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

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05696899
Collaborator
(none)
115
1
2
6
19.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: STILL QuickTAB Medipack blended scent aromatherapy, manufactured by Soothing Scents
N/A

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
Anticipated Enrollment :
115 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Determining the Efficacy of Essential Oil Aromatherapy in Children Undergoing Port Access
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aromatherapy

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

No Intervention: Control Group

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.

Outcome Measures

Primary Outcome Measures

  1. Effect of aromatherapy on post patient anxiety scores [5 minutes]

    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)

  2. Effect of aromatherapy on post patient pain scale [5 minutes]

    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)

Secondary Outcome Measures

  1. Effect of aromatherapy on pre and post patient port pain scores [up to 7 minutes]

    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.

Other Outcome Measures

  1. Aromatherapy effect according to age [up to 7 minutes]

    To compare pre and post pain and anxiety scores between the three age groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 18 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University, School of Medicine Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

  • Study Director: Annette Nasr, PhD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stanford University
ClinicalTrials.gov Identifier:
NCT05696899
Other Study ID Numbers:
  • IRB-68138
First Posted:
Jan 25, 2023
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stanford University

Study Results

No Results Posted as of Jan 25, 2023