Post-operative NauseaNCT02189980
Aromatherapy Using a Nasal Clip After Surgery
A study testing Aromatherapy blend, Duration of effectiveness of the essential oil blend and Participant comfort using the nasal clip delivery system in people with Post-operative Nausea, run by Balanced Health plus at 1 site in United States.
Trial summary
The purpose of this follow up study is to determine the duration of action regarding aromatherapy to treat nausea occurring postoperatively. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-operative Nausea
- What is being tested?
- Aromatherapy blend, Duration of effectiveness of the essential oil blend and Participant comfort using the nasal clip delivery system
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Aug 2016
- 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
- 18 years or over
- cognitively able to give consent based on nurse's assessment,
- having gynecological or other abdominal surgery
- not allergic to peppermint, spearmint, cardamom or ginger
- not receiving blood thinning medications
Who cannot join
- less than 18 years old
- unable to cognitively give consent
- allergic to ginger, peppermint, cardamom or spearmint.
- receiving warfarin (Coumadin) or any antiplatelet drug (heparin, 325 mg Aspirin, clopidogrel (Plavix) or other) or a diagnosis of bleeding diatheses (predisposition to abnormal blood clotting/hemorrhage) will not be included in this study.
- all surgeries other than gynecological or abdominal surgery
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
CMC -- University
Charlotte, North Carolina, 28262
Ronald Hunt, MD, 704-604-5031, rhunt@balancedhealthplus.com
About this study
The purpose of this follow up study is to determine the duration of action regarding aromatherapy to treat nausea occurring postoperatively.
Read the detailed description
The primary hypothesis of the study is that post-operative patients who meet eligibility criteria and report nausea and receive a blend of 45% ginger, 25% peppermint, 5% spearmint, and 25% cardamom essential oils while using a nasal clip to facilitate inhalation will have more relief from nausea than those who receive normal saline inhalation using the same delivery system.
The secondary purposes of the study is to determine the duration of effectiveness of the essential oil blend as compared to the saline in the relief of post-operative nausea and to investigate the degree of comfort participants report using the nasal clip delivery system for aromatherapy.
- Conditions
- Post-operative Nausea
- Being tested
- Aromatherapy blend, Duration of effectiveness of the essential oil blend, Participant comfort using the nasal clip delivery system
- Keywords
- Nausea, Post-operative
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy blendOther
A blend of 45% ginger, 25% peppermint, 5% spearmint, and 25% cardamom essential oils
Duration of effectiveness of the essential oil blendOther
Evidence of effectiveness of tested aromatherapy blend in reducing symptoms of post-operative nausea as measured by patient self-report using Likert-type scale measure immediately to one-day post-operative.
Participant comfort using the nasal clip delivery systemOther
Comfort of participants using nasal clip delivery system for aromatherapy will be measured by self-report using Likert-type scale immediately to one-day post-operative.
| Study group | Role | What they receive |
|---|---|---|
| Saline & nasal clip | Placebo comparator | Saline and nasal clip inhaled post-operatively Receives: Other: Duration of effectiveness of the essential oil blend; Other: Participant comfort using the nasal clip delivery system |
| Aromatherapy blend & nasal clip | Experimental | Aromatherapy blend and nasal clip inhaled post-operatively Receives: Other: Aromatherapy blend; Other: Duration of effectiveness of the essential oil blend; Other: Participant comfort using the nasal clip delivery system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of effectiveness of the essential oil blend
Evidence of effectiveness of tested aromatherapy blend in reducing symptoms of post-operative nausea as measured by patient self-report using Likert-type scale measure.
Measured: Immediately to one-day post-operative
Secondary outcomes (1)
Participant comfort using the nasal clip delivery system
Comfort of participants using nasal clip delivery system for aromatherapy will be measured by self-report using Likert-type scale.
