Phobia PhlebotomyNCT02764567
Essential Oil Aromatherapy Intervention
A study testing Essential Oil in people with Phobia Phlebotomy, run by HealthEast Care System at 1 site in United States.
Trial summary
Lab sampling for clinical trial participants can be a stressful and painful experience. Most trial participants will have blood drawn for lab samples at multiple study visits. The participants must fast for up to ten hours before the blood sampling, in many cases, and patients often report a painful experience if more… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phobia Phlebotomy
- What is being tested?
- Essential Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Dec 2017
- 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
- Must be at least 18 years of age
- Must be currently participating in a clinical trial at HealthEast
Who cannot join
- Known allergy to any of the oils used for aromatherapy
- Less than age 18
- Declined to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthEast Clinical Trials Office
Saint Paul, Minnesota, 55104
About this study
Official title: Essential Oil Aromatherapy Intervention: Easing the Discomforts of Phlebotomy With Essential Oil Aromatherapy
Lab sampling for clinical trial participants can be a stressful and painful experience. Most trial participants will have blood drawn for lab samples at multiple study visits. The participants must fast for up to ten hours before the blood sampling, in many cases, and patients often report a painful experience if more than one venipuncture occurs. In addition, the number of collection tubes can increase the anxiety level of the patient and the phlebotomist.
This project proposes to evaluate if essential oil aromatherapy results in less pain and /or anxiety when compared to usual care.
Read the detailed description
The process of drawing blood for can be painful and stressful for any patient. Those patients who participate in a clinical trial agree to frequent lab sampling to monitor for effect and safety of the investigational product. The frequency is variable, from several times a day for a participant in the hospital to annually for some trials. Participants have reported anxiety regarding the number of tubes to be drawn, even resulting in near syncope, and pain with the venipuncture process.
The clinical trial nurses at HealthEast have utilized a variety of therapeutic techniques to ease the pain and anxiety experienced by the trial subjects, such as redirection, deep breathing, hand massage and guided imagery. These techniques have not been evaluated for effectiveness in easing pain and anxiety nor have they been compared with no intervention to determine if any intervention was more efficacious in alleviating pain and/or anxiety.
The primary objective of this study is determine if aromatherapy with an essential oil has a higher reported effect in anxiety and pain relief with venipunctures than standard of care (no therapy) among participants in HealthEast Clinical Trials Office studies.
Secondary objectives include comparing the number of venipunctures and blood collection tubes in the treatment arms.
This is a randomized, open label, prospective single site study designed to determine the effect of essential oil aromatherapy compared to usual care on pain and anxiety associated with venipunctures for clinical trial participants in the HealthEast Heart Care Clinic.
- Conditions
- Phobia Phlebotomy
- Being tested
- Essential Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential OilOther
Participants in this arm will be offered one of three essential oils: ginger, lavender or calming
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy | Experimental | The participants randomized to aromatherapy will be offered one of three essential oils, 'applied' to their smell zone via cotton ball that are known to have anti-anxiety effect. These are:
* ginger
* calming
* lavender The participant's choice will be documented in a database. The participant can chose an oil each time (i.e., they are not bound to use only the first choice oil). Pain and anxiety will be measured prior to receiving the essential oils and again after the phlebotomy procedure. Blood pressure and pulse will also be measured post-phlebotomy. Receives: Other: Essential Oil |
| Standard of Care | No intervention | The participants randomized to standard of care will proceed to the outpatient phlebotomy room in the Heart Care Clinic as per usual care. Pain, anxiety, blood pressure and pulse will be assessed pre and post-procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Scores
Measured: At the time of study enrollment and again upon completion at 6 months
Change in Anxiety Scores
Measured: At the time of study enrollment and again upon completion at 6 months
Secondary outcomes (2)
Number of venipunctures needed to collect required sample
Measured: At the time of study completion at 6 months
Number of blood collection tubes required for sample
Measured: At the time of study completion at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phobia PhlebotomyStudies 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
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthEast Care System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beth Jorgeonson, RN, BSN, Principal investigator, HealthEast Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764567
- Sponsor's protocol ID
- HE 16 04 002
- Status last verified
- Feb 2018
- First submitted
- 2 May 2016
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Study results will be shared with the organization and submitted for publication. Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essential Oil Aromatherapy Intervention: Easing the Discomforts of Phlebotomy With Essential Oil Aromatherapy
- ClinicalTrials.gov ID
- NCT02764567
- Acronym / sponsor ID
- HE 16 04 002
- Conditions
- Phobia Phlebotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- HealthEast Care SystemUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 May 2016 (estimated)
- 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.
