An observational study in Nausea, sponsored by Arkansas Children's Hospital Research Institute. Enrolling by invitation at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-07-18.
Sponsored by Arkansas Children's Hospital Research Institute · Observational
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:
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's planned enrollment of 10 is below the median of 170 across 90 observational studies indexed under Nausea.
Browse Nausea studies →Arkansas Children's Hospital Research Institute is the lead sponsor of 118 studies on the registry; 27 are open to participants now.
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The study will be conducted on a 10 bed pediatric rehabilitation unit at Arkansas Children's Hospital. The goals of inpatient rehabilitation are to assist patients in reaching their greatest level of independence and to maximize each child's recovery. Admission criteria include: 1) a medically stable patient who is able and willing to actively participate in 3 hours of therapy (combined time for occupational, physical and speech therapy) per day, 6 days a week; 2) a diagnosis where the patient is expected to benefit from a comprehensive inpatient interdisciplinary rehabilitation program; and, 3) established goals that are specific and pertain to improving functional independence. The top three diagnoses for children admitted to the rehabilitation unit include ABI, TBI, and spinal cord injury. Other diagnoses include, but are not limited to, amputation, burn injury, and cerebral palsy.
Exclusion Criteria:
Randomized crossover research study
Other: 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.
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? 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).
Time frame: Two week duration
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. 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).
Time frame: Two week duration
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. 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).
Time frame: Two week duration
Plan to share: No
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Arkansas Children's Hospital Research Institute