Impact of Aromatherapy on Nausea in Hospitalized Children Undergoing Rehabilitation

• Conditions: Nausea
• Interventions: Other: QueaseEase

• Registration Number: NCT06009211
• Lead Sponsor: Arkansas Children's Hospital Research Institute

Brief Summary

Children, ages 8 - 17, will be enrolled in a research study about the impact of aromatherapy on nausea in the pediatric rehabilitation unit.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-24
• Study Start: 2024-01-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Primary Completion: 2026-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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

Exclusion Criteria

• 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/or pulmonary conditions
• Wards of the State or any other agency or institution

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aromatherapy	QueaseEase	Randomized crossover research study

Primary Outcome Measures

Name	Time	Method
Overall Wellbeing	Two week duration	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).

Secondary Outcome Measures

Name	Time	Method
Change in Nausea	Two week duration	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).
Symptoms of Nausea	Two week duration	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).

Trial Locations

Locations (1)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States