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The Effects of Aromatherapy on the Incidence and Severity of Acute Pain

Primary Purpose

Venipuncture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lavender Aromatherapy
Jojoba Aromatherapy
Sponsored by
Children's National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venipuncture focused on measuring aromatherapy, pediatric, venipuncture, lavender, pain management

Eligibility Criteria

7 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Children's National Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Treatment

Placebo Control

Standard of care Control

Arm Description

Pure (100%) lavender aromatherapy

Pure (100%) jojoba aromatherapy

No aromatherapy control group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Physiological-heart rate
Heart rate (raw score) as measured using a NONIN Onyx finger cuff. It took approximately 10 seconds to record. Heart rate was measured (1) two-minutes prior to venipuncture, (2) during venipuncture, and (3) two minutes post-venipuncture, covering in total a 4 minute time span.
Psychological- Visual Analogue Scale (VAS) for pain
The VAS for pain is a self-report measure that assesses subjective patient pain on a scale from 0-10. It was administered at the end of the 10 minute study and took approximately one minute to administer.
Psychological- Hospital Fears Rating Scale (HFRS)
The Hospital Fears Rating Scale is a measure of subjective self-report patient anxiety. Scores range from 1-5.It was administered at minute one and again at minute 10 of the study.

Full Information

First Posted
April 3, 2017
Last Updated
April 17, 2017
Sponsor
Children's National Research Institute
Collaborators
American University
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1. Study Identification

Unique Protocol Identification Number
NCT03122574
Brief Title
The Effects of Aromatherapy on the Incidence and Severity of Acute Pain
Official Title
A Feasibility Study of the Effects of Aromatherapy on the Incidence and Severity of Acute Pain in Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's National Research Institute
Collaborators
American University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venipuncture
Keywords
aromatherapy, pediatric, venipuncture, lavender, pain management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Pure (100%) lavender aromatherapy
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
Pure (100%) jojoba aromatherapy
Arm Title
Standard of care Control
Arm Type
No Intervention
Arm Description
No aromatherapy control group
Intervention Type
Other
Intervention Name(s)
Lavender Aromatherapy
Intervention Description
100% pure lavender aromatherapy was administered using person essential oil diffusor sachets, consisting of three drops of oil on a surgical sponge covered in a sealed plastic packet.
Intervention Type
Other
Intervention Name(s)
Jojoba Aromatherapy
Intervention Description
100% pure jojoba aromatherapy was administered using person essential oil diffusor sachets, consisting of three drops of oil on a surgical sponge covered in a sealed plastic packet. This colorless, odorless oil was used as a placebo comparator.
Primary Outcome Measure Information:
Title
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.
Description
Adverse event: defined as verbalization of headache, nausea, or dislike of fragrance.
Time Frame
Minute 10
Secondary Outcome Measure Information:
Title
Physiological-heart rate
Description
Heart rate (raw score) as measured using a NONIN Onyx finger cuff. It took approximately 10 seconds to record. Heart rate was measured (1) two-minutes prior to venipuncture, (2) during venipuncture, and (3) two minutes post-venipuncture, covering in total a 4 minute time span.
Time Frame
Minute 3, Minute 5, Minute 7
Title
Psychological- Visual Analogue Scale (VAS) for pain
Description
The VAS for pain is a self-report measure that assesses subjective patient pain on a scale from 0-10. It was administered at the end of the 10 minute study and took approximately one minute to administer.
Time Frame
Minute 10
Title
Psychological- Hospital Fears Rating Scale (HFRS)
Description
The Hospital Fears Rating Scale is a measure of subjective self-report patient anxiety. Scores range from 1-5.It was administered at minute one and again at minute 10 of the study.
Time Frame
Minute 1, Minute 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine B Curtin, MA
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Health System
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Aromatherapy on the Incidence and Severity of Acute Pain

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