Aromatherapy Randomization of Pain Management in Adults (AROMA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03377088|
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : April 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Back Pain Back Pain, Low Sciatica||Other: Rose oil Other: Almond Oil||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Aromatherapy for Management of Back Pain in the Emergency Department|
|Actual Study Start Date :||December 11, 2017|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||May 17, 2019|
Placebo Comparator: Almond Oil
Patients will be given Almond Oil for inhalation on cotton balls as a control. Almond Oil has been shown to act as a placebo when compared to our variable, Rosa Damascena oil. To ensure blinding, this arm will act to always deliver a scent to a patient, blinding them to whether they are receiving a known aromatherapy or a common scent.
Other: Almond Oil
Almond Oil has been shown in limited studies to act as a placebo for pain control when compared to Rose Oil. This subtly sweet oil will be used to ensure the patient always receives a smell, and maintains blinding.
Other Name: Sweet almond oil
Experimental: Rose Oil
Patients will be given Rosa Damascena oil on cottons balls as a variable. This oil has been shown to significantly lower acute pain levels on the visual analog pain scale when compared to placebo of distilled water or Almond Oil.
Other: Rose oil
Rose oil will be given as the intervention in this study, an over-the-counter agent that can be commonly found in retail stores. It will be delivered as 2 drops 50% rose oil in water on a cotton ball within 20 cm of the patient's face for 30 minutes.
Other Name: Rosa Damascena (Damask Rose) essential oil
- Acute Pain Reduction [ Time Frame: 30 minutes, immediately after treatment ]A 100 mm visual analog scale (VAS) for pain will be administered prior to and after treatment to assess for clinically significant pain control
- Patient Satisfaction [ Time Frame: 30 minutes (immediately after) treatment ]Patients will be asked after treatment how satisfied they are with their treatment on a 5 point likert scale
- Patient Pain Toleration [ Time Frame: 30 minutes (immediately after) treatment ]Patients will be asked to subjectively report changes in their pain after completing a VAS pain scale on a 5 point likert scale
- Patient Arm Belief [ Time Frame: 30 minutes (immediately after treatment) ]Patients will be asked if they think the agent they received was in fact the experimental scent or not, and whether they would consider using it again for future pain control.
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): NCT03377088
|Contact: Stephen G Meigher, BAemail@example.com|
|Contact: Adam J Singer, MDfirstname.lastname@example.org|
|United States, New York|
|Stony Brook University Hospital Emergency Department||Recruiting|
|Stony Brook, New York, United States, 11794|
|Contact: Stephen G Meigher, BA 518-937-3489 email@example.com|
|Contact: Adam J Singer, MD 6314447857 firstname.lastname@example.org|