The Effect of Ginger and Peppermint on Postoperative Nausea and Vomiting in Patients After Thyroid Surgery

NCT04874298 | Unknown DMC

• 1 other identifier: 2020-8-1
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The study was planned as a randomized controlled experimental study to determine the effect of inhalation use of ginger and peppermint on postoperative nausea and vomiting in patients undergoing thyroidectomy surgery. After the approval of the ethics committee and institutional permission, 81 patients who applied to the general surgery clinic for thyroidectomy between 1 December 2020 and 1 December 2021 and met the inclusion criteria will be included in the study. Within the scope of the planned study, the sample size in the light of the reported academic studies was determined as effect size d = 0.40 (effect size), α = 0.05 (margin of error), 1-β = 0.90 (Power) and by using the G-power package program with the specified criteria. It was decided to recruit 81 people (27 people per 3 group). Block randomization method will be used to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program (https://www.randomizer.org/) will be used. Randomization will be done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list. Before the operation, the patient will be visited and information will be given about the purpose, content and intervention to be applied. After obtaining verbal and written permission from the patients who accepted to participate in the study, the "Informed Consent" will be filled in the "Patient Identification form. On the day of surgery, "surgical intervention information will be filled in by the researcher. In the postoperative period at the 2nd, 4th, 6th, 12th and 24th hours, the patient will use ginger and peppermint oil as inhalation. At the end of the 24th hour, the application will be terminated. In the control group, no application will be made during and after the surgical intervention, and routine treatment and care will be applied. After admission to the clinic of the patients in the experimental and control groups, the severity of pain, nausea and vomiting, the number of nausea-vomiting at the 2nd, 6th, 12th and 24th hours, the name, dose, frequency and time of the antiemetic drugs used were determined by the researcher. At the end of the 24th hour, Rhodes Nausea Vomiting Index score will be evaluated by the researcher.

Conditions

Postoperative Nausea and Vomiting

Keywords

Nausea, Vomiting, Postoperative Nausea and Vomiting, Ginger, Peppermint, Thyroid surgery, Nursing

Outcome Measures

Primary Outcomes (5)

• Postoperative pain severity

  Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain

  Reported pain severity in the first 24 hours after surgery

• The number of postoperative nausea, vomiting and retching

  The number of nausea, vomiting

  Reported the number of nausea, vomiting and retching in the first 24 hours after surgery

• Postoperative nausea and vomiting severity

  Nausea and vomiting severity with Visual Assessment Scale (VAS) Score: 0-10; 0- None, 10- Agonizing

  Reported nausea and vomiting severity in the first 24 hours after surgery

• Use of antiemetics

  The name, dose, frequency and time of the antiemetic drugs

  In the first 24 hours after surgery

• Rhodes Nausea Vomiting Index score

  Evaluation of Rhodes Nausea Vomiting Index score In order to score the scale, responses to items 1, 3, 6 and 7 are calculated in reverse order; For each answer, they are scored as 0: minimum, 4: most discomfort, and the score obtained from 8 items is added. It is expressed as 32 points, the highest possible value.

  At the end of the 24th hour after surgery

Secondary Outcomes (1)

• Postoperative complications

  End of surgery to hospital discharge 2-3 days

Study Arms (3)

Intervention Arm 1 (Ginger Group)

EXPERIMENTAL

Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental group. In the postoperative period at the 2nd, 4th, 6th, 12th and 24th hours, the patient will use ginger oil as inhalation. The structure of the inhaler tube is explained. The back cover of the inhaler tube is opened and absorbent cotton swab is inserted into it. Cotton swab 1 ml of essential oil is added by dropping on it. The back cover of the inhaler tube is closed. It is waited for 10-15 minutes. The front cover of the inhaler tube is opened at the time intervals specified in the study procedure (at the 2nd, 4th, 6th, 12th and 24th hours after the operation, and the patient is allowed to smell essential oil from the tube. With the end of the sniffing process, the front cover of the tube is closed and the essential oil remains in the tube. The essential oil tubes to be applied will be prepared separately for each patient and that day.

Other: Ginger

Intervention Arm 2 (Peppermint Group)

EXPERIMENTAL

Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental group. In the postoperative period at the 2nd, 4th, 6th, 12th and 24th hours, the patient will use Peppermint oil as inhalation. The structure of the inhaler tube is explained. The back cover of the inhaler tube is opened and absorbent cotton swab is inserted into it. Cotton swab 1 ml of essential oil is added by dropping on it. The back cover of the inhaler tube is closed. It is waited for 10-15 minutes. The front cover of the inhaler tube is opened at the time intervals specified in the study procedure (at the 2nd, 4th, 6th, 12th and 24th hours after the operation, and the patient is allowed to smell essential oil from the tube. With the end of the sniffing process, the front cover of the tube is closed and the essential oil remains in the tube. The essential oil tubes to be applied will be prepared separately for each patient and that day.

Other: Peppermint

Control Arm

NO INTERVENTION

In the control group, no application will be made during and after the surgical intervention, and routine treatment and care will be applied.

Interventions

Ginger OTHER

Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental group. In the postoperative period at the 2nd, 4th, 6th, 12th and 24th hours, the patient will use Ginger and Peppermint oil as inhalation. The structure of the inhaler tube is explained. The back cover of the inhaler tube is opened and absorbent cotton swab is inserted into it. Cotton swab 1 ml of essential oil is added by dropping on it. The back cover of the inhaler tube is closed. It is waited for 10-15 minutes. The front cover of the inhaler tube is opened at the time intervals specified in the study procedure (at the 2nd, 4th, 6th, 12th and 24th hours after the operation, and the patient is allowed to smell essential oil from the tube. With the end of the sniffing process, the front cover of the tube is closed and the essential oil remains in the tube. The essential oil tubes to be applied will be prepared separately for each patient and that day.

Intervention Arm 1 (Ginger Group)

Peppermint OTHER

Peppermint

Intervention Arm 2 (Peppermint Group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who are 18 years old or older,
• According to the American Association of Anesthesiologists (ASA) classification; ASA score I and II,
• Not known ginger and peppermint allergy,
• Patients who are qualified to understand and answer questions in terms of cognitive capacity,
• Patients without any psychiatric disorder,
• Patients who agree to participate in the study will be included in the study.

You may not qualify if:

• Under 18 years old,
• Those with nutritional disorders,
• Patients who require additional treatment to prevent nausea and vomiting, or patients using non-prescription anti-nausea and other complementary therapy,
• Patients with peppermint and ginger allergy,
• Those who have additional diseases (gastrointestinal system diseases, central nervous system tumors, vertigo etc.) that may affect the state of nausea and vomiting,
• Not agreeing to participate in the research,
• Those with respiratory diseases such as asthma, COPD, etc.

Sponsors & Collaborators

• Sona PASHAEI: lead

Study Sites (1)

IU-Cerrahpaşa Florence Nightingale Faculty of Nursing Department of Surgical Nursing Abide-i Hürriyet street. 34381 Sisli - Istanbul

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Interventions

ginger extract; peppermint oil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Yeliz E Ersoy, Prof.Dr

  Bezmialem University

  PRINCIPAL INVESTIGATOR

• Nuray AKYUZ, Dr

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

• Sona PASHAEI, MSC

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Central Study Contacts

Sona PASHAEI, MSC

CONTACT

+905374869720; sona.pashaei@ogr.iu.edu.tr

Nuray AKYUZ, Dr

CONTACT

+905326256188; nakyuz1@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: A randomized controlled experimental study to determine the effect of ginger and peppermint after thyroid surgery on postoperative nausea and vomiting

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 5, 2021
• Study Start: March 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)