Anxiety Related to Pain Related to an Intraarticular InjectionNCT05832983
Aromatherapy and Anxiety Study
A study testing Guided Meditation and Aromatherapy in people with Anxiety Related to Pain Related to an Intraarticular Injection and Pain Related to an Intraarticular Injection, run by NYU Langone Health at 1 site in United States.
Trial summary
While intra-articular injections can alleviate pain in orthopedic patients, this can be an anxiety-provoking experience. Adult patients scheduled to receive an injection at the study location will be randomly assigned to one of three groups. The control group (C) will receive the current standard of nursing care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Related to Pain Related to an Intraarticular Injection, Pain Related to an Intraarticular Injection
- What is being tested?
- Guided Meditation and Aromatherapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jul 2023to 21 Feb 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient has an in-office appointment at the NYU Langone Ambulatory Care-23rd Street location with either the Ortho A \& B (primarily those patients who may be seeking knee or hip replacement surgery), Hand, or Primary Sport clinics.
- Patient has an order for an intra-articular injection (as determined by clinic MD) and has consented to receiving that treatment.
- Patient is English speaking.
Who cannot join
- Patient has a cognitive or physical disability that would interfere with their ability to complete the study's pre and post assessments with RN.
- Patient is found on the pre-injection assessment form to have an intolerance or allergy to lavender, sandalwood, or strong scents in general.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Aromatherapy on Situational Anxiety in Adults Receiving Intra-Articular Injections in the Ambulatory Clinic Setting
While intra-articular injections can alleviate pain in orthopedic patients, this can be an anxiety-provoking experience. Adult patients scheduled to receive an injection at the study location will be randomly assigned to one of three groups. The control group (C) will receive the current standard of nursing care. The first experimental group (A) will receive a guided meditation prior to receiving the injection. The second experimental group (B) will receive an Elequil Aromatab and the same guided meditation prior to receiving the injection.
Read the detailed description
The objective of the study is to measure the difference in anxiety levels of adult orthopedic patients in need of intra-articular injections who receive a guided meditation only prior to their injection, compared to those who receive a guided meditation and an aromatherapy Elequil Aromatab prior to injection, as well as compared with those who receive the usual standard of care
- Conditions
- Anxiety Related to Pain Related to an Intraarticular Injection, Pain Related to an Intraarticular Injection
- Being tested
- Guided Meditation, Aromatherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided MeditationBehavioural
In private exam room, the study registered nurse (RN) will read a prepared two minute guided meditation to patient.
AromatherapyOther
Also called Elequil Aromatab
In private exam room, study RN will first affix an Elequil Aromatab to patient's clothing on either their upper arm or chest (whichever the patient prefers and/or as clothing allows).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in the control arm will receive the current standard of nursing care for treating anxiety prior to receiving the intra-articular injection (emotional support, distraction, and/or therapeutic touch as necessary). |
| Experimental Group A | Experimental | Participants in Group A will receive a guided meditation prior to receiving the intra-articular injection. Receives: Behavioral: Guided Meditation |
| Experimental Group B | Experimental | Participants in Group B will receive an Elequil Aromatab and the same guided meditation delivered to Group A prior to receiving the intra-articular injection. Receives: Behavioral: Guided Meditation; Other: Aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short-Version Spielberger State-Trait Anxiety Inventory (SSTAI) Score
The Short-Version SSTAI is a 10-item self-assessment of anxiety, with 5 items assessing states of anxiety and 5 items assessing traits of anxiety. Each item is scored on a Likert scale ranging from 1 to 4, where (1 = not at all) and (4 = very much so). The total score is the sum of responses and ranges from 10-40; lower scores indicate lower levels of anxiety. A decrease in scores indicates anxiety decreased during the observational period.
Measured: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
Change in Pain Score
On a scale of 0 to 10 (0 = no pain, 10 = the worst pain imaginable), participants rank their pain prior to the injection and after the injection. The total score ranges from 0-10, with higher scores indicating greater pain. A decrease in score indicates pain decreased during the observational period.
Measured: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
Change in Blood Pressure
Participants will have their blood pressure (systolic/diastolic - mmHg) taken before and after the injection.
Measured: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
Change in Heart Rate
Participants will have their heart rate (beats per minute) measured before and after the injection.
