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Completed

NCT Number: NCT05696899

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

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.

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Key information

Conditions

Anxiety and Fear Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STILL QuickTAB Medipack blended scent aromatherapy, manufactured by Soothing Scents

Other

A resealable quick-tab dispenser with the 'therapeutic inhaled essential oils' lavender, bergamot, sweet orange, and ylang ylang.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2023
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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