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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

Tracking Information
First Submitted Date  ICMJE July 11, 2014
First Posted Date  ICMJE July 15, 2014
Last Update Posted Date January 15, 2016
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
The 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2014)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
Assess comfort participants report 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aromatherapy Using a Nasal Clip After Surgery
Official Title  ICMJE Aromatherapy Using a Nasal Clip After Surgery
Brief Summary The purpose of this follow up study is to determine the duration of action regarding aromatherapy to treat nausea occurring postoperatively.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Post-operative Nausea
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Placebo Comparator: Saline & nasal clip
    Saline and nasal clip inhaled post-operatively
    Interventions:
    • Other: Duration of effectiveness of the essential oil blend
    • Other: Participant comfort using the nasal clip delivery system
  • Experimental: Aromatherapy blend & nasal clip
    Aromatherapy blend and nasal clip inhaled post-operatively
    Interventions:
    • Other: Aromatherapy blend
    • Other: Duration of effectiveness of the essential oil blend
    • Other: Participant comfort using the nasal clip delivery system
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 11, 2014)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2016
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02189980
Other Study ID Numbers  ICMJE BHp2014-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Balanced Health plus
Study Sponsor  ICMJE Balanced Health plus
Collaborators  ICMJE Atrium Health
Investigators  ICMJE
Principal Investigator: Ronald Hunt, MD Balanced Health plus
PRS Account Balanced Health plus
Verification Date January 2016

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