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

Not Applicable

Completed

• Conditions: Anxiety and Fear; Pain
• Interventions: Other: STILL QuickTAB Medipack blended scent aromatherapy, manufactured by Soothing Scents

• Registration Number: NCT05696899
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2023-01-13
• Study First Submitted QC: 2023-01-23
• Study First Posted: 2023-01-25
• Study Start: 2023-12-05
• Primary Completion: 2024-05-30
• Study Completion: 2024-05-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aromatherapy	STILL QuickTAB Medipack blended scent aromatherapy, manufactured by Soothing Scents	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.

Primary Outcome Measures

Name	Time	Method
Effect of aromatherapy on post patient anxiety scores	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)

Secondary Outcome Measures

Name	Time	Method
Effect of aromatherapy on post patient port pain scores	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.

Trial Locations

Locations (1)

Stanford University, School of Medicine; 🇺🇸 Stanford, California, United States