Recruiting

Aromatherapy

Sponsor:

Balanced Health plus

Code:

NCT02189980

Conditions

Post-operative Nausea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Aromatherapy blend

Duration of effectiveness of the essential oil blend

Participant comfort using the nasal clip delivery system

Study Details

Brief summary:

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

Conditions

Post-operative Nausea

Study ID

NCT02189980

Start date

Jun, 2014

Status verified date

Jan, 2016

Completion date

Aug, 2016

Anticipated

Primary completion date

Aug, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

placebo comparator: Saline & nasal clip

Saline and nasal clip inhaled post-operatively

experimental: Aromatherapy blend & nasal clip

Aromatherapy blend and nasal clip inhaled post-operatively

Interventions

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.

Primary outcome measure

  • Duration of effectiveness of the essential oil blend [ Time Frame: Immediately to one-day post-operative ]

Central Contacts and Locations

Central contacts

Ronald Hunt, MD

704-604-5031rhunt@balancedhealthplus.com

Locations

CMC -- University

Recruiting

Charlotte, North Carolina, United States, 28262

Contacts

Ronald Hunt, MD

704-604-5031rhunt@balancedhealthplus.com

More Information

Sponsor

Balanced Health plus

Last update posted

Jan 15, 2016

Last verified

Jan, 2016

Keywords

  • Nausea
  • Post-operative

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Balanced Health plus on 2016-01-15.