NCT02189980

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

2.2 years

First QC Date

July 11, 2014

Last Update Submit

January 14, 2016

Conditions

Post-operative Nausea

Keywords

NauseaPost-operative

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Participant comfort using the nasal clip delivery system

    Immediately post-op to one-day post-op

Study Arms (2)

Saline & nasal clip

PLACEBO COMPARATOR

Saline and nasal clip inhaled post-operatively

Other: Duration of effectiveness of the essential oil blendOther: Participant comfort using the nasal clip delivery system

Aromatherapy blend & nasal clip

EXPERIMENTAL

Aromatherapy blend and nasal clip inhaled post-operatively

Other: Aromatherapy blendOther: Duration of effectiveness of the essential oil blendOther: Participant comfort using the nasal clip delivery system

Interventions

Aromatherapy blendOTHER

A blend of 45% ginger, 25% peppermint, 5% spearmint, and 25% cardamom essential oils

Aromatherapy blend & nasal clip
Duration of effectiveness of the essential oil blendOTHER

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.

Aromatherapy blend & nasal clipSaline & nasal clip
Participant comfort using the nasal clip delivery systemOTHER

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.

Aromatherapy blend & nasal clipSaline & nasal clip

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMC -- University

Charlotte, North Carolina, 28262, United States

RECRUITING

MeSH Terms

Conditions

Nausea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ronald Hunt, MD

    Balanced Health plus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronald Hunt, MD

CONTACT

704-604-5031rhunt@balancedhealthplus.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 15, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

January 15, 2016

Record last verified: 2016-01

Locations

US(1)