The Effects of Aromatherapy on the Incidence and Severity of Acute Pain
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|ClinicalTrials.gov Identifier: NCT03122574|
Recruitment Status : Completed
First Posted : April 21, 2017
Last Update Posted : April 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Venipuncture||Other: Lavender Aromatherapy Other: Jojoba Aromatherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Feasibility Study of the Effects of Aromatherapy on the Incidence and Severity of Acute Pain in Pediatric Patients|
|Actual Study Start Date :||November 2015|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Pure (100%) lavender aromatherapy
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.
Placebo Comparator: Placebo Control
Pure (100%) jojoba aromatherapy
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.
No Intervention: Standard of care Control
No aromatherapy control group
- 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. [ Time Frame: Minute 10 ]Adverse event: defined as verbalization of headache, nausea, or dislike of fragrance.
- Physiological-heart rate [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122574
|United States, District of Columbia|
|Children's National Health System|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Katherine B Curtin, MA||Children's Research Institute|