Spine Injuries and DisordersNCT04156009
Lavender Aromatherapy Spine Procedure Study
A study testing Activated Lavender Elequil aromatabs® (#372) and Unactivated Lavender Elequil aromatabs® (#372) in people with Spine Injuries and Disorders and Pain, Back, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spine Injuries and Disorders, Pain, Back
- What is being tested?
- Activated Lavender Elequil aromatabs® (#372) and Unactivated Lavender Elequil aromatabs® (#372)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2020to 18 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between 18-85 years old
- Scheduled for one of the following procedures on the day of consent:
- Epidural steroid injection (ESI)
- Medial branch block (MBB)
- Radiofrequency ablation (RFA)
- Able to provide informed consent
Who cannot join
- History of anxiety disorder
- Currently on anxiolytic therapy
- Poor sense of smell
- Allergy/aversion to aromatherapy
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aromatherapy for Procedural Anxiety in Pain Management and Interventional Spine Procedures
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.
- Conditions
- Spine Injuries and Disorders, Pain, Back
- Being tested
- Activated Lavender Elequil aromatabs® (#372), Unactivated Lavender Elequil aromatabs® (#372)
- Keywords
- aromatherapy, lavender, anxiety, spine intervention
- Medical subject headings
- Disease, Back Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated Lavender Elequil aromatabs® (#372)Other
Activated Lavender aromatherapy tablets wrapped in tape
Unactivated Lavender Elequil aromatabs® (#372)Other
Unactivated Lavender aromatherapy tablets wrapped in tape
| Study group | Role | What they receive |
|---|---|---|
| Treatment (+aromatherapy) group | Experimental | Not described Receives: Other: Activated Lavender Elequil aromatabs® (#372) |
| Control (-aromatherapy) group | Sham comparator | Not described Receives: Other: Unactivated Lavender Elequil aromatabs® (#372) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Subjects' Anxiety State as measured by the State Trait Anxiety Inventory (STAI-6)
The STAI-6 is a six-item assessment of state anxiety. Each item is assessed on a four-point Likert scale. Scores on the STAI-6 range from 6-24, with a higher score indicating greater state anxiety.
Measured: Administered within 30 minutes before and 30 minutes after intervention
Secondary outcomes (2)
Number of Vasovagal Events during Standard of Care Spine Procedure
All vasovagal events that occur during the standard of care spine procedure will be recorded and reported
Measured: Assessed within 30 minutes following the standard of care spine procedure
Number of Aborted Standard of Care Spine Procedures
Measured: Assessed within 30 minutes following standard of care spine procedure completion or abortion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start29 Jan 2020
- Primary completion18 Nov 2020
- Study completion18 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine Injuries and DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaspal R Singh, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156009
- Sponsor's protocol ID
- 19-06020284
- Status last verified
- Jan 2021
- First submitted
- 1 Nov 2019
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy for Procedural Anxiety in Pain Management and Interventional Spine Procedures
- ClinicalTrials.gov ID
- NCT04156009
- Acronym / sponsor ID
- 19-06020284
- Conditions
- Spine Injuries and Disorders, Pain, Back
- Keywords
- aromatherapy, lavender, anxiety, spine intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (+aromatherapy) group | Experimental | Other: Activated Lavender Elequil aromatabs® (#372) |
| Control (-aromatherapy) group | Sham comparator | Other: Unactivated Lavender Elequil aromatabs® (#372) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females between 18-85 years old
- Scheduled for one of the following procedures on the day of consent:
- Able to provide informed consent
Key exclusion criteria (5 listed)
- History of anxiety disorder
- Currently on anxiolytic therapy
- Poor sense of smell
- Allergy/aversion to aromatherapy
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activated Lavender Elequil aromatabs® (#372)Activated Lavender aromatherapy tablets wrapped in tape | Other | Treatment (+aromatherapy) group |
| Unactivated Lavender Elequil aromatabs® (#372)Unactivated Lavender aromatherapy tablets wrapped in tape | Other | Control (-aromatherapy) group |
Primary outcome
Change in Subjects' Anxiety State as measured by the State Trait Anxiety Inventory (STAI-6)
Time frame: Administered within 30 minutes before and 30 minutes after intervention
The STAI-6 is a six-item assessment of state anxiety. Each item is assessed on a four-point Likert scale. Scores on the STAI-6 range from 6-24, with a higher score indicating greater state anxiety.
2 secondary outcomes
Number of Vasovagal Events during Standard of Care Spine Procedure
Time frame: Assessed within 30 minutes following the standard of care spine procedure
Number of Aborted Standard of Care Spine Procedures
Time frame: Assessed within 30 minutes following standard of care spine procedure completion or abortion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaspal R Singh, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activated Lavender Elequil aromatabs® (#372) and Unactivated Lavender Elequil aromatabs® (#372) in people with Spine Injuries and Disorders and Pain, Back, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Subjects' Anxiety State as measured by the State Trait Anxiety Inventory (STAI-6) (time frame: Administered within 30 minutes before and 30 minutes after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.