Pain PerceptionNCT04396444
Lavender Aromasticks for Pain Control
A study testing Aromastick in people with Pain Perception and Patient Satisfaction, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of this randomized pilot study is to collect preliminary data on the impacts of lavender essential oil aromatherapy on the patient-reported quality of pain management provided for the vascular surgery patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Perception, Patient Satisfaction
- What is being tested?
- Aromastick
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 31 Oct 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 18 and over admitted to the vascular surgery service line on the Heart and Vascular Progressive Care Unit (HVPCU)
- Not cognitively impaired
- Able to perform teach-back of the education regarding safe use of the aromastick
- Able to demonstrate use of the Numeric Pain Rating Scale (NPRS), as evidenced by their ability to answer the initial NPRS question on the Adult Admission II Form used to admit all patients to the hospital
- English is the primary language, as identified by the Adult Admission II Form
Who cannot join
- Subjects who are unable to consent themselves
- Subjects who cannot provide teach-back on the safe use of the aromastick
- Subjects unable to use the NPRS to rate their pain
- Research team member and/or bedside nurse assess that subject has a cognitive deficit that would prohibit safe use of the aromastick
- Subjects on suicide precautions
- Pregnant subjects
Show all 10Show fewer
- Prisoners
- Individuals under age 18
- Subjects with a current plan to use personal aromatherapy devices during their inpatient stay
- Subjects with known lavender allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Lavender Aromasticks as an Option for Pain Control in the Vascular Surgery Population
The purpose of this randomized pilot study is to collect preliminary data on the impacts of lavender essential oil aromatherapy on the patient-reported quality of pain management provided for the vascular surgery patient population. The investigators hypothesize that individuals who use a lavender aromastick as a part of their pain management plan will report improved perceptions of the quality of their pain management as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R).
Subjects will be randomized to the control (empty aromastick) and intervention group (aromastick infused with lavender oil), and will use this device as an addition to their pain management plan.
Additionally, this pilot study will allow the researchers to evaluate the feasibility of a larger randomized control trial, assess the validity of the survey tool, and collect feedback from patients on the acceptability of the aromatherapy intervention as a complementary therapy during their hospital stay.
- Conditions
- Pain Perception, Patient Satisfaction
- Being tested
- Aromastick
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromastickCombination product
Vascular surgery patients will be randomized to either the intervention group and receive a lavender infused aromastick to use as an adjunct to their inpatient pain management plan, or to the control group, given a blank aromastick. Subjects will be blinded to their group.
| Study group | Role | What they receive |
|---|---|---|
| Lavender Aromastick Group | Experimental | The aromastick is a plastic tube, similar in size to a lipstick. A study team member will prepare the aromastick by infusing ten drops of lavender essential oil onto a blank cotton wick inside the tube and sealing the cap. Receives: Combination Product: Aromastick |
| Blank Aromastick Group | Placebo comparator | A study team member will prepare the blank aromastick by placing a blank cotton wick inside the aromastick tube and sealing the cap. Receives: Combination Product: Aromastick |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoints for this study are patients' self-reported evaluations of the quality of pain management provided during their hospital stay.
Measured using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) survey tool. The APS-POQ-R has 18 primary questions with continuous rating scales from 0 - 10 or from 0% - 100%. This study, with permission from the original authors, uses a modified survey, with 10 questions evaluating the subject's pain levels and degree to which pain interferes with various aspects of their quality of life. In these questions, higher numbers indicate higher levels of pain and distress. Four additional Likert style questions evaluate subjects' satisfaction with pain management, with higher numbers indicating higher levels of satisfaction.
Measured: Measured on day 6 of hospital stay or day of discharge; whichever is sooner
Secondary outcomes (1)
Subjects' evaluation of the aromastick
Survey questions will also be asked about use of the aromastick to evaluate acceptability of the intervention device. These are yes/no questions, and questions measuring the frequency of device use.
Measured: Measured on day 6 of hospital stay or day of discharge; whichever is sooner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Aug 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain PerceptionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- dōTERRA International
- Responsible party
- Principal investigator, Rebecca Hornberger, Milton S. Hershey Medical Center
- Investigators
- Rebecca Hornberger, MSN, Principal investigator, Penn State Health Milton S Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396444
- Sponsor's protocol ID
- STUDY00011852
- Status last verified
- Oct 2022
- First submitted
- 15 May 2020
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gordon DB, Polomano RC, Pellino TA, Turk DC, McCracken LM, Sherwood G, Paice JA, Wallace MS, Strassels SA, Farrar JT. Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) for quality improvement of pain management in hospitalized adults: preliminary psychometric evaluation. J Pain. 2010 Nov;11(11):1172-86. doi: 10.1016/j.jpain.2010.02.012. Epub 2010 Apr 18.