Lab sampling for clinical trial participants can be a stressful and painful experience. Most trial participants will have blood drawn for lab samples at multiple study visits. The participants must fast for up to ten hours before the blood sampling, in many cases, and patients often report a painful experience if more than one venipuncture occurs. In addition, the number of collection tubes can increase the anxiety level of the patient and the phlebotomist.
This project proposes to evaluate if essential oil aromatherapy results in less pain and /or anxiety when compared to usual care.
Detailed description
The process of drawing blood for can be painful and stressful for any patient. Those patients who participate in a clinical trial agree to frequent lab sampling to monitor for effect and safety of the investigational product. The frequency is variable, from several times a day for a participant in the hospital to annually for some trials. Participants have reported anxiety regarding the number of tubes to be drawn, even resulting in near syncope, and pain with the venipuncture process.
The clinical trial nurses at HealthEast have utilized a variety of therapeutic techniques to ease the pain and anxiety experienced by the trial subjects, such as redirection, deep breathing, hand massage and guided imagery. These techniques have not been evaluated for effectiveness in easing pain and anxiety nor have they been compared with no intervention to determine if any intervention was more efficacious in alleviating pain and/or anxiety.
The primary objective of this study is determine if aromatherapy with an essential oil has a higher reported effect in anxiety and pain relief with venipunctures than standard of care (no therapy) among participants in HealthEast Clinical Trials Office studies.
Secondary objectives include comparing the number of venipunctures and blood collection tubes in the treatment arms.
This is a randomized, open label, prospective single site study designed to determine the effect of essential oil aromatherapy compared to usual care on pain and anxiety associated with venipunctures for clinical trial participants in the HealthEast Heart Care Clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy | Experimental | Other: Essential OilThe participants randomized to aromatherapy will be offered one of three essential oils, 'applied' to their smell zone via cotton ball that are known to have anti-anxiety effect. These are: * ginger * calming * lavender The participant's choice will be documented in a database. The participant can chose an oil each time (i.e., they are not bound to use only the first choice oil). Pain and anxiety will be measured prior to receiving the essential oils and again after the phlebotomy procedure. Blood pressure and pulse will also be measured post-phlebotomy. |
| Standard of Care | No intervention | –The participants randomized to standard of care will proceed to the outpatient phlebotomy room in the Heart Care Clinic as per usual care. Pain, anxiety, blood pressure and pulse will be assessed pre and post-procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be at least 18 years of age
- Must be currently participating in a clinical trial at HealthEast
Key exclusion criteria (3 listed)
- Known allergy to any of the oils used for aromatherapy
- Less than age 18
- Declined to participate
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 |
|---|---|---|
| Essential OilParticipants in this arm will be offered one of three essential oils: ginger, lavender or calming | Other | Aromatherapy |
Primary outcome
Change in Pain Scores
Time frame: At the time of study enrollment and again upon completion at 6 months
Change in Anxiety Scores
Time frame: At the time of study enrollment and again upon completion at 6 months
2 secondary outcomes
Number of venipunctures needed to collect required sample
Time frame: At the time of study completion at 6 months
Number of blood collection tubes required for sample
Time frame: At the time of study completion at 6 months
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 27 Feb 2018.
- Healing scents. (2015). Retrieved 12/23, 2015Link provided by the sponsor.
- Tissearnd, R. (2011). Gattefossé's burn. Retrieved 12/23, 2015Link provided by the sponsor.
- Individual participant dataSharing planned: No. Study results will be shared with the organization and submitted for publication. Individual participant data will not be shared.
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.
Beth Jorgeonson, RN, BSN principal investigator
HealthEast Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential Oil in people with Phobia Phlebotomy, run by HealthEast Care System 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 2 inclusion and 3 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 27 Feb 2018. 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 Pain Scores (time frame: At the time of study enrollment and again upon completion at 6 months). The study lists 2 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 27 Feb 2018.