Aromatherapy Using a Nasal Clip After Surgery

Not Applicable

• Conditions: Post-operative Nausea
• Interventions: Other: Duration of effectiveness of the essential oil blend; Other: Aromatherapy blend; Other: Participant comfort using the nasal clip delivery system

• Registration Number: NCT02189980
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-15
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-14
• Last Update Posted: 2016-01-15
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline & nasal clip	Participant comfort using the nasal clip delivery system	Saline and nasal clip inhaled post-operatively
Aromatherapy blend & nasal clip	Participant comfort using the nasal clip delivery system	Aromatherapy blend and nasal clip inhaled post-operatively
Saline & nasal clip	Duration of effectiveness of the essential oil blend	Saline and nasal clip inhaled post-operatively
Aromatherapy blend & nasal clip	Aromatherapy blend	Aromatherapy blend and nasal clip inhaled post-operatively
Aromatherapy blend & nasal clip	Duration of effectiveness of the essential oil blend	Aromatherapy blend and nasal clip inhaled post-operatively

Primary Outcome Measures

Name	Time	Method
Duration of effectiveness of the essential oil blend	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

Name	Time	Method
Participant comfort using the nasal clip delivery system	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.

Trial Locations

Locations (1)

CMC -- University; 🇺🇸 Charlotte, North Carolina, United States