Lavender Aromatherapy Spine Procedure Study

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Pain, Back; Spine Injuries and Disorders

Treatments: Other: Unactivated Lavender Elequil aromatabs® (#372); Other: Activated Lavender Elequil aromatabs® (#372)

Study type: Interventional

Funder types: Other

Identifiers

NCT04156009

19-06020284

Details and patient eligibility

About

Patient anxiety prior to invasive procedures poses a significant barrier to successful treatment if not well-managed. The purpose of this study is to evaluate lavender aromatherapy, a non-sedating alternative, to reduce anxiety prior to interventional spinal procedures.

Enrollment: 109 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females between 18-85 years old

2. Scheduled for one of the following procedures on the day of consent:

   1. Epidural steroid injection (ESI)
   2. Medial branch block (MBB)
   3. Radiofrequency ablation (RFA)

3. Able to provide informed consent

Exclusion criteria

1. History of anxiety disorder
2. Currently on anxiolytic therapy
3. Poor sense of smell
4. Allergy/aversion to aromatherapy
5. Non-English speaking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

109 participants in 2 patient groups

Treatment (+aromatherapy) group

Experimental group

Treatment:

Other: Activated Lavender Elequil aromatabs® (#372)

Control (-aromatherapy) group

Sham Comparator group

Treatment:

Other: Unactivated Lavender Elequil aromatabs® (#372)