PubMed 20400379
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lavender Aromasticks as an Option for Pain Control in the Vascular Surgery Population
- ClinicalTrials.gov ID
- NCT04396444
- Acronym / sponsor ID
- STUDY00011852
- Conditions
- Pain Perception, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- dōTERRA International
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 20 May 2020 (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.
The purpose of this randomized pilot study is to collect preliminary data on the impacts of lavender essential oil aromatherapy on the patient-reported quality of pain management provided for the vascular surgery patient population. The investigators hypothesize that individuals who use a lavender aromastick as a part of their pain management plan will report improved perceptions of the quality of their pain management as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R).
Subjects will be randomized to the control (empty aromastick) and intervention group (aromastick infused with lavender oil), and will use this device as an addition to their pain management plan.
Additionally, this pilot study will allow the researchers to evaluate the feasibility of a larger randomized control trial, assess the validity of the survey tool, and collect feedback from patients on the acceptability of the aromatherapy intervention as a complementary therapy during their hospital stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lavender Aromastick Group | Experimental | Combination Product: AromastickThe aromastick is a plastic tube, similar in size to a lipstick. A study team member will prepare the aromastick by infusing ten drops of lavender essential oil onto a blank cotton wick inside the tube and sealing the cap. |
| Blank Aromastick Group | Placebo comparator | Combination Product: AromastickA study team member will prepare the blank aromastick by placing a blank cotton wick inside the aromastick tube and sealing the cap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects 18 and over admitted to the vascular surgery service line on the Heart and Vascular Progressive Care Unit (HVPCU)
- Not cognitively impaired
- Able to perform teach-back of the education regarding safe use of the aromastick
- Able to demonstrate use of the Numeric Pain Rating Scale (NPRS), as evidenced by their ability to answer the initial NPRS question on the Adult Admission II Form used to admit all patients to the hospital
- English is the primary language, as identified by the Adult Admission II Form
Key exclusion criteria (10 listed)
- Subjects who are unable to consent themselves
- Subjects who cannot provide teach-back on the safe use of the aromastick
- Subjects unable to use the NPRS to rate their pain
- Research team member and/or bedside nurse assess that subject has a cognitive deficit that would prohibit safe use of the aromastick
- Subjects on suicide precautions
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 |
|---|---|---|
| AromastickVascular surgery patients will be randomized to either the intervention group and receive a lavender infused aromastick to use as an adjunct to their inpatient pain management plan, or to the control group, given a blank aromastick. Subjects will be blinded to their group. | Combination product | Blank Aromastick Group, Lavender Aromastick Group |
Primary outcome
The primary endpoints for this study are patients' self-reported evaluations of the quality of pain management provided during their hospital stay.
Time frame: Measured on day 6 of hospital stay or day of discharge; whichever is sooner
Measured using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) survey tool. The APS-POQ-R has 18 primary questions with continuous rating scales from 0 - 10 or from 0% - 100%. This study, with permission from the original authors, uses a modified survey, with 10 questions evaluating the subject's pain levels and degree to which pain interferes with various aspects of their quality of life. In these questions, higher numbers indicate higher levels of pain and distress. Four additional Likert style questions evaluate subjects' satisfaction with pain management, with higher numbers indicating higher levels of satisfaction.
1 secondary outcome
Subjects' evaluation of the aromastick
Time frame: Measured on day 6 of hospital stay or day of discharge; whichever is sooner
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 26 Oct 2022.
- Background: PubMed 20400379Gordon DB, Polomano RC, Pellino TA, Turk DC, McCracken LM, Sherwood G, Paice JA, Wallace MS, Strassels SA, Farrar JT. Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) for quality improvement of pain management in hospitalized adults: preliminary psychometric evaluation. J Pain. 2010 Nov;11(11):1172-86. doi: 10.1016/j.jpain.2010.02.012. Epub 2010 Apr 18.
- Individual participant dataSharing planned: No
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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.
Rebecca Hornberger, MSN principal investigator
Penn State Health Milton S Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromastick in people with Pain Perception and Patient Satisfaction, run by Milton S. Hershey Medical Center 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 5 inclusion and 10 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 26 Oct 2022. 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?
The primary endpoints for this study are patients' self-reported evaluations of the quality of pain management provided during their hospital stay. (time frame: Measured on day 6 of hospital stay or day of discharge; whichever is sooner). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04396444, which also lists 1 linked publication.
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 26 Oct 2022.