Impact of Aromatherapy on Nausea in Hospitalized Children Undergoing Rehabilitation

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06009211
• Other study ID #: 275439
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: May 1, 2026

Study information

• Verified date: August 2023
• Source: Arkansas Children's Hospital Research Institute
• Contact: Laikin Ulrich, BSN
• Phone: 501-364-1707
• Email: davisl1[@]archildrens.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

References & Publications (7)

Arruda J, Yeh AM. Integrative Approach to Pediatric Nausea. Pediatr Ann. 2019 Jun 1;48(6):e236-e242. doi: 10.3928/19382359-20190517-01. — View Citation

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/peds.2010-1410. Epub 2011 May 29. Erratum In: Pediatrics. 2011 Nov;128(5):1004. — View Citation

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/aorn.12366. — View Citation

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/j.pmn.2022.08.003. Epub 2022 Sep 16. — View Citation

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: 10.1177/08980101211065555. Epub 2021 Dec 15. — View Citation

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/j.ctcp.2021.101516. Epub 2021 Nov 23. — View Citation

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/S1478951519000555. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Two week duration
Secondary	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).	Two week duration
Secondary	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).	Two week duration