Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE April 21, 2017
First Posted Date  ICMJE April 26, 2017
Last Update Posted Date December 6, 2018
Actual Study Start Date  ICMJE June 8, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2017)
  • Nausea Assessment and Treatment Scale [ Time Frame: 4 Hours ]
    Severity of post-operative nausea on a scale of 0-10
  • Count of Antiemetic Drug Therapies [ Time Frame: 4 Hours ]
    Number of antiemetic drug therapies used in the post-operative period
  • Perception of Postoperative Nausea Management Survey [ Time Frame: 24 Hours ]
    Patient satisfaction with effectiveness of postoperative nausea management
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03130218 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aromatherapy in Management of Postoperative Nausea in Post-Bariatric Surgery Patients
Official Title  ICMJE Aromatherapy in Management of Postoperative Nausea in Post-Bariatric Surgery Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized by day of week
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Bariatric Surgery Candidate
  • Nausea, Postoperative
Intervention  ICMJE Other: Peppermint oil aromatherapy
Aroma therapy with peppermint oil administered with presoaked diffuser and bag.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Peppermint oil aromatherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2017)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aarin Deibler, RN, BSN (717) 544-7762 aldeible@lghealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03130218
Other Study ID Numbers  ICMJE 2016-74-LGH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lancaster General Hospital
Study Sponsor  ICMJE Lancaster General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lancaster General Hospital
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP