Impact of Aromatherapy on Nausea in Hospitalized Children Undergoing Rehabilitation

NCT06009211 | Enrolling By Invitation

• 1 other identifier: 275439
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea

Keywords

kids; nausea; aromatherapy; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Symptoms of Nausea

  Two week duration

• Change in Nausea

  Two week duration

Study Arms (1)

Aromatherapy

Randomized crossover research study

Other: QueaseEase

Interventions

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.

Aromatherapy

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Related 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.

  PMID: 31185115 BACKGROUND

• 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.

  PMID: 21624874 BACKGROUND

• 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.

  PMID: 30265393 BACKGROUND

• 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.

  PMID: 36123297 BACKGROUND

• 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.

  PMID: 34905993 BACKGROUND

• 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.

  PMID: 34837806 BACKGROUND

• 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.

  PMID: 31423959 BACKGROUND

MeSH Terms

Conditions

Nausea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laikin Ulrich, BSN

  Arkansas Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Submitted on behalf of Laikin Ulrich, RN IV Care Coordinator, Acute Care Rehabilitation

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 24, 2023
• Study Start: January 23, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)