in nausea with the implementation of aromatherapy in pediatric patients on an inpatient rehabilitation unit?&#xD;
  The Baxter Animated Retching Faces (BARF) scale will be used along with a patient diary where patients record how they are feeling. The BARF scale has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more nausea).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Symptoms of Nausea</measure>
      <time_frame>Two week duration</time_frame>
      <description>To measure the impact of aromatherapy on the overall wellbeing, specifically the symptoms associated with nausea, of pediatric patients on the inpatient rehabilitation unit measured by the Baxter Animated Retching Faces (BARF) scale as compared to standard therapy.&#xD;
  The Baxter Animated Retching Faces (BARF) scale will be used along with a patient diary where patients record how they are feeling. The BARF scale has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more nausea).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Nausea</measure>
      <time_frame>Two week duration</time_frame>
      <description>To measure the impact of aromatherapy on the overall wellbeing as evidenced by a rate of change in nausea of pediatric patients on the inpatient rehabilitation unit measured by the frequency of antiemetic medication administration as compared to standard therapy.&#xD;
  The Baxter Animated Retching Faces (BARF) scale will be used along with a patient diary where patients record how they are feeling. The BARF scale has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more nausea).</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Nausea</condition>
    <arm_group>
      <arm_group_label>Aromatherapy</arm_group_label>
      <description>Randomized crossover research study</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>QueaseEase</intervention_name>
      <description>Study participants will participate in one week with aromatherapy treatment and one week without aromatherapy treatment (randomly ordered) to serve as their own control.</description>
      <arm_group_label>Aromatherapy</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study will be conducted on a 10 bed pediatric rehabilitation unit at Arkansas&#xD;
          Children's Hospital. The goals of inpatient rehabilitation are to assist patients in&#xD;
          reaching their greatest level of independence and to maximize each child's recovery.&#xD;
          Admission criteria include: 1) a medically stable patient who is able and willing to&#xD;
          actively participate in 3 hours of therapy (combined time for occupational, physical and&#xD;
          speech therapy) per day, 6 days a week; 2) a diagnosis where the patient is expected to&#xD;
          benefit from a comprehensive inpatient interdisciplinary rehabilitation program; and, 3)&#xD;
          established goals that are specific and pertain to improving functional independence. The&#xD;
          top three diagnoses for children admitted to the rehabilitation unit include ABI, TBI, and&#xD;
          spinal cord injury. Other diagnoses include, but are not limited to, amputation, burn&#xD;
          injury, and cerebral palsy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients ages 8 to 17 years of age on the rehabilitation unit and service at Arkansas&#xD;
               Children's Hospital&#xD;
  &#xD;
            -  Patients with a Glascow Coma Scale (GCS) of 13-15&#xD;
  &#xD;
            -  Patients with a Rancho Los Amigos Revised Scale score of 5 or higher&#xD;
  &#xD;
            -  Ability to read and write in English&#xD;
  &#xD;
            -  Patient to have an expected length of stay of at least 2 weeks&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with any mechanical or obstructive pathophysiology (appendicitis, bowel&#xD;
               obstruction, or intussusception, etc.)&#xD;
  &#xD;
            -  Known allergy or sensitivity to lavender, peppermint, spearmint, or ginger&#xD;
