Aromatherapy in Management of Postoperative Nausea in Post-Bariatric Surgery Patients

NCT ID: NCT03130218

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-08
• Study Completion Date: 2019-12-31

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.

Conditions

Bariatric Surgery Candidate; Nausea, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

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.

Group Type: EXPERIMENTAL

Peppermint oil aromatherapy

Intervention Type: OTHER

Aroma therapy with peppermint oil administered with presoaked diffuser and bag.

Interventions

Peppermint oil aromatherapy

Aroma therapy with peppermint oil administered with presoaked diffuser and bag.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lancaster General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 14770380 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9378876 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22034523 (View on PubMed)

Other Identifiers

2016-74-LGH

Identifier Type: -

Identifier Source: org_study_id