[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06009211":3,"trial-entities:NCT06009211":106,"trial-summary:NCT06009211":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":42,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":15,"eligibility_criteria":52,"std_ages":65,"locations":67,"central_contacts":77,"overall_officials":78,"references":82,"see_also_links":105},"NCT06009211","275439","Impact of Aromatherapy on Nausea in Hospitalized Children Undergoing Rehabilitation","Impact of Aromatherapy on Nausea in Hospitalized Children Undergoing Rehabilitation: A Nurse-led Approach","ENROLLING_BY_INVITATION","2027-05-01","2024-07","2024-07-18","2024-01-23","Arkansas Children's Hospital Research Institute","OTHER",false,"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.\n\nIf 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.\n\nChildren participating in the study may or may not help the child but may help children in the future:\n\n1. 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.\n2. Children may have a reduction in the need for taking medications that help nausea.\n3. The research may benefit children in the future by helping to develop hospital practices about using aromatherapy in pediatric rehabilitation.",[19],"Nausea",[21,22,23,24],"kids","nausea","aromatherapy","rehabilitation","OBSERVATIONAL",null,[],{"count":29,"type":30},10,"ESTIMATED",[32],{"type":14,"name":33,"description":34,"armGroupLabels":35},"QueaseEase","Study participants will participate in one week with aromatherapy treatment and one week without aromatherapy treatment (randomly ordered) to serve as their own control.",[36],"Aromatherapy",[38],{"measure":39,"description":40,"timeFrame":41},"Overall Wellbeing","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?\n\nThe 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).","Two week duration",[43,46],{"measure":44,"description":45,"timeFrame":41},"Symptoms of Nausea","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.\n\nThe 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":47,"description":48,"timeFrame":41},"Change in Nausea","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.\n\nThe 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).","ALL","8 Years","17 Years",{"inclusion":53,"exclusion":59,"raw_text":64},[54,55,56,57,58],"Patients ages 8 to 17 years of age on the rehabilitation unit and service at Arkansas Children's Hospital","Patients with a Glascow Coma Scale (GCS) of 13-15","Patients with a Rancho Los Amigos Revised Scale score of 5 or higher","Ability to read and write in English","Patient to have an expected length of stay of at least 2 weeks",[60,61,62,63],"Patients with any mechanical or obstructive pathophysiology (appendicitis, bowel obstruction, or intussusception, etc.)","Known allergy or sensitivity to lavender, peppermint, spearmint, or ginger","Patients with known asthma and\u002For pulmonary conditions","Wards of the State or any other agency or institution","Inclusion Criteria:\n\n* Patients ages 8 to 17 years of age on the rehabilitation unit and service at Arkansas Children's Hospital\n* Patients with a Glascow Coma Scale (GCS) of 13-15\n* Patients with a Rancho Los Amigos Revised Scale score of 5 or higher\n* Ability to read and write in English\n* Patient to have an expected length of stay of at least 2 weeks\n\nExclusion Criteria:\n\n* Patients with any mechanical or obstructive pathophysiology (appendicitis, bowel obstruction, or intussusception, etc.)\n* Known allergy or sensitivity to lavender, peppermint, spearmint, or ginger\n* Patients with known asthma and\u002For pulmonary conditions\n* Wards of the State or any other agency or institution",[66],"CHILD",[68],{"facility":69,"city":70,"state":71,"zip":72,"country":73,"geoPoint":74},"Arkansas Children's Hospital","Little Rock","Arkansas","72202","United States",{"lat":75,"lon":76},34.74648,-92.28959,[],[79],{"name":80,"affiliation":13,"role":81},"Laikin Ulrich, BSN","PRINCIPAL_INVESTIGATOR",[83,87,90,93,96,99,102],{"pmid":84,"type":85,"citation":86},"31185115","BACKGROUND","Arruda J, Yeh AM. Integrative Approach to Pediatric Nausea. Pediatr Ann. 2019 Jun 1;48(6):e236-e242. doi: 10.3928\u002F19382359-20190517-01.",{"pmid":88,"type":85,"citation":89},"21624874","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\u002Fpeds.2010-1410. Epub 2011 May 29.",{"pmid":91,"type":85,"citation":92},"30265393","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\u002Faorn.12366.",{"pmid":94,"type":85,"citation":95},"36123297","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\u002Fj.pmn.2022.08.003. Epub 2022 Sep 16.",{"pmid":97,"type":85,"citation":98},"34905993","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\u002F08980101211065555. Epub 2021 Dec 15.",{"pmid":100,"type":85,"citation":101},"34837806","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\u002Fj.ctcp.2021.101516. Epub 2021 Nov 23.",{"pmid":103,"type":85,"citation":104},"31423959","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\u002FS1478951519000555.",[],{"nct_id":4,"conditions":107,"biomarkers":108},[19],[],{"nct_id":4,"found":15,"summary":26,"prompt_version":26}]