## Protocol Section
### Identification Module
**NCT ID:** NCT02732379

**Brief Title:** Effect of Aromatherapy on Postoperative Nausea, Vomiting

**Official Title:** Evaluating the Efficacy of Aromatherapy on Postoperative Nausea, Vomiting

#### Organization Study ID Info
**ID:** PONV
#### Organization
**Class:** OTHER
**Full Name:** Tokat Gaziosmanpasa University
### Status Module
#### Completion Date
**Date:** 2018-11-14

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-12-04

**Type:** ACTUAL

**Last Update Submit Date:** 2018-12-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-11-13

**Type:** ACTUAL

#### Start Date
**Date:** 2016-04

**Status Verified Date:** 2018-12

#### Study First Post Date
**Date:** 2016-04-08
**Type:** ESTIMATED
**Study First Submit Date:** 2016-03-30
**Study First Submit QC Date:** 2016-04-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tokat Gaziosmanpasa University

#### Responsible Party

**Investigator Affiliation:** Tokat Gaziosmanpasa University

**Investigator Full Name:** Tuğba Karaman

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

**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 Module

**Conditions:**

- Postoperative Nausea and Vomiting

**Keywords:**

- Postoperative Nausea and Vomiting

- Aromatherapy

- Quality of Health Care

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 184

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Aromatherapy with lavender essential oil.

**Intervention Names:**

- Procedure: Lavender Aromatherapy

**Label:** Lavender Aromatherapy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Aromatherapy with rose essential oil

**Intervention Names:**

- Procedure: Rose Aromatherapy

**Label:** Rose Aromatherapy

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Aromatherapy with ginger essential oil

**Intervention Names:**

- Procedure: Ginger Aromatherapy

**Label:** Ginger Aromatherapy

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Aromatherapy with pure water

**Intervention Names:**

- Procedure: Placebo Aromatherapy

**Label:** Placebo Aromatherapy

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lavender Aromatherapy

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

**Name:** Lavender Aromatherapy

**Other Names:**

- Aromatherapy with lavender essential oil

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Rose Aromatherapy

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

**Name:** Rose Aromatherapy

**Other Names:**

- Aromatherapy with rose essential oil

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- Ginger Aromatherapy

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

**Name:** Ginger Aromatherapy

**Other Names:**

- Aromatherapy with ginger essential oil

**Type:** PROCEDURE

#### Intervention 4

**Arm Group Labels:**

- Placebo Aromatherapy

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

**Name:** Placebo Aromatherapy

**Other Names:**

- Aromatherapy with pure water

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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)

**Measure:** The change of the nausea scores

**Time Frame:** During postoperative 24 hours

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

**Measure:** The change of the vomiting score

**Time Frame:** During postoperative 24 hours

#### Secondary Outcomes

**Description:** The antiemetic drug dose will be recorded

**Measure:** The consumption of the antiemetic drug

**Time Frame:** During postoperative 24 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria :

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

Exclusion Criteria:

* 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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tokat

**Country:** Turkey

**Facility:** Gaziosmanpasa University Medical School Hospital

**Zip:** 60100

#### Overall Officials

**Official 1:**

**Affiliation:** Gaziosmanpasa University

**Name:** Tugba Karaman, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012817

- Term: Signs and Symptoms, Digestive

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12273

- Name: Nausea

- Relevance: HIGH

- As Found: Nausea

- ID: M17582

- Name: Vomiting

- Relevance: HIGH

- As Found: Vomiting

- ID: M22074

- Name: Postoperative Nausea and Vomiting

- Relevance: HIGH

- As Found: Postoperative Nausea

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009325

- Term: Nausea

- ID: D000014839

- Term: Vomiting

- ID: D000020250

- Term: Postoperative Nausea and Vomiting

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T166

- Name: Ginger

- Relevance: HIGH

- As Found: Exertion

- ID: T141

- Name: English Lavender

- Relevance: HIGH

- As Found: Termination

### Misc Info Module

- Version Holder: 2024-05-24