Measured: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start4 Jul 2023
- Primary completion21 Feb 2024
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Related to Pain Related to an Intraarticular InjectionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Withall, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832983
- Sponsor's protocol ID
- 23-00170
- Status last verified
- Mar 2025
- First submitted
- 17 Apr 2023
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data to be used for only this study.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy on Situational Anxiety in Adults Receiving Intra-Articular Injections in the Ambulatory Clinic Setting
- ClinicalTrials.gov ID
- NCT05832983
- Acronym / sponsor ID
- 23-00170
- Conditions
- Anxiety Related to Pain Related to an Intraarticular Injection, Pain Related to an Intraarticular Injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 27 Apr 2023 (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.
While intra-articular injections can alleviate pain in orthopedic patients, this can be an anxiety-provoking experience. Adult patients scheduled to receive an injection at the study location will be randomly assigned to one of three groups. The control group (C) will receive the current standard of nursing care. The first experimental group (A) will receive a guided meditation prior to receiving the injection. The second experimental group (B) will receive an Elequil Aromatab and the same guided meditation prior to receiving the injection.
Detailed description
The objective of the study is to measure the difference in anxiety levels of adult orthopedic patients in need of intra-articular injections who receive a guided meditation only prior to their injection, compared to those who receive a guided meditation and an aromatherapy Elequil Aromatab prior to injection, as well as compared with those who receive the usual standard of care
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in the control arm will receive the current standard of nursing care for treating anxiety prior to receiving the intra-articular injection (emotional support, distraction, and/or therapeutic touch as necessary). |
| Experimental Group A | Experimental | Behavioral: Guided MeditationParticipants in Group A will receive a guided meditation prior to receiving the intra-articular injection. |
| Experimental Group B | Experimental | Behavioral: Guided Meditation, Other: AromatherapyParticipants in Group B will receive an Elequil Aromatab and the same guided meditation delivered to Group A prior to receiving the intra-articular injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has an in-office appointment at the NYU Langone Ambulatory Care-23rd Street location with either the Ortho A \& B (primarily those patients who may be seeking knee or hip replacement surgery), Hand, or Primary Sport clinics.
- Patient has an order for an intra-articular injection (as determined by clinic MD) and has consented to receiving that treatment.
- Patient is English speaking.
Key exclusion criteria (2 listed)
- Patient has a cognitive or physical disability that would interfere with their ability to complete the study's pre and post assessments with RN.
- Patient is found on the pre-injection assessment form to have an intolerance or allergy to lavender, sandalwood, or strong scents in general.
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 |
|---|---|---|
| Guided MeditationIn private exam room, the study registered nurse (RN) will read a prepared two minute guided meditation to patient. | Behavioural | Experimental Group A, Experimental Group B |
| AromatherapyAlso: Elequil AromatabIn private exam room, study RN will first affix an Elequil Aromatab to patient's clothing on either their upper arm or chest (whichever the patient prefers and/or as clothing allows). | Other | Experimental Group B |
Primary outcome
Change in Short-Version Spielberger State-Trait Anxiety Inventory (SSTAI) Score
Time frame: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
The Short-Version SSTAI is a 10-item self-assessment of anxiety, with 5 items assessing states of anxiety and 5 items assessing traits of anxiety. Each item is scored on a Likert scale ranging from 1 to 4, where (1 = not at all) and (4 = very much so). The total score is the sum of responses and ranges from 10-40; lower scores indicate lower levels of anxiety. A decrease in scores indicates anxiety decreased during the observational period.
Change in Pain Score
Time frame: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
On a scale of 0 to 10 (0 = no pain, 10 = the worst pain imaginable), participants rank their pain prior to the injection and after the injection. The total score ranges from 0-10, with higher scores indicating greater pain. A decrease in score indicates pain decreased during the observational period.
Change in Blood Pressure
Time frame: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
Participants will have their blood pressure (systolic/diastolic - mmHg) taken before and after the injection.
Change in Heart Rate
Time frame: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
Participants will have their heart rate (beats per minute) measured before and after the injection.
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 25 Mar 2025.
- Individual participant dataSharing planned: No. Data to be used for only this study.
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.
Jennifer Withall, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Meditation and Aromatherapy in people with Anxiety Related to Pain Related to an Intraarticular Injection and Pain Related to an Intraarticular Injection, run by NYU Langone Health 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 3 inclusion and 2 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 25 Mar 2025. 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. 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 Short-Version Spielberger State-Trait Anxiety Inventory (SSTAI) Score (time frame: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)). The study lists 4 primary outcomes in all. 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 25 Mar 2025.