Clinical trial NCT03130218: Aromatherapy in Management of Postoperative Nausea in Post-Bariatric Surgery Patients
Official title: Aromatherapy in Management of Postoperative Nausea in Post-Bariatric Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Nausea, Postoperative
Lead sponsor: Lancaster General Hospital
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized by day of week
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Nausea Assessment and Treatment Scale
timeFrame: 4 Hours
measure: Count of Antiemetic Drug Therapies
timeFrame: 4 Hours
measure: Perception of Postoperative Nausea Management Survey
timeFrame: 24 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
Study officials:
References:
citation: 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.
citation: Tate 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.
citation: Lane 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.