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NCT05696899 | Not yet recruiting | Anxiety and Fear

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

Condition or disease

Anxiety and Fear

Pain

Intervention/treatment

STILL QuickTAB Medipack blended scent aromatherapy, manufactured by Soothing Scents

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 115 participants
Masking : None (Open Label)
Primary Purpose : Supportive Care
Official Title : Determining the Efficacy of Essential Oil Aromatherapy in Children Undergoing Port Access
Actual Study Start Date : March 1, 2023
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : August 30, 2023
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.

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.
Ages Eligible for Study: 4 Years to 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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
Determining the Efficacy of Essential Oil Aromatherapy in Children Undergoing Port Access

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Stanford University, School of Medicine

Stanford, California, United States, 94305