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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Anxiety and Fear, Pain

Intervention / Treatment
-----------------
* Other: STILL QuickTAB Medipack blended scent aromatherapy, manufactured by Soothing Scents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between 4 years and 18 years Scheduled for port access with or without lab draw Oncology, neuro-oncology, and stem cell transplant patients Exclusion Criteria: 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) currently uses aromatherapy for port accesses or other painful procedures (does not apply to patients using aromatherapy, such as peppermint oil, for nausea) has a cognitive impairment that prevents them from being able to provide anxiety or pain scores does not wish to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aromatherapy<br>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<br>* A resealable quick-tab dispenser with the 'therapeutic inhaled essential oils' lavender, bergamot, sweet orange, and ylang ylang.<br>|
| No Intervention: Control Group<br>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 | Comparison of pre and post patient anxiety scores for both control and intervention groups. Anxiety score will be measured by using the Visual Facial Anxiety Scale (VFAS) | 5 minutes | 
| Effect of aromatherapy on post patient pain scale | Comparison of pre and post patient pain scale for both control and intervention groups. Pain scale will be measured by using, either Wong-Baker Faces or 0 to 10. Score range: 0 to 10 (0 = no pain, 10 = worst pain) | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of aromatherapy on pre and post patient port pain scores | Comparison of pre and post port pain scores surrounding port access for both control and intervention groups. Pain scores will be measured by using either Wong-Baker Faces or 0-10, with higher scores indicating the worst pain level. | up to 7 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aromatherapy, Port-a-Cath, Pediatric