Postoperative Nausea and VomitingNCT02732379
Effect of Aromatherapy on Postoperative Nausea, Vomiting
A study testing Lavender Aromatherapy, Rose Aromatherapy and Ginger Aromatherapy in people with Postoperative Nausea and Vomiting, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Lavender Aromatherapy, Rose Aromatherapy and Ginger Aromatherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2016to 14 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be scheduled for elective surgery
- Have a postoperative nausea and vomiting
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University Medical School Hospital
Tokat Province, 60100
About this study
Official title: Evaluating the Efficacy of Aromatherapy on Postoperative Nausea, Vomiting
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.
Read the detailed description
Postoperative Nausea and Vomiting (PONV) relief is still challenge for the anesthesiologist. Pharmacological therapies is also cornerstone for treatment of PONV. Although future researches are needed, there is some proofs about the aromatherapy could provide an inexpensive, noninvasive and effective treatment for PONV.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Lavender Aromatherapy, Rose Aromatherapy, Ginger Aromatherapy, Placebo Aromatherapy
- Keywords
- Postoperative Nausea and Vomiting, Aromatherapy, Quality of Health Care
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender AromatherapyProcedure or surgery
Also called Aromatherapy with lavender essential oil
the two drops of lavender essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.
Rose AromatherapyProcedure or surgery
Also called Aromatherapy with rose essential oil
the two drops of rose essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.
Ginger AromatherapyProcedure or surgery
Also called Aromatherapy with ginger essential oil
the two drops of ginger essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.
Placebo AromatherapyProcedure or surgery
Also called Aromatherapy with pure water
the two drops of pure water will be dropped into the gauze and the patient will inhale it for 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| Lavender Aromatherapy | Experimental | Aromatherapy with lavender essential oil. Receives: Procedure: Lavender Aromatherapy |
| Rose Aromatherapy | Experimental | Aromatherapy with rose essential oil Receives: Procedure: Rose Aromatherapy |
| Ginger Aromatherapy | Experimental | Aromatherapy with ginger essential oil Receives: Procedure: Ginger Aromatherapy |
| Placebo Aromatherapy | Placebo comparator | Aromatherapy with pure water Receives: Procedure: Placebo Aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: During postoperative 24 hours
Secondary outcomes (1)
The consumption of the antiemetic drug
The antiemetic drug dose will be recorded
Measured: During postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion13 Nov 2018
- Study completion14 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Karaman, Tokat Gaziosmanpasa University
- Investigators
- Tugba Karaman, MD, Principal investigator, Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732379
- Sponsor's protocol ID
- PONV
- Status last verified
- Dec 2018
- First submitted
- 30 Mar 2016
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Aromatherapy on Postoperative Nausea, Vomiting
- ClinicalTrials.gov ID
- NCT02732379
- Acronym / sponsor ID
- PONV
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Postoperative Nausea and Vomiting, Aromatherapy, Quality of Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 8 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postoperative Nausea and Vomiting (PONV) relief is still challenge for the anesthesiologist. Pharmacological therapies is also cornerstone for treatment of PONV. Although future researches are needed, there is some proofs about the aromatherapy could provide an inexpensive, noninvasive and effective treatment for PONV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lavender Aromatherapy | Experimental | Procedure: Lavender AromatherapyAromatherapy with lavender essential oil. |
| Rose Aromatherapy | Experimental | Procedure: Rose AromatherapyAromatherapy with rose essential oil |
| Ginger Aromatherapy | Experimental | Procedure: Ginger AromatherapyAromatherapy with ginger essential oil |
| Placebo Aromatherapy | Placebo comparator | Procedure: Placebo AromatherapyAromatherapy with pure water |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be scheduled for elective surgery
- Have a postoperative nausea and vomiting
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavender AromatherapyAlso: Aromatherapy with lavender essential oilthe two drops of lavender essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes. | Procedure or surgery | Lavender Aromatherapy |
| Rose AromatherapyAlso: Aromatherapy with rose essential oilthe two drops of rose essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes. | Procedure or surgery | Rose Aromatherapy |
| Ginger AromatherapyAlso: Aromatherapy with ginger essential oilthe two drops of ginger essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes. | Procedure or surgery | Ginger Aromatherapy |
| Placebo AromatherapyAlso: Aromatherapy with pure waterthe two drops of pure water will be dropped into the gauze and the patient will inhale it for 5 minutes | Procedure or surgery | Placebo Aromatherapy |
Primary outcome
The change of the nausea scores
Time frame: During postoperative 24 hours
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)
The change of the vomiting score
Time frame: During postoperative 24 hours
Vomiting will be measured with verbal descriptive scale (0=no vomiting, 1= 1 time, 2= 2 or 3 times, 3= 4 times and up)
1 secondary outcome
The consumption of the antiemetic drug
Time frame: During postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Nausea and Vomiting
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Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tugba Karaman, MD principal investigator
Gaziosmanpasa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender Aromatherapy, Rose Aromatherapy and Ginger Aromatherapy in people with Postoperative Nausea and Vomiting, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of the nausea scores (time frame: During postoperative 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.