Bariatric Surgery CandidateNCT03130218
Aromatherapy in Management of Postoperative Nausea in Post-Bariatric Surgery Patients
A study testing Peppermint oil aromatherapy in people with Bariatric Surgery Candidate and Nausea, Postoperative, run by Lancaster General Hospital at 1 site in United States.
Trial summary
Determine the effectiveness of peppermint oil aromatherapy in relieving post-operative nausea in the bariatric surgery patient population. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bariatric Surgery Candidate, Nausea, Postoperative
- What is being tested?
- Peppermint oil aromatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2017to 31 Dec 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bariatric surgery candidate on 7-Lime at Lancaster General Hospital
- Scheduled for laparoscopic sleeve gastrectomy and laparoscopic Roux-En-Y (RNY) procedures
- Between ages of 18 and 70
- Surgical patient of either Dr. James Ku and Dr. Joseph McPhee
Who cannot join
- History of excessive sensitivity to peppermint oil, allergic response to peppermint oil and who state preference against aromatherapy
- Not alert and oriented or unable to follow directions will be excluded
- Severe reactive airway disease such as asthma or chronic obstructive pulmonary disease (COPD)
- Possible exclusion for severe hypertension or atrial fibrillation
Trial locations and contacts
1 site in 1 country.
United States1 site
Lancaster General Hospital
Lancaster, Pennsylvania, 17604
About this study
Determine the effectiveness of peppermint oil aromatherapy in relieving post-operative nausea in the bariatric surgery patient population.
Read the detailed description
Healthy weight management and use of essential oils and aromatherapy as natural interventions to manage health-related issues are significantly growing interests. One frequent intervention for healthy weight management is bariatric surgery. In the post-operative period following bariatric surgery, nausea is a common consequence. Peppermint oil aromatherapy is an effective intervention for relieving nausea and other gastrointestinal symptoms in the bariatric and surgical population. This study has multiple aims. One is to determine effectiveness of peppermint oil aromatherapy in relieving post-operative nausea in the bariatric surgery patient population. A second aim is to establish relative cost-effectiveness of peppermint oil aromatherapy versus traditional anti-emetic drug therapies. A third is to determine whether peppermint oil aromatherapy increases patient satisfaction versus anti-emetic drug therapies. This is a randomized study with control and experimental groups. The control group will receive no peppermint oil aromatherapy and only traditional anti-emetics as needed. The experimental group will receive peppermint oil aromatherapy and traditional anti-emetics as needed.
- Conditions
- Bariatric Surgery Candidate, Nausea, Postoperative
- Being tested
- Peppermint oil aromatherapy
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peppermint oil aromatherapyOther
Aroma therapy with peppermint oil administered with presoaked diffuser and bag.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in the control group will not receive peppermint oil aromatherapy as a primary intervention for postoperative nausea and vomiting. Primary therapy for postoperative nausea and vomiting would entail standard antiemetic drug therapies. Patient monitoring and documentation would include the following: Patients in the control group will be assessed every 4 hours and as needed for nausea. All aspects of care from physician, nursing and all disciplines will be consistent with current practices in care of postoperative bariatric surgical patients. |
| Intervention | Experimental | Patients in the intervention group will receive peppermint oil aromatherapy as primary treatment for postoperative nausea. Pharmacological therapy with anti-nausea drug therapies will be available as needed. All other aspects of medical, surgical and nursing care will be standard practice for pre and post-operative care related to the bariatric surgical patient. Patients in the intervention group will be assessed every 4 hours and as needed for nausea. Post-intervention, the patient will be re-assessed for level of nausea after one hour. In the event the patient refuses peppermint oil aromatherapy and requests anti-emetic drug therapies, they are able to do so. Receives: Other: Peppermint oil aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea Assessment and Treatment Scale
Severity of post-operative nausea on a scale of 0-10
Measured: 4 Hours
Count of Antiemetic Drug Therapies
Number of antiemetic drug therapies used in the post-operative period
Measured: 4 Hours
Perception of Postoperative Nausea Management Survey
Patient satisfaction with effectiveness of postoperative nausea management
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start8 Jun 2017
- Primary completion10 Sep 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized by day of week
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancaster General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130218
- Sponsor's protocol ID
- 2016-74-LGH
- Status last verified
- Feb 2020
- First submitted
- 21 Apr 2017
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson LA, Gross JB. Aromatherapy with peppermint, isopropyl alcohol, or placebo is equally effective in relieving postoperative nausea. J Perianesth Nurs. 2004 Feb;19(1):29-35. doi: 10.1016/j.jopan.2003.11.001.
PubMed 14770380Tate S. Peppermint oil: a treatment for postoperative nausea. J Adv Nurs. 1997 Sep;26(3):543-9. doi: 10.1046/j.1365-2648.1997.t01-15-00999.x.
PubMed 9378876Lane B, Cannella K, Bowen C, Copelan D, Nteff G, Barnes K, Poudevigne M, Lawson J. Examination of the effectiveness of peppermint aromatherapy on nausea in women post C-section. J Holist Nurs. 2012 Jun;30(2):90-104; quiz 105-6. doi: 10.1177/0898010111423419. Epub 2011 Oct 27.
