Venipuncture
Conditions
Keywords
aromatherapy, pediatric, venipuncture, lavender, pain management
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.
Interventions
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.
OTHERJojoba 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.
Sponsors
American University
Children's National Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Minute 10 | Adverse event: defined as verbalization of headache, nausea, or dislike of fragrance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physiological-heart rate | Minute 3, Minute 5, Minute 7 | 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 | Minute 10 | 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) | Minute 1, Minute 10 | 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. |
Countries
United States
Outcome results
None listed