  &#xD;
            -  Patients with known asthma and/or pulmonary conditions&#xD;
  &#xD;
            -  Wards of the State or any other agency or institution&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Laikin Ulrich, BSN</last_name>
      <role>Principal Investigator</role>
      <affiliation>Arkansas Children's Hospital Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Laikin Ulrich, BSN</last_name>
      <phone>501-364-1707</phone>
      <email>davisl1@archildrens.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Austin Lovenstein, MBA</last_name>
      <phone>501-364-3254</phone>
      <email>lovensteinam@archildrens.org</email>
    </overall_contact_backup>
    <reference>
      <citation>Arruda J, Yeh AM. Integrative Approach to Pediatric Nausea. Pediatr Ann. 2019 Jun 1;48(6):e236-e242. doi: 10.3928/19382359-20190517-01.</citation>
      <PMID>31185115</PMID>
    </reference>
    <reference>
      <citation>Baxter AL, Watcha MF, Baxter WV, Leong T, Wyatt MM. Development and validation of a pictorial nausea rating scale for children. Pediatrics. 2011 Jun;127(6):e1542-9. doi: 10.1542/peds.2010-1410. Epub 2011 May 29. Erratum In: Pediatrics. 2011 Nov;128(5):1004.</citation>
      <PMID>21624874</PMID>
    </reference>
    <reference>
      <citation>Brown L, Danda L, Fahey TJ 3rd. A Quality Improvement Project to Determine the Effect of Aromatherapy on Postoperative Nausea and Vomiting in a Short-Stay Surgical Population. AORN J. 2018 Oct;108(4):361-369. doi: 10.1002/aorn.12366.</citation>
      <PMID>30265393</PMID>
    </reference>
    <reference>
      <citation>Czarnecki ML, Michlig JR, Norton AM, Stelter AJ, Hainsworth KR. Use of Aromatherapy for Pediatric Surgical Patients. Pain Manag Nurs. 2022 Dec;23(6):703-710. doi: 10.1016/j.pmn.2022.08.003. Epub 2022 Sep 16.</citation>
      <PMID>36123297</PMID>
    </reference>
    <reference>
      <citation>Marsh E, Millette D, Wolfe A. Complementary Intervention in Postoperative Care: Aromatherapy's Role in Decreasing Postoperative Nausea and Vomiting. J Holist Nurs. 2022 Dec;40(4):351-358. doi: 10.1177/08980101211065555. Epub 2021 Dec 15.</citation>
      <PMID>34905993</PMID>
    </reference>
    <reference>
      <citation>Sanchez FA, Rosales JR, Godoy PR, Barria RM. Effects of inhalation aromatherapy as a complementary therapy in pediatric patients in the clinical practice: A systematic review. Complement Ther Clin Pract. 2022 Feb;46:101516. doi: 10.1016/j.ctcp.2021.101516. Epub 2021 Nov 23.</citation>
      <PMID>34837806</PMID>
    </reference>
    <reference>
      <citation>Weaver MS, Robinson J, Wichman C. Aromatherapy improves nausea, pain, and mood for patients receiving pediatric palliative care symptom-based consults: A pilot design trial. Palliat Support Care. 2020 Apr;18(2):158-163. doi: 10.1017/S1478951519000555.</citation>
      <PMID>31423959</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Arkansas Children's Hospital Research Institute</investigator_affiliation>
      <investigator_full_name>AustinLovenstein</investigator_full_name>
      <investigator_title>Submitted on behalf of Laikin Ulrich, RN IV Care Coordinator, Acute Care Rehabilitation</investigator_title>
    </responsible_party>
    <keyword>kids</keyword>
    <keyword>nausea</keyword>
    <keyword>aromatherapy</keyword>
    <keyword>rehabilitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nausea</mesh_term>
    </condition_browse>
    <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/NCT06009211
  org study id: 275439
  nct id: NCT06009211
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Children, ages 8 - 17, will be enrolled in a research study about the impact of aromatherapy
        on nausea in the pediatric rehabilitation unit.
  Children will participate in the study for two weeks. One week the child will receive a
        aromatherapy product for nausea and the other week the child will not receive the product.
  
