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

December 11, 2024 updated by: Annette Nasr, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aromatherapy
Patients will be given STILL QuickTAB Medipack blended scent aromatherapy in addition to standard supportive measures, which include numbing cream, Child Life support, distraction, caregiver hold, or any combination of these, based on patient preference.
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.
No Intervention: Control Group
Participants will be offered standard supportive measures, which include numbing cream, Child Life support, distraction, caregiver hold, or any combination of these, based on patient preference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of aromatherapy on post patient anxiety scores
Time Frame: 5 minutes

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of aromatherapy on post patient port pain scores
Time Frame: up to 7 minutes
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aromatherapy effect according to age
Time Frame: up to 7 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Study Director: Annette Nasr, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2023

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

January 13, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-68138
  • PEDSVAR0068 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe