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Trial record 58 of 238 for:    essential oil

Aromatherapy Using a Nasal Clip After Surgery

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ClinicalTrials.gov Identifier: NCT02189980
Recruitment Status : Unknown
Verified January 2016 by Balanced Health plus.
Recruitment status was:  Recruiting
First Posted : July 15, 2014
Last Update Posted : January 15, 2016
Sponsor:
Collaborator:
Atrium Health
Information provided by (Responsible Party):
Balanced Health plus

Brief Summary:
The purpose of this follow up study is to determine the duration of action regarding aromatherapy to treat nausea occurring postoperatively.

Condition or disease Intervention/treatment Phase
Post-operative Nausea Other: Aromatherapy blend Other: Duration of effectiveness of the essential oil blend Other: Participant comfort using the nasal clip delivery system Not Applicable

Detailed Description:

The primary hypothesis of the study is that post-operative patients who meet eligibility criteria and report nausea and receive a blend of 45% ginger, 25% peppermint, 5% spearmint, and 25% cardamom essential oils while using a nasal clip to facilitate inhalation will have more relief from nausea than those who receive normal saline inhalation using the same delivery system.

The secondary purposes of the study is to determine the duration of effectiveness of the essential oil blend as compared to the saline in the relief of post-operative nausea and to investigate the degree of comfort participants report using the nasal clip delivery system for aromatherapy.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Aromatherapy Using a Nasal Clip After Surgery
Study Start Date : June 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Saline & nasal clip
Saline and nasal clip inhaled post-operatively
Other: Duration of effectiveness of the essential oil blend
Evidence of effectiveness of tested aromatherapy blend in reducing symptoms of post-operative nausea as measured by patient self-report using Likert-type scale measure immediately to one-day post-operative.

Other: Participant comfort using the nasal clip delivery system
Comfort of participants using nasal clip delivery system for aromatherapy will be measured by self-report using Likert-type scale immediately to one-day post-operative.

Experimental: Aromatherapy blend & nasal clip
Aromatherapy blend and nasal clip inhaled post-operatively
Other: Aromatherapy blend
A blend of 45% ginger, 25% peppermint, 5% spearmint, and 25% cardamom essential oils

Other: Duration of effectiveness of the essential oil blend
Evidence of effectiveness of tested aromatherapy blend in reducing symptoms of post-operative nausea as measured by patient self-report using Likert-type scale measure immediately to one-day post-operative.

Other: Participant comfort using the nasal clip delivery system
Comfort of participants using nasal clip delivery system for aromatherapy will be measured by self-report using Likert-type scale immediately to one-day post-operative.




Primary Outcome Measures :
  1. Duration of effectiveness of the essential oil blend [ Time Frame: Immediately to one-day post-operative ]
    Evidence of effectiveness of tested aromatherapy blend in reducing symptoms of post-operative nausea as measured by patient self-report using Likert-type scale measure.


Secondary Outcome Measures :
  1. Participant comfort using the nasal clip delivery system [ Time Frame: Immediately post-op to one-day post-op ]
    Comfort of participants using nasal clip delivery system for aromatherapy will be measured by self-report using Likert-type scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years or over
  • cognitively able to give consent based on nurse's assessment,
  • having gynecological or other abdominal surgery
  • not allergic to peppermint, spearmint, cardamom or ginger
  • not receiving blood thinning medications

Exclusion Criteria:

  • less than 18 years old
  • unable to cognitively give consent
  • allergic to ginger, peppermint, cardamom or spearmint.
  • receiving warfarin (Coumadin) or any antiplatelet drug (heparin, 325 mg Aspirin, clopidogrel (Plavix) or other) or a diagnosis of bleeding diatheses (predisposition to abnormal blood clotting/hemorrhage) will not be included in this study.
  • all surgeries other than gynecological or abdominal surgery

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): NCT02189980


Contacts
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Contact: Ronald Hunt, MD 704-604-5031 rhunt@balancedhealthplus.com

Locations
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United States, North Carolina
CMC -- University Recruiting
Charlotte, North Carolina, United States, 28262
Contact: Ronald Hunt, MD    704-604-5031    rhunt@balancedhealthplus.com   
Sponsors and Collaborators
Balanced Health plus
Atrium Health
Investigators
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Principal Investigator: Ronald Hunt, MD Balanced Health plus

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Responsible Party: Balanced Health plus
ClinicalTrials.gov Identifier: NCT02189980     History of Changes
Other Study ID Numbers: BHp2014-001
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016
Keywords provided by Balanced Health plus:
Nausea
Post-operative
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
Adrenocorticotropic Hormone
Melanocyte-Stimulating Hormones
beta-Endorphin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action