Effects of Aromatic Solution Applied After Surgery

NCT05522023 | Completed DMC

• 1 other identifier: 466455
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Today, surgical applications are used to solve many health problems. In order for the surgical intervention to take place, anesthesia applications are often required. Complications such as sore throat, thirst and nausea and vomiting may occur as a result of trauma, local irritation and inflammation of the airway mucosa during anesthesia and tracheal intubation. These complications are in the postoperative period; It may cause delayed oral fluid intake, prolonged dehydration, oral odour, and increased risk of aspiration, hematoma and wound dehiscence due to retching and vomiting, all of which may lead to delayed discharge and increased cost. Aromatherapy, one of the non-pharmacological applications, is frequently applied in reducing postoperative complications and its effectiveness is stated. In this study, the aromatic solution applied after the surgery; It was planned to examine the effect on sore throat, thirst, nausea-vomiting. In addition, the multimodal synergistic effect of lavender oil and ginger oil used in the aromatic solution to be prepared will be utilized. As a result of this study, the effectiveness of the aromatic solution application to be applied to the patients in the postoperative period and the benefits and benefits of the patient's recovery process will be determined. Thus, effective application can be made for the entire postoperative period. It is thought that this study to be conducted will be a guide for future studies on the patient group.

Conditions

Surgery; Nurse's Role; Throat, Sore; Thirst; Nausea and Vomiting, Postoperative

Keywords

surgical nursing; complementary alternative medicine; non-pharmacological applications; post-operative care; aromatherapy; sore throat; thirst; nausea vomiting

Outcome Measures

Primary Outcomes (3)

• Nonpharmacological method effects (Sore Throat)

  Visual assessment scale (VAS) will be used to measure sore throat in the study. In this method, the person will be told that there are two endpoints from 1 to 10 that indicate whether they have a sore throat and that they should mark anywhere between these points. It is a scale evaluated by patients by making signs on a 10 cm or 100 mm horizontal or vertical line (or horizontal line with numbers from 1 to 10), with one end indicating that the patient is very well and the other end is indicating that the patient is very bad. VAS measurement will be performed 0, 2, 4, 6 and 8 hours after the patients are transferred from the anesthesia recovery unit to the clinic where they normally lie down after the surgery and are placed in their beds. The experiment will be applied to the placebo and control groups.

  postoperative first day

• Nonpharmacological method effects (Thirst)

  Visual assessment scale (VAS) will be used to measure thirst in the study. In this method, the person will be explained that there are two endpoints from 1 to 10 that indicate whether they have a sore throat and that they should mark anywhere between these points. It is a scale that is evaluated by the patients by making markings on a 10 cm or 100 mm horizontal or vertical line (or horizontal line with numbers from 1 to 10), with one end indicating that the patient is very good the other end is very bad. VAS measurement will be performed at 0, 2, 4, 6, and 8 hours after the patients are transferred from the anesthesia resting unit to the clinic where they are normally hospitalized after the surgery and are placed in their beds. The experiment will be applied to the placebo and control groups.

  postoperative first day

• Nonpharmacological method effects (Nausea and Vomiting)

  In the measurement of nausea-vomiting, a five-stage verbal descriptive scale (VDS) will be applied postoperatively (None: 0, mild nausea: 1, moderate nausea and vomiting: 2, frequent vomiting: 3, severe vomiting: 4). VDS will be measured at 0, 2, 4, 6 and 8 hours after the patients are transferred from the anesthesia resting unit to the clinic where they normally lie down after the surgery and are placed in their beds. The experiment will be applied to the placebo and control groups.

  postoperative first day

Secondary Outcomes (3)

• Nonpharmacological method effects (Sore Throat)

  postoperative first day

• Nonpharmacological method effects (Thirst)

  postoperative first day

• Nonpharmacological method effects (Nausea and Vomiting)

  postoperative first day

Study Arms (3)

Experimental group (group treated with aromatic solution)

EXPERIMENTAL

Informed consent form will be signed by the patients selected by randomization and a personal information form will be filled. Hour 0: The patients will be completely awakened from the anesthesia resting unit, their vital signs will be stable, they will be transferred to the clinic where they lie normally with a 15 glaskow scale, the bed head will be elevated 45 degrees and the risk of aspiration will be ruled out. After controlling the vital signs of the patient, sore throat and thirst with VAS and nausea and vomiting with the verbal descriptive scale VDS will be evaluated. After the data are collected, the aromatic solution will be shaken and applied to the oral cavity and throat as a spray 4 times. After the aromatic solution application is finished, the patients' sore throat, thirst and nausea and vomiting will be re-evaluated with the same forms. 2., 4., 6. The same procedures will be repeated in the 8th and 8th hours.

