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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03130218|
Recruitment Status : Completed
First Posted : April 26, 2017
Last Update Posted : February 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bariatric Surgery Candidate Nausea, Postoperative||Other: Peppermint oil aromatherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized by day of week|
|Masking:||None (Open Label)|
|Official Title:||Aromatherapy in Management of Postoperative Nausea in Post-Bariatric Surgery Patients|
|Actual Study Start Date :||June 8, 2017|
|Actual Primary Completion Date :||September 10, 2019|
|Actual Study Completion Date :||December 31, 2019|
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.
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.
- 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
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
|United States, Pennsylvania|
|Lancaster General Hospital|
|Lancaster, Pennsylvania, United States, 17604|