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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05696899
Enrollment
23
Registered
2023-01-25
Start date
2023-12-05
Completion date
2024-05-30
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety and Fear, Pain

Keywords

Aromatherapy, Port-a-Cath, Pediatric

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.

Interventions

OTHERSTILL 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.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of aromatherapy on post patient anxiety scores5 minutesComparison 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

MeasureTime frameDescription
Effect of aromatherapy on post patient port pain scoresup to 7 minutesComparison 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.

Other

MeasureTime frameDescription
Aromatherapy effect according to ageup to 7 minutesTo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026