        If this aromatherapy is effective at decreasing nausea, the child may be more likely to
        participate in their rehabilitation therapy sessions. Information gathered during the study
        may potentially benefit other patients by helping to develop hospital practices of using
        aromatherapy in the pediatric rehabilitation unit.
  
        Children participating in the study may or may not help the child but may help children in
        the future:
  
          1. Children may have less nausea, which could help them feel better, more likely to
             participate in their rehabilitation activities, and may be able to take better care of
             themselves.
  
          2. Children may have a reduction in the need for taking medications that help nausea.
  
          3. The research may benefit children in the future by helping to develop hospital practices
             about using aromatherapy in pediatric rehabilitation.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Overall Wellbeing
  time frame: Two week duration
  description: Is there an improvement in overall wellbeing as evidenced by a rate of change in nausea with the implementation of aromatherapy in pediatric patients on an inpatient rehabilitation unit?
  The Baxter Animated Retching Faces (BARF) scale will be used along with a patient diary where patients record how they are feeling. The BARF scale has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more nausea).
  measure: Symptoms of Nausea
  time frame: Two week duration
  description: To measure the impact of aromatherapy on the overall wellbeing, specifically the symptoms associated with nausea, of pediatric patients on the inpatient rehabilitation unit measured by the Baxter Animated Retching Faces (BARF) scale as compared to standard therapy.
  The Baxter Animated Retching Faces (BARF) scale will be used along with a patient diary where patients record how they are feeling. The BARF scale has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more nausea).
  measure: Change in Nausea
  time frame: Two week duration
  description: To measure the impact of aromatherapy on the overall wellbeing as evidenced by a rate of change in nausea of pediatric patients on the inpatient rehabilitation unit measured by the frequency of antiemetic medication administration as compared to standard therapy.
  The Baxter Animated Retching Faces (BARF) scale will be used along with a patient diary where patients record how they are feeling. The BARF scale has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more nausea).
  arm group label: Aromatherapy
  description: Randomized crossover research study
  intervention type: Other
  intervention name: QueaseEase
  description: Study participants will participate in one week with aromatherapy treatment and one week without aromatherapy treatment (randomly ordered) to serve as their own control.
  arm group label: Aromatherapy
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Laikin Ulrich, BSN
  role: Principal Investigator
  affiliation: Arkansas Children's Hospital Research Institute
  last name: Laikin Ulrich, BSN
  phone: 501-364-1707
  email: davisl1@archildrens.org
  last name: Austin Lovenstein, MBA
  phone: 501-364-3254
  email: lovensteinam@archildrens.org
  citation: Arruda J, Yeh AM. Integrative Approach to Pediatric Nausea. Pediatr Ann. 2019 Jun 1;48(6):e236-e242. doi: 10.3928/19382359-20190517-01.
  PMID: 31185115
  citation: Baxter AL, Watcha MF, Baxter WV, Leong T, Wyatt MM. Development and validation of a pictorial nausea rating scale for children. Pediatrics. 2011 Jun;127(6):e1542-9. doi: 10.1542/peds.2010-1410. Epub 2011 May 29. Erratum In: Pediatrics. 2011 Nov;128(5):1004.
  PMID: 21624874
  citation: Brown L, Danda L, Fahey TJ 3rd. A Quality Improvement Project to Determine the Effect of Aromatherapy on Postoperative Nausea and Vomiting in a Short-Stay Surgical Population. AORN J. 2018 Oct;108(4):361-369. doi: 10.1002/aorn.12366.
  PMID: 30265393
  citation: Czarnecki ML, Michlig JR, Norton AM, Stelter AJ, Hainsworth KR. Use of Aromatherapy for Pediatric Surgical Patients. Pain Manag Nurs. 2022 Dec;23(6):703-710. doi: 10.1016/j.pmn.2022.08.003. Epub 2022 Sep 16.
  PMID: 36123297
  citation: Marsh E, Millette D, Wolfe A. Complementary Intervention in Postoperative Care: Aromatherapy's Role in Decreasing Postoperative Nausea and Vomiting. J Holist Nurs. 2022 Dec;40(4):351-358. doi: 10.1177/08980101211065555. Epub 2021 Dec 15.
  PMID: 34905993
  citation: Sanchez FA, Rosales JR, Godoy PR, Barria RM. Effects of inhalation aromatherapy as a complementary therapy in pediatric patients in the clinical practice: A systematic review. Complement Ther Clin Pract. 2022 Feb;46:101516. doi: 10.1016/j.ctcp.2021.101516. Epub 2021 Nov 23.
  PMID: 34837806
  citation: Weaver MS, Robinson J, Wichman C. Aromatherapy improves nausea, pain, and mood for patients receiving pediatric palliative care symptom-based consults: A pilot design trial. Palliat Support Care. 2020 Apr;18(2):158-163. doi: 10.1017/S1478951519000555.
  PMID: 31423959
  responsible party type: Principal Investigator
  investigator affiliation: Arkansas Children's Hospital Research Institute
  investigator full name: AustinLovenstein
  investigator title: Submitted on behalf of Laikin Ulrich, RN IV Care Coordinator, Acute Care Rehabilitation
  mesh term: Nausea
  sharing ipd: No