Impact of Aromatherapy on Nausea in Hospitalized Children Undergoing Rehabilitation

Sponsor
Arkansas Children's Hospital Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06009211
Collaborator
(none)
10
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: QueaseEase

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 Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Impact of Aromatherapy on Nausea in Hospitalized Children Undergoing Rehabilitation: A Nurse-led Approach
Anticipated Study Start Date :
May 1, 2024
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Aromatherapy

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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).

  2. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Arkansas Children's Hospital Research Institute

Investigators

  • Principal Investigator: Laikin Ulrich, BSN, Arkansas Children's Hospital Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
AustinLovenstein, Submitted on behalf of Laikin Ulrich, RN IV Care Coordinator, Acute Care Rehabilitation, Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT06009211
Other Study ID Numbers:
  • 275439
First Posted:
Aug 24, 2023
Last Update Posted:
Aug 24, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by AustinLovenstein, Submitted on behalf of Laikin Ulrich, RN IV Care Coordinator, Acute Care Rehabilitation, Arkansas Children's Hospital Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2023