NCT03122574

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Children's National Research Institute · Academic / Other
• Sex: All
• Age: 7 Years – 11 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	Lavender Aromatherapy	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.
OTHER	Jojoba Aromatherapy	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.

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2017-04-21
• Last updated: 2017-04-21

Locations

1 site across 1 country: United States