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NCT03122574 · ClinicalTrials.gov registry record · NA
The Effects of Aromatherapy on the Incidence and Severity of Acute Pain
A NA study, sponsored by Children's National Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT03122574 is a NA study that has completed, run by Children's National Research Institute. The registered enrollment target is 21 participants.
The verdict
NCT03122574, a NA study, has completed, sponsored by Children's National Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study 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
- OTHER Lavender Aromatherapy
- OTHER Jojoba Aromatherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2015-11 |
| Est. Completion | 2016-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03122574
The ClinicalTrials.gov registry entry for NCT03122574 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's National Research Institute, which has 92 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lavender Aromatherapy is the first listed.
NCT03122574 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03122574 about?
NCT03122574 is a clinical study titled "The Effects of Aromatherapy on the Incidence and Severity of Acute Pain". 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 (Tr...
What is the current status of trial NCT03122574?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2015-11. Estimated completion is 2016-02.
What interventions are being tested in trial NCT03122574?
The interventions under investigation include: Lavender Aromatherapy (OTHER), Jojoba Aromatherapy (OTHER).
Who is sponsoring clinical trial NCT03122574?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
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