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

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ClinicalTrials.gov Identifier: NCT03130218
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Lancaster General Hospital

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
Bariatric Surgery Candidate Nausea, Postoperative Other: Peppermint oil aromatherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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 : June 8, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Nausea Assessment and Treatment Scale [ Time Frame: 4 Hours ]
    Severity of post-operative nausea on a scale of 0-10

  2. Count of Antiemetic Drug Therapies [ Time Frame: 4 Hours ]
    Number of antiemetic drug therapies used in the post-operative period

  3. Perception of Postoperative Nausea Management Survey [ Time Frame: 24 Hours ]
    Patient satisfaction with effectiveness of postoperative nausea management



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130218


Contacts
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Contact: Aarin Deibler, RN, BSN (717) 544-7762 aldeible@lghealth.org

Locations
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United States, Pennsylvania
Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17604
Sponsors and Collaborators
Lancaster General Hospital

Additional Information:
Publications:
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Responsible Party: Lancaster General Hospital
ClinicalTrials.gov Identifier: NCT03130218     History of Changes
Other Study ID Numbers: 2016-74-LGH
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Nausea
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Vomiting
Peppermint oil
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Parasympatholytics