Clinical trial NCT06009211: Impact of Aromatherapy on Nausea in Hospitalized Children Undergoing Rehabilitation
Official title: Impact of Aromatherapy on Nausea in Hospitalized Children Undergoing Rehabilitation: A Nurse-led Approach
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Nausea
Keywords: kids
nausea
aromatherapy
rehabilitation
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Wellbeing
timeFrame: Two week duration
Secondary outcomes:
measure: Symptoms of Nausea
timeFrame: Two week duration
measure: Change in Nausea
timeFrame: Two week duration
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: Arkansas Children's Hospital Research Institute
name: Laikin Ulrich, BSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arruda J, Yeh AM. Integrative Approach to Pediatric Nausea. Pediatr Ann. 2019 Jun 1;48(6):e236-e242. doi: 10.3928/19382359-20190517-01.
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.
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.
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.
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.
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.
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.