Measured: Immediately post-op to one-day post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative NauseaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balanced Health plus
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wake Forest University Health Sciences
- Responsible party
- Sponsor
- Investigators
- Ronald Hunt, MD, Principal investigator, Balanced Health plus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189980
- Sponsor's protocol ID
- BHp2014-001
- Status last verified
- Jan 2016
- First submitted
- 11 Jul 2014
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy Using a Nasal Clip After Surgery
- ClinicalTrials.gov ID
- NCT02189980
- Acronym / sponsor ID
- BHp2014-001
- Conditions
- Post-operative Nausea
- Keywords
- Nausea, Post-operative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Balanced Health plusIndustry (pharma, biotech, devices)
- Collaborators
- Wake Forest University Health Sciences
- Study start
- Jun 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 15 Jul 2014 (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.
The purpose of this follow up study is to determine the duration of action regarding aromatherapy to treat nausea occurring postoperatively.
Detailed description
The primary hypothesis of the study is that post-operative patients who meet eligibility criteria and report nausea and receive a blend of 45% ginger, 25% peppermint, 5% spearmint, and 25% cardamom essential oils while using a nasal clip to facilitate inhalation will have more relief from nausea than those who receive normal saline inhalation using the same delivery system.
The secondary purposes of the study is to determine the duration of effectiveness of the essential oil blend as compared to the saline in the relief of post-operative nausea and to investigate the degree of comfort participants report using the nasal clip delivery system for aromatherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline & nasal clip | Placebo comparator | Other: Duration of effectiveness of the essential oil blend, Other: Participant comfort using the nasal clip delivery systemSaline and nasal clip inhaled post-operatively |
| Aromatherapy blend & nasal clip | Experimental | Other: Aromatherapy blend, Other: Duration of effectiveness of the essential oil blend, Other: Participant comfort using the nasal clip delivery systemAromatherapy blend and nasal clip inhaled post-operatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or over
- cognitively able to give consent based on nurse's assessment,
- having gynecological or other abdominal surgery
- not allergic to peppermint, spearmint, cardamom or ginger
- not receiving blood thinning medications
Key exclusion criteria (5 listed)
- less than 18 years old
- unable to cognitively give consent
- allergic to ginger, peppermint, cardamom or spearmint.
- receiving warfarin (Coumadin) or any antiplatelet drug (heparin, 325 mg Aspirin, clopidogrel (Plavix) or other) or a diagnosis of bleeding diatheses (predisposition to abnormal blood clotting/hemorrhage) will not be included in this study.
- all surgeries other than gynecological or abdominal surgery
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 |
|---|---|---|
| Aromatherapy blendA blend of 45% ginger, 25% peppermint, 5% spearmint, and 25% cardamom essential oils | Other | Aromatherapy blend & nasal clip |
| Duration of effectiveness of the essential oil blendEvidence of effectiveness of tested aromatherapy blend in reducing symptoms of post-operative nausea as measured by patient self-report using Likert-type scale measure immediately to one-day post-operative. | Other | Aromatherapy blend & nasal clip, Saline & nasal clip |
| Participant comfort using the nasal clip delivery systemComfort of participants using nasal clip delivery system for aromatherapy will be measured by self-report using Likert-type scale immediately to one-day post-operative. | Other | Aromatherapy blend & nasal clip, Saline & nasal clip |
Primary outcome
Duration of effectiveness of the essential oil blend
Time frame: Immediately to one-day post-operative
Evidence of effectiveness of tested aromatherapy blend in reducing symptoms of post-operative nausea as measured by patient self-report using Likert-type scale measure.
1 secondary outcome
Participant comfort using the nasal clip delivery system
Time frame: Immediately post-op to one-day post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
Related trials for Post-operative Nausea
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PONV
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
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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.
Ronald Hunt, MD principal investigator
Balanced Health plus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy blend, Duration of effectiveness of the essential oil blend and Participant comfort using the nasal clip delivery system in people with Post-operative Nausea, run by Balanced Health plus 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 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: status not confirmed, as of the sponsor's last update on 15 Jan 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronald Hunt, MD (704-604-5031, rhunt@balancedhealthplus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of effectiveness of the essential oil blend (time frame: Immediately to one-day post-operative). 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 15 Jan 2016.