Determining the Efficacy of Essential Oil Aromatherapy in Children Undergoing Port Access
NCT ID: NCT05696899
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2023-12-05
2024-05-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Scheduled for port access with or without lab draw
3. Oncology, neuro-oncology, and stem cell transplant patients
Exclusion Criteria
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
4 Years
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Annette Nasr
Nurse Scientist Nursing Research and Evidence-Based Practice
Principal Investigators
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Annette Nasr, PhD
Role: STUDY_DIRECTOR
Stanford University
Locations
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Stanford University, School of Medicine
Stanford, California, United States
Countries
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References
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Bikmoradi A, Khaleghverdi M, Seddighi I, Moradkhani S, Soltanian A, Cheraghi F. Effect of inhalation aromatherapy with lavender essence on pain associated with intravenous catheter insertion in preschool children: A quasi-experimental study. Complement Ther Clin Pract. 2017 Aug;28:85-91. doi: 10.1016/j.ctcp.2017.05.008. Epub 2017 May 24.
Ghaderi F, Solhjou N. The effects of lavender aromatherapy on stress and pain perception in children during dental treatment: A randomized clinical trial. Complement Ther Clin Pract. 2020 Aug;40:101182. doi: 10.1016/j.ctcp.2020.101182. Epub 2020 Apr 28.
Kang HJ, Nam ES, Lee Y, Kim M. How Strong is the Evidence for the Anxiolytic Efficacy of Lavender?: Systematic Review and Meta-analysis of Randomized Controlled Trials. Asian Nurs Res (Korean Soc Nurs Sci). 2019 Dec;13(5):295-305. doi: 10.1016/j.anr.2019.11.003. Epub 2019 Nov 16.
Karaman T, Karaman S, Dogru S, Tapar H, Sahin A, Suren M, Arici S, Kaya Z. Evaluating the efficacy of lavender aromatherapy on peripheral venous cannulation pain and anxiety: A prospective, randomized study. Complement Ther Clin Pract. 2016 May;23:64-8. doi: 10.1016/j.ctcp.2016.03.008. Epub 2016 Mar 25.
Kucuk Alemdar D, Yaman Aktas Y. The Use of the Buzzy, Jet Lidokaine, Bubble-blowing and Aromatherapy for Reducing Pediatric Pain, Stress and Fear Associated with Phlebotomy. J Pediatr Nurs. 2019 Mar-Apr;45:e64-e72. doi: 10.1016/j.pedn.2019.01.010. Epub 2019 Jan 30.
Other Identifiers
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PEDSVAR0068
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-68138
Identifier Type: -
Identifier Source: org_study_id