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

NCT03122574 | Completed

• 1 other identifier: Pro0006362
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Venipuncture

Keywords

aromatherapy; pediatric; venipuncture; lavender; pain management

Outcome Measures

Primary Outcomes (1)

• 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.

  Minute 10

Secondary Outcomes (3)

• 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 Arms (3)

Treatment

EXPERIMENTAL

Pure (100%) lavender aromatherapy

Other: Lavender Aromatherapy

Placebo Control

PLACEBO COMPARATOR

Pure (100%) jojoba aromatherapy

Other: Jojoba Aromatherapy

Standard of care Control

NO INTERVENTION

No aromatherapy control group

Interventions

Lavender Aromatherapy OTHER

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.

Treatment

Jojoba Aromatherapy OTHER

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.

Placebo Control

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's National Research Institute: lead
• American University: collaborator

Study Sites (1)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katherine B Curtin, MA

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Coordinator

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 21, 2017
• Study Start: November 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)