Clincosm LogoSign in Get a demo

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

Sponsor
Lancaster General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03130218
Collaborator
(none)
204
Enrollment
1
Location
2
Arms
30.8
Actual Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Peppermint oil aromatherapy
 N/A

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

Study Type:
Interventional
Actual Enrollment :
204 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized by day of weekRandomized by day of week
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Aromatherapy in Management of Postoperative Nausea in Post-Bariatric Surgery Patients
Actual Study Start Date :
Jun 8, 2017
Actual Primary Completion Date :
Sep 10, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
No Intervention: 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.
Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Nausea Assessment and Treatment Scale [4 Hours]

    Severity of post-operative nausea on a scale of 0-10

  2. Count of Antiemetic Drug Therapies [4 Hours]

    Number of antiemetic drug therapies used in the post-operative period

  3. Perception of Postoperative Nausea Management Survey [24 Hours]

    Patient satisfaction with effectiveness of postoperative nausea management

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lancaster General Hospital Lancaster Pennsylvania United States 17604

Sponsors and Collaborators

  • Lancaster General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Lancaster General Hospital
ClinicalTrials.gov Identifier:
NCT03130218
Other Study ID Numbers:
  • 2016-74-LGH
First Posted:
Apr 26, 2017
Last Update Posted:
Feb 19, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Nausea
Postoperative Nausea and Vomiting
Peppermint oil

Study Results

No Results Posted as of Feb 19, 2020