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Clinical Trials/NCT05696899
NCT05696899CompletedNot Applicable

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

Stanford University1 site in 1 country23 target enrollmentStarted: December 5, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
23
Locations
1
Primary Endpoint
Effect of aromatherapy on post patient anxiety scores

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
4 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Aromatherapy

Experimental

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.

Intervention: STILL QuickTAB Medipack blended scent aromatherapy, manufactured by Soothing Scents (Other)

Control Group

No Intervention

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.

Outcomes

Primary Outcomes

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

  • Effect of aromatherapy on post patient port pain scores(up to 7 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Annette Nasr

Nurse Scientist Nursing Research and Evidence-Based Practice

Stanford University

Study Sites (1)

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