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Clinical Trials/NCT03122574
NCT03122574
Completed
Not Applicable

A Feasibility Study of the Effects of Aromatherapy on the Incidence and Severity of Acute Pain in Pediatric Patients

Children's National Research Institute1 site in 1 country21 target enrollmentNovember 2015
ConditionsVenipuncture

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Venipuncture
Sponsor
Children's National Research Institute
Enrollment
21
Locations
1
Primary Endpoint
Percentage of participants who complete the intervention in the ten-minute time frame without an adverse event, assessed by stop-watch recording and RN monitoring.
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this research was to estimate feasibility of an aromatherapy pain management intervention to reduce pain and distress caused by venipunctures in a pediatric population. The feasibility of the use of aromatherapy essential oil lavandula angustifolia for pain management intervention (Treatment Group) was compared to placebo aromatherapy with jojoba oil (Placebo Control Group) and to the current standard of care, which is no oil during a venipuncture (Standard of Care Control Group). Primary measured outcomes were assessed using a double-blind randomized design. The physiological measure of heart rate was taken over the course of four minutes at three different intervals to note the pattern of change that occurs during anticipatory anxiety resulting from the impending procedure, the procedural pain experienced during the venipuncture, and the residual fear common after completion of the venipuncture procedure. The Visual Analogue Scale (VAS) for pain and the Hospital Fears Rating Scale (HFRS) were administered to measure subjective pain and anxiety. Participants (N=21) were recruited from the Laboratory Medicine Unit of Children's National Health System. Feasibility was estimated based on the ability to inhale the full dose of oil without adverse effects and and ability to inhale the full dose within the ten-minute time frame. This study analyzed the effect of the aromatherapy pain management intervention, lavandula angustifolia aromatherapy, on the stress response of a pediatric population through observation of physiological and psychological indicators of pain and distress, in order to learn more about the pain and anxiety experienced during venipuncture and the use of aromatherapy to decrease pain and anxiety during venipuncture.

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
February 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Children's National Research Institute
Responsible Party
Principal Investigator
Principal Investigator

Katherine Curtin

Clinical Research Coordinator

Children's National Research Institute

Eligibility Criteria

Inclusion Criteria

  • Scheduled for venipuncture
  • English speaking
  • Parental written consent
  • Child's verbal assent

Exclusion Criteria

  • Essential oil allergy
  • Peanut allergy (nut oils processed by manufacturer)
  • Medical hypersensitivity to smell
  • Asthma triggered by foreign scent
  • Frequent venipuncture (5 or more a year)
  • Current pain or anxiety medication

Outcomes

Primary Outcomes

Percentage of participants who complete the intervention in the ten-minute time frame without an adverse event, assessed by stop-watch recording and RN monitoring.

Time Frame: Minute 10

Adverse event: defined as verbalization of headache, nausea, or dislike of fragrance.

Secondary Outcomes

  • Physiological-heart rate(Minute 3, Minute 5, Minute 7)
  • Psychological- Visual Analogue Scale (VAS) for pain(Minute 10)
  • Psychological- Hospital Fears Rating Scale (HFRS)(Minute 1, Minute 10)

Study Sites (1)

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