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Aromatherapy Using a Nasal Clip After Surgery

B

Balanced Health plus

Status

Unknown

Conditions

Post-operative Nausea

Treatments

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

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02189980
BHp2014-001

Details and patient eligibility

About

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

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

300 participants in 2 patient groups, including a placebo group

Saline & nasal clip
Placebo Comparator group
Description:
Saline and nasal clip inhaled post-operatively
Treatment:
Other: Participant comfort using the nasal clip delivery system
Other: Duration of effectiveness of the essential oil blend
Aromatherapy blend & nasal clip
Experimental group
Description:
Aromatherapy blend and nasal clip inhaled post-operatively
Treatment:
Other: Participant comfort using the nasal clip delivery system
Other: Aromatherapy blend
Other: Duration of effectiveness of the essential oil blend

Trial contacts and locations

1

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Central trial contact

Ronald Hunt, MD

Data sourced from clinicaltrials.gov

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