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

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130218
• Other study ID #: 2016-74-LGH
• Status: Completed
• Phase: N/A
• Start date: June 8, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Lancaster General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determine the effectiveness of peppermint oil aromatherapy in relieving post-operative nausea in the bariatric surgery patient population.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 31, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Nausea
• Nausea, Postoperative
• Postoperative Nausea and Vomiting

Intervention

Other:
• Peppermint oil aromatherapy
Aroma therapy with peppermint oil administered with presoaked diffuser and bag.

Locations

Country	Name	City	State
United States	Lancaster General Hospital	Lancaster	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lancaster General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View Citation

Tate S. Peppermint oil: a treatment for postoperative nausea. J Adv Nurs. 1997 Sep;26(3):543-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nausea Assessment and Treatment Scale	Severity of post-operative nausea on a scale of 0-10	4 Hours
Primary	Count of Antiemetic Drug Therapies	Number of antiemetic drug therapies used in the post-operative period	4 Hours
Primary	Perception of Postoperative Nausea Management Survey	Patient satisfaction with effectiveness of postoperative nausea management	24 Hours

External Links

•   Institute for Healthcare Improvement (2016). Nausea assessment and treatment scale