Procedure: group treated with aromatic solution

Placebo group (group treated with drinking water)

PLACEBO COMPARATOR

Patients included in this group as a result of randomization will have to sign an informed consent form and fill out a personal information form. Hour 0: The patients will be completely awakened from the anesthesia resting unit, their vital signs will be stable, they will be transferred to the clinic where they sleep normally with a 15 glaskow scale, the bed head will be elevated 45 degrees and the risk of aspiration will be ruled out. Nausea and vomiting will be evaluated with a verbal descriptive scale. After the data are collected, drinking water will be applied to the oral cavity and throat in the form of a spray 4 times. After the drinking water application is finished, the patients' sore throat, thirst and nausea and vomiting will be re-evaluated with the same forms. 2., 4., 6. The same procedures will be repeated in the 8th and 8th hours.

Procedure: group treated with drinking water

Control Group

NO INTERVENTION

Patients in the control group were planned to be followed according to their clinical procedures. Since there were no procedures or interventions in the clinical procedures, it was decided to follow up only the patient, and the control group patients to be followed up at the same times with the same forms. Patients included in this group as a result of randomization will have to sign an informed consent form and fill out a personal information form. Hour 0: Patients will be transferred from the recovery unit to the clinic. After controlling the vital signs of the patient, sore throat and thirst with VAS and nausea and vomiting with a verbal descriptive scale will be evaluated. 2., 4., 6. The same procedures will be repeated in the 8th and 8th hours.

Interventions

group treated with aromatic solution PROCEDURE

The aromatic solution applied in the experimental group will be obtained by mixing lavender oil and ginger oil into cold drinking water. For this, lavender and ginger oil approved by the Ministry of Agriculture will be used. 3 drops of lavender oil and 3 drops of ginger oil will be mixed into each 100 ml of drinking water, and it will be applied by spraying 4 times in the oral cavity and throat by shaking to ensure homogeneous distribution before each use. The aromatic solution to be applied in the study will be applied with spray bottles with mouth caps and caps that will be specially provided for each patient.

Experimental group (group treated with aromatic solution)

group treated with drinking water PROCEDURE

In the placebo group, drinking water will be sprayed 4 times in the oral cavity and throat of the patients after the surgery. The aromatic solution to be applied in the study will be applied with spray bottles with mouth caps and caps that will be specially provided for each patient.

Placebo group (group treated with drinking water)

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Accepting the research
• Elective surgery planned with general anesthesia
• Patients in Asa I, II and III classes
• No hearing problem
• No history of allergies to lavender and ginger
• One-time intubation and no difficult intubation
• Those who have no previous psychiatric or mental illness will be included.

You may not qualify if:

• Did not accept the research
• In addition to clinical routine medical treatment, extra drug administration
• Patients with suspected aspiration risk will be excluded.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Sarıçam, Adana, Turkey (Türkiye)

Location

Related Publications (13)

• Chinachoti T, Pojai S, Sooksri N, Rungjindamai C. Risk Factors of Post-operative Sore Throat and Hoarseness. J Med Assoc Thai. 2017 Apr;100(4):463-8.

  PMID: 29911921 BACKGROUND

• Agarwal A, Gupta D, Yadav G, Goyal P, Singh PK, Singh U. An evaluation of the efficacy of licorice gargle for attenuating postoperative sore throat: a prospective, randomized, single-blind study. Anesth Analg. 2009 Jul;109(1):77-81. doi: 10.1213/ane.0b013e3181a6ad47.

  PMID: 19535697 BACKGROUND

• Ahmed A, Abbasi S, Ghafoor HB, Ishaq M. Postoperative sore throat after elective surgical procedures. J Ayub Med Coll Abbottabad. 2007 Apr-Jun;19(2):12-4.

