NCT02732379

Brief Summary

The aim of this study is to evaluate the effect of the aromatherapy with lavender, rose or ginger essential oils on nausea, vomiting and postoperative quality of recovery scores in patients with postoperative nausea and vomiting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2018

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

2.6 years

First QC Date

March 30, 2016

Last Update Submit

December 3, 2018

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative Nausea and VomitingAromatherapyQuality of Health Care

Outcome Measures

Primary Outcomes (2)

  • The change of the nausea scores

    Nausea will be measured with verbal descriptive scale on 0 to 3 Likert-type scale(0=no nausea, 1=some, 2= a lot, 3= severe)

    During postoperative 24 hours

  • The change of the vomiting score

    Vomiting will be measured with verbal descriptive scale (0=no vomiting, 1= 1 time, 2= 2 or 3 times, 3= 4 times and up)

    During postoperative 24 hours

Secondary Outcomes (1)

  • The consumption of the antiemetic drug

    During postoperative 24 hours

Study Arms (4)

Lavender Aromatherapy

EXPERIMENTAL

Aromatherapy with lavender essential oil.

Procedure: Lavender Aromatherapy

Rose Aromatherapy

EXPERIMENTAL

Aromatherapy with rose essential oil

Procedure: Rose Aromatherapy

Ginger Aromatherapy

EXPERIMENTAL

Aromatherapy with ginger essential oil

Procedure: Ginger Aromatherapy

Placebo Aromatherapy

PLACEBO COMPARATOR

Aromatherapy with pure water

Procedure: Placebo Aromatherapy

Interventions

Lavender AromatherapyPROCEDURE

the two drops of lavender essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.

Also known as: Aromatherapy with lavender essential oil
Lavender Aromatherapy
Rose AromatherapyPROCEDURE

the two drops of rose essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.

Also known as: Aromatherapy with rose essential oil
Rose Aromatherapy
Ginger AromatherapyPROCEDURE

the two drops of ginger essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.

Also known as: Aromatherapy with ginger essential oil
Ginger Aromatherapy
Placebo AromatherapyPROCEDURE

the two drops of pure water will be dropped into the gauze and the patient will inhale it for 5 minutes

Also known as: Aromatherapy with pure water
Placebo Aromatherapy

Eligibility Criteria

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

You may qualify if:

  • Be scheduled for elective surgery
  • Have a postoperative nausea and vomiting

You may not qualify if:

  • Age \> 65years or \<18 years
  • Not accepted to inhale lavender, rose or ginger oil
  • Preoperative predications with anti emetic drugs
  • Pregnancy or breastfeeding
  • Asthma, Chronic obstructive pulmonary disease
  • Poor sense of smell
  • Allergy to the lavender, rose or ginger oil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University Medical School Hospital

Tokat Province, 60100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Aromatherapylavender oil

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Tugba Karaman, MD

    Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 8, 2016

Study Start

April 1, 2016

Primary Completion

November 13, 2018

Study Completion

November 14, 2018

Last Updated

December 4, 2018

Record last verified: 2018-12

Locations

TU(1)