Determining the Efficacy of Essential Oil Aromatherapy in Children Undergoing Port Access

Pain Clinical Trial

Official title:

Determining the Efficacy of Essential Oil Aromatherapy in Children Undergoing Port Access

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05696899
• Other study ID #: IRB-68138
• Secondary ID: PEDSVAR0068
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 5, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if the use of aromatherapy impacts patient anxiety and pain scores surrounding port access in pediatric oncology patients between the ages of 4 years and 18 years.

Description:

Specific aims include the following: Aim 1: To compare pre and post port access anxiety scores for both control and intervention groups. Aim 2: To assess pre and post port pain scores surrounding port access for both control and intervention groups. Aim 3: To compare pain and anxiety scores between age groups. The overall goal of this pilot study is to identify if aromatherapy, using non-topical, STILL QuickTAB Medipack blended scent aromatherapy, manufactured by Soothing Scents, is effective as a valid non-pharmacologic supplementation in reducing anxiety and pain scores during port access in pediatric oncology patients.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 115
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Children between 4 years and 18 years

2. Scheduled for port access with or without lab draw

3. Oncology, neuro-oncology, and stem cell transplant patients

Exclusion Criteria:

1. has asthma, reactive airway disease, or allergies to any of the ingredients we are using in the aromatherapy study (lavender, bergamot, sweet orange, and ylang ylang)

2. currently uses aromatherapy for port accesses or other painful procedures (does not apply to patients using aromatherapy, such as peppermint oil, for nausea)

3. has a cognitive impairment that prevents them from being able to provide anxiety or pain scores

4. does not wish to participate in the study

Related Conditions & MeSH terms

• Anxiety and Fear
• Pain

Intervention

Other:
• STILL QuickTAB Medipack blended scent aromatherapy, manufactured by Soothing Scents
A resealable quick-tab dispenser with the 'therapeutic inhaled essential oils' lavender, bergamot, sweet orange, and ylang ylang.

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Bikmoradi A, Khaleghverdi M, Seddighi I, Moradkhani S, Soltanian A, Cheraghi F. Effect of inhalation aromatherapy with lavender essence on pain associated with intravenous catheter insertion in preschool children: A quasi-experimental study. Complement Th — View Citation

Ghaderi F, Solhjou N. The effects of lavender aromatherapy on stress and pain perception in children during dental treatment: A randomized clinical trial. Complement Ther Clin Pract. 2020 Aug;40:101182. doi: 10.1016/j.ctcp.2020.101182. Epub 2020 Apr 28. — View Citation

Kang HJ, Nam ES, Lee Y, Kim M. How Strong is the Evidence for the Anxiolytic Efficacy of Lavender?: Systematic Review and Meta-analysis of Randomized Controlled Trials. Asian Nurs Res (Korean Soc Nurs Sci). 2019 Dec;13(5):295-305. doi: 10.1016/j.anr.2019. — View Citation

Karaman T, Karaman S, Dogru S, Tapar H, Sahin A, Suren M, Arici S, Kaya Z. Evaluating the efficacy of lavender aromatherapy on peripheral venous cannulation pain and anxiety: A prospective, randomized study. Complement Ther Clin Pract. 2016 May;23:64-8. d — View Citation

Kucuk Alemdar D, Yaman Aktas Y. The Use of the Buzzy, Jet Lidokaine, Bubble-blowing and Aromatherapy for Reducing Pediatric Pain, Stress and Fear Associated with Phlebotomy. J Pediatr Nurs. 2019 Mar-Apr;45:e64-e72. doi: 10.1016/j.pedn.2019.01.010. Epub 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Aromatherapy effect according to age	To compare pre and post pain and anxiety scores between the three age groups. The Visual Facial Anxiety Scale will be used to score patient anxiety, with faces corresponding to numerical ratings of 0-10. 0 corresponds with no anxiety and 10 corresponds with the highest level of anxiety. Pain will be scored using the 0-10 Numerical Rating Scale or the Wong-Baker FACES Pain Rating Scale, according to patient preference and age. For both scales, 0 corresponds with no pain and 10 corresponds with the highest pain.	up to 7 minutes
Primary	Effect of aromatherapy on post patient anxiety scores	Comparison of pre and post patient anxiety scores for both control and intervention groups using the Visual Facial Anxiety Scale with corresponding values ranging from 0-10. 0 indicates no anxiety and 10 indicates the highest level of anxiety.; Anxiety score will be measured by using the Visual Facial Anxiety Scale (VFAS)	5 minutes
Secondary	Effect of aromatherapy on post patient port pain scores	Comparison of pre and post patient pain scale for both control and intervention groups using the 0-10 scale or the Wong-Baker FACES Pain Rating Scale, according to patient preference and age appropriate rating. The Wong-Baker FACES Pain Rating Scale has corresponding faces for numerical rankings of 0-10. For both pain scales, 0 indicates no pain and 10 indicates the worst pain.	up to 7 minutes