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Enrolling by Invitation

NCT Number: NCT06009211

Impact of Aromatherapy on Nausea in Hospitalized Children Undergoing Rehabilitation

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

Enrolling by Invitation

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

About this study

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:

  • 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.
  • Children may have a reduction in the need for taking medications that help nausea.
  • The research may benefit children in the future by helping to develop hospital practices about using aromatherapy in pediatric rehabilitation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QueaseEase

Other

Study participants will participate in one week with aromatherapy treatment and one week without aromatherapy treatment (randomly ordered) to serve as their own control.

Primary outcomes

  1. Overall Wellbeing

    Time frame: 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 outcomes

  1. Symptoms of Nausea

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Registry information

Official study title

Impact of Aromatherapy on Nausea in Hospitalized Children Undergoing Rehabilitation: A Nurse-led Approach

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 24, 2023
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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