Aromatherapy Using a Nasal Clip After Surgery

Post-operative Nausea Clinical Trial

Official title:

Aromatherapy Using a Nasal Clip After Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02189980
• Other study ID #: BHp2014-001
• Status: Recruiting
• Phase: N/A
• First received: July 11, 2014
• Last updated: January 14, 2016
• Start date: June 2014
• Est. completion date: August 2016

Study information

• Verified date: January 2016
• Source: Balanced Health plus
• Contact: Ronald Hunt, MD
• Phone: 704-604-5031
• Email: rhunt[@]balancedhealthplus.com
• Is FDA regulated: No
• Health authority: United States: Carolinas Healthcare System IRB
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Post-operative Nausea

Intervention

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

Locations

Country	Name	City	State
United States	CMC -- University	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Balanced Health plus	Carolinas Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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 post-op to one-day post-op	No