Aromatherapy Using a Nasal Clip After Surgery

January 14, 2016 updated by: Balanced Health plus
The purpose of this follow up study is to determine the duration of action regarding aromatherapy to treat nausea occurring postoperatively.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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: 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.
Other: Aromatherapy blend
A blend of 45% ginger, 25% peppermint, 5% spearmint, and 25% cardamom essential oils

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately to one-day post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately post-op to one-day post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balanced Health plus

Collaborators

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Ronald Hunt, MD, Balanced Health plus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

July 11, 2014

First Submitted That Met QC Criteria

July 11, 2014

First Posted (Estimate)

July 15, 2014

Study Record Updates

Last Update Posted (Estimate)

January 15, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHp2014-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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