Lavender Aromatherapy Spine Procedure Study

NCT ID: NCT04156009

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-29

Study Completion Date

2020-11-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spine Injuries and Disorders Pain, Back

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
For the treatment group, the aromatherapy tablets will be activated for max aromatherapy. For the control group, the tablets will not be activated and will be devoid of scent. For both groups, the tablet will be wrapped in masking tape to maintain the blind for subjects.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment (+aromatherapy) group

Group Type EXPERIMENTAL

Activated Lavender Elequil aromatabs® (#372)

Intervention Type OTHER

Activated Lavender aromatherapy tablets wrapped in tape

Control (-aromatherapy) group

Group Type SHAM_COMPARATOR

Unactivated Lavender Elequil aromatabs® (#372)

Intervention Type OTHER

Unactivated Lavender aromatherapy tablets wrapped in tape

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Activated Lavender Elequil aromatabs® (#372)

Activated Lavender aromatherapy tablets wrapped in tape

Intervention Type OTHER

Unactivated Lavender Elequil aromatabs® (#372)

Unactivated Lavender aromatherapy tablets wrapped in tape

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jaspal R Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Weill Cornell Medicine

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19-06020284

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Essential Oils for Electrocautery
NCT04260867 ACTIVE_NOT_RECRUITING NA