PubMed 22034523
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy in Management of Postoperative Nausea in Post-Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT03130218
- Acronym / sponsor ID
- 2016-74-LGH
- Conditions
- Bariatric Surgery Candidate, Nausea, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Lancaster General HospitalUniversity, hospital or other
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Apr 2017 (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.
Determine the effectiveness of peppermint oil aromatherapy in relieving post-operative nausea in the bariatric surgery patient population.
Detailed description
Healthy weight management and use of essential oils and aromatherapy as natural interventions to manage health-related issues are significantly growing interests. One frequent intervention for healthy weight management is bariatric surgery. In the post-operative period following bariatric surgery, nausea is a common consequence. Peppermint oil aromatherapy is an effective intervention for relieving nausea and other gastrointestinal symptoms in the bariatric and surgical population. This study has multiple aims. One is to determine effectiveness of peppermint oil aromatherapy in relieving post-operative nausea in the bariatric surgery patient population. A second aim is to establish relative cost-effectiveness of peppermint oil aromatherapy versus traditional anti-emetic drug therapies. A third is to determine whether peppermint oil aromatherapy increases patient satisfaction versus anti-emetic drug therapies. This is a randomized study with control and experimental groups. The control group will receive no peppermint oil aromatherapy and only traditional anti-emetics as needed. The experimental group will receive peppermint oil aromatherapy and traditional anti-emetics as needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized by day of week
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in the control group will not receive peppermint oil aromatherapy as a primary intervention for postoperative nausea and vomiting. Primary therapy for postoperative nausea and vomiting would entail standard antiemetic drug therapies. Patient monitoring and documentation would include the following: Patients in the control group will be assessed every 4 hours and as needed for nausea. All aspects of care from physician, nursing and all disciplines will be consistent with current practices in care of postoperative bariatric surgical patients. |
| Intervention | Experimental | Other: Peppermint oil aromatherapyPatients in the intervention group will receive peppermint oil aromatherapy as primary treatment for postoperative nausea. Pharmacological therapy with anti-nausea drug therapies will be available as needed. All other aspects of medical, surgical and nursing care will be standard practice for pre and post-operative care related to the bariatric surgical patient. Patients in the intervention group will be assessed every 4 hours and as needed for nausea. Post-intervention, the patient will be re-assessed for level of nausea after one hour. In the event the patient refuses peppermint oil aromatherapy and requests anti-emetic drug therapies, they are able to do so. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Bariatric surgery candidate on 7-Lime at Lancaster General Hospital
- Scheduled for laparoscopic sleeve gastrectomy and laparoscopic Roux-En-Y (RNY) procedures
- Between ages of 18 and 70
- Surgical patient of either Dr. James Ku and Dr. Joseph McPhee
Key exclusion criteria (4 listed)
- History of excessive sensitivity to peppermint oil, allergic response to peppermint oil and who state preference against aromatherapy
- Not alert and oriented or unable to follow directions will be excluded
- Severe reactive airway disease such as asthma or chronic obstructive pulmonary disease (COPD)
- Possible exclusion for severe hypertension or atrial fibrillation
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 |
|---|---|---|
| Peppermint oil aromatherapyAroma therapy with peppermint oil administered with presoaked diffuser and bag. | Other | Intervention |
Primary outcome
Nausea Assessment and Treatment Scale
Time frame: 4 Hours
Severity of post-operative nausea on a scale of 0-10
Count of Antiemetic Drug Therapies
Time frame: 4 Hours
Number of antiemetic drug therapies used in the post-operative period
Perception of Postoperative Nausea Management Survey
Time frame: 24 Hours
Patient satisfaction with effectiveness of postoperative nausea management
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 19 Feb 2020.
- Background: PubMed 14770380Anderson LA, Gross JB. Aromatherapy with peppermint, isopropyl alcohol, or placebo is equally effective in relieving postoperative nausea. J Perianesth Nurs. 2004 Feb;19(1):29-35. doi: 10.1016/j.jopan.2003.11.001.
- Background: PubMed 9378876Tate S. Peppermint oil: a treatment for postoperative nausea. J Adv Nurs. 1997 Sep;26(3):543-9. doi: 10.1046/j.1365-2648.1997.t01-15-00999.x.
- Background: PubMed 22034523Lane B, Cannella K, Bowen C, Copelan D, Nteff G, Barnes K, Poudevigne M, Lawson J. Examination of the effectiveness of peppermint aromatherapy on nausea in women post C-section. J Holist Nurs. 2012 Jun;30(2):90-104; quiz 105-6. doi: 10.1177/0898010111423419. Epub 2011 Oct 27.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peppermint oil aromatherapy in people with Bariatric Surgery Candidate and Nausea, Postoperative, run by Lancaster General Hospital 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 4 inclusion and 4 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 19 Feb 2020. 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?
Nausea Assessment and Treatment Scale (time frame: 4 Hours). The study lists 3 primary outcomes in all. 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 NCT03130218, which also lists 3 linked publications.
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 19 Feb 2020.