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

Primary Purpose

Bariatric Surgery Candidate, Nausea, Postoperative

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peppermint oil aromatherapy
Sponsored by
Lancaster General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bariatric Surgery Candidate

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lancaster General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Nausea Assessment and Treatment Scale
Severity of post-operative nausea on a scale of 0-10
Count of Antiemetic Drug Therapies
Number of antiemetic drug therapies used in the post-operative period
Perception of Postoperative Nausea Management Survey
Patient satisfaction with effectiveness of postoperative nausea management

Secondary Outcome Measures

Full Information

First Posted
April 21, 2017
Last Updated
February 18, 2020
Sponsor
Lancaster General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03130218
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
September 10, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lancaster General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Nausea, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized by day of week
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Peppermint oil aromatherapy
Intervention Description
Aroma therapy with peppermint oil administered with presoaked diffuser and bag.
Primary Outcome Measure Information:
Title
Nausea Assessment and Treatment Scale
Description
Severity of post-operative nausea on a scale of 0-10
Time Frame
4 Hours
Title
Count of Antiemetic Drug Therapies
Description
Number of antiemetic drug therapies used in the post-operative period
Time Frame
4 Hours
Title
Perception of Postoperative Nausea Management Survey
Description
Patient satisfaction with effectiveness of postoperative nausea management
Time Frame
24 Hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
14770380
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.
Results Reference
background
PubMed Identifier
9378876
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.
Results Reference
background
PubMed Identifier
22034523
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.
Results Reference
background
Links:
URL
http://www.ihi.org/resources/Pages/Tools/NauseaAssessmentandTreatmentScale.aspx
Description
Institute for Healthcare Improvement (2016). Nausea assessment and treatment scale

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

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