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Aromatherapy Using a Nasal Clip After Surgery

Primary Purpose

Post-operative Nausea

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aromatherapy blend
Duration of effectiveness of the essential oil blend
Participant comfort using the nasal clip delivery system
Sponsored by
Balanced Health plus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post-operative Nausea focused on measuring Nausea, Post-operative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CMC -- UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Saline & nasal clip

Aromatherapy blend & nasal clip

Arm Description

Saline and nasal clip inhaled post-operatively

Aromatherapy blend and nasal clip inhaled post-operatively

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 11, 2014
Last Updated
January 14, 2016
Sponsor
Balanced Health plus
Collaborators
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02189980
Brief Title
Aromatherapy Using a Nasal Clip After Surgery
Official Title
Aromatherapy Using a Nasal Clip After Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Balanced Health plus
Collaborators
Wake Forest University Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Nausea
Keywords
Nausea, Post-operative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saline & nasal clip
Arm Type
Placebo Comparator
Arm Description
Saline and nasal clip inhaled post-operatively
Arm Title
Aromatherapy blend & nasal clip
Arm Type
Experimental
Arm Description
Aromatherapy blend and nasal clip inhaled post-operatively
Intervention Type
Other
Intervention Name(s)
Aromatherapy blend
Intervention Description
A blend of 45% ginger, 25% peppermint, 5% spearmint, and 25% cardamom essential oils
Intervention Type
Other
Intervention Name(s)
Duration of effectiveness of the essential oil blend
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Participant comfort using the nasal clip delivery system
Intervention Description
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 Measure Information:
Title
Duration of effectiveness of the essential oil blend
Description
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.
Time Frame
Immediately to one-day post-operative
Secondary Outcome Measure Information:
Title
Participant comfort using the nasal clip delivery system
Description
Comfort of participants using nasal clip delivery system for aromatherapy will be measured by self-report using Likert-type scale.
Time Frame
Immediately post-op to one-day post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald Hunt, MD
Phone
704-604-5031
Email
rhunt@balancedhealthplus.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Hunt, MD
Organizational Affiliation
Balanced Health plus
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMC -- University
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Hunt, MD
Phone
704-604-5031
Email
rhunt@balancedhealthplus.com

12. IPD Sharing Statement

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Aromatherapy Using a Nasal Clip After Surgery

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