  PMID: 18183710 BACKGROUND

• Shrestha S , Maharjan B , Karmacharya RM . Incidence and Associated Risk Factors of Postoperative Sore Throat in Tertiary Care Hospital. Kathmandu Univ Med J (KUMJ). 2017 Jan.-Mar.;15(57):10-13.

  PMID: 29446355 BACKGROUND

• Lee JY, Sim WS, Kim ES, Lee SM, Kim DK, Na YR, Park D, Park HJ. Incidence and risk factors of postoperative sore throat after endotracheal intubation in Korean patients. J Int Med Res. 2017 Apr;45(2):744-752. doi: 10.1177/0300060516687227. Epub 2017 Feb 7.

  PMID: 28173712 BACKGROUND

• Tazeh-Kand NF, Eslami B, Mohammadian K. Inhaled fluticasone propionate reduces postoperative sore throat, cough, and hoarseness. Anesth Analg. 2010 Oct;111(4):895-8. doi: 10.1213/ANE.0b013e3181c8a5a2. Epub 2010 Mar 17.

  PMID: 20237046 BACKGROUND

• Soltani R, Soheilipour S, Hajhashemi V, Asghari G, Bagheri M, Molavi M. Evaluation of the effect of aromatherapy with lavender essential oil on post-tonsillectomy pain in pediatric patients: a randomized controlled trial. Int J Pediatr Otorhinolaryngol. 2013 Sep;77(9):1579-81. doi: 10.1016/j.ijporl.2013.07.014. Epub 2013 Aug 8.

  PMID: 23932834 BACKGROUND

• Smith HS, Smith EJ, Smith BR. Postoperative nausea and vomiting. Ann Palliat Med. 2012 Jul;1(2):94-102. doi: 10.3978/j.issn.2224-5820.2012.07.05.

  PMID: 25841469 BACKGROUND

• American Society of PeriAnesthesia Nurses PONV/PDNV Strategic Work Team. ASPAN'S evidence-based clinical practice guideline for the prevention and/or management of PONV/PDNV. J Perianesth Nurs. 2006 Aug;21(4):230-50. doi: 10.1016/j.jopan.2006.06.003. No abstract available.

  PMID: 16935735 BACKGROUND

• Oh KE, Song AR, Sok SR. Effects of Aroma Gargling, Cold Water Gargling, and Wet Gauze Application on Thirst, Halitosis, and Sore Throat of Patients After Spine Surgery. Holist Nurs Pract. 2017 Jul/Aug;31(4):253-259. doi: 10.1097/HNP.0000000000000219.

  PMID: 28609410 BACKGROUND

• Sedigh Maroufi S, Moradimajd P, Moosavi SAA, Imani F, Samaee H, Oguz M. Dose Ginger Have Preventative Effects on PONV-Related Eye Surgery? A Clinical Trial. Anesth Pain Med. 2019 Oct 22;9(5):e92072. doi: 10.5812/aapm.92072. eCollection 2019 Oct.

  PMID: 31903330 BACKGROUND

• Fearrington MA, Qualls BW, Carey MG. Essential Oils to Reduce Postoperative Nausea and Vomiting. J Perianesth Nurs. 2019 Oct;34(5):1047-1053. doi: 10.1016/j.jopan.2019.01.010. Epub 2019 May 27.

  PMID: 31147268 BACKGROUND

• Gokce E, Yurtseven S, Arslan S, Suren M, Akdogan N. The effect of an aromatic solution applied after percutaneous nephrolithotomy on sore throat, thirst, and nausea-vomiting: A randomised controlled trial. Complement Ther Clin Pract. 2025 Feb;58:101934. doi: 10.1016/j.ctcp.2024.101934. Epub 2024 Dec 6.

  PMID: 39644858 DERIVED

MeSH Terms

Conditions

Pharyngitis; Postoperative Nausea and Vomiting

Interventions

Drinking Water

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mustafa Süren, Phd Prof

  Gaziosmanpaşa University Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (MSc)

Model Details: 3 group randomized

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 30, 2022
• Study Start: February 15, 2021
• Primary Completion: May 15, 2023
• Study Completion: August 29, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)