Study Results
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Basic Information
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COMPLETED
NA
105 participants
INTERVENTIONAL
2021-02-15
2023-08-29
Brief Summary
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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.
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Detailed Description
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Postoperative nausea and vomiting (PONC) can be seen in 70-80% of surgical patients, and PONC, which is a side effect of anesthesia, is one of the most common complaints together with pain and thirsty. The American Society of Perianesthesia Nurses (ASPAN; American Society of PeriAnesthesia Nurses) defines POBK as nausea and vomiting seen within the first 24 hours after surgery. Aromatherapy is the most commonly used non-pharmacological alternative in the treatment of POBD. Ginger in aromatherapy applications; It is seen that it has been used effectively on gastrointestinal system diseases (gas remover, antispasmodic, appetite stimulant, aids in digestion and prevents nausea and vomiting) from ancient times all over the world.
Location and Features of the Research:
The study will be applied to individuals who have undergone percutaneous nephrolithotomy (PNL) in the urology clinic of Çukurova University Medical Faculty Balcalı Hospital. The urology clinic is a unit with a total of 36 patient beds, where emergency and elective surgeries are performed, and consists of 1 polyclinic and 1 department.
Universe and Sample:
The population of the study will be the patients who underwent PNL (percutaneous nephrolithotomy) operation in the urology clinic of Çukurova University Faculty of Medicine. The sample of the study will consist of patients who underwent PNL operation, met the inclusion criteria, and voluntarily agreed to participate in the study. The analgesic and antiemetic drugs that are routinely applied in the clinic after the surgery will continue, that is, the routine medical treatment of the patients will be carried out and will not be discontinued.
Data Collection Tools:
Prepared by the researcher in data collection; Informed consent form, personal information form, visual assessment scale (VAS - Visual Analog Scale) for the measurement of postoperative thirst and sore throat, and postoperative verbal descriptive scale (VDS - Verbal Descriptive Scale) will be used to evaluate nausea-vomiting. Statistical analysis of the collected data will be done using a package program called SPSS (IBM SPSS Statistics 24).
Ethical Permission:
Before starting the research, permission was obtained from Çukurova University Faculty of Medicine, Balcalı Hospital, Urology Department and Balcalı Hospital Chief Physician, dated 13.11.2020 and numbered E.137729. The permission of the Traditional and Complementary Medicine Clinical Research Ethics Committee, dated 13.01.2021 and numbered 23, was obtained.
The products to be used in the aromatic solution and the preparation dose rates, approved by the General Directorate of Health Services of the Ministry of Health, IU/Fito/01-03 for the year 2020, Gaziosmanpaşa University Anesthesiology and Reanimation Department Lecturer Prof. Dr. It was determined under the consultancy of Mustafa Süren. In addition, in the urology department where the research will be conducted, mouth spray application is routinely used in cases deemed appropriate for post-operative patients. Therefore, a study was planned to examine the effect of using these solutions during routine clinical practice.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Experimental group (group treated with aromatic solution)
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.
group treated with aromatic solution
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.
Placebo group (group treated with drinking water)
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.
group treated with drinking water
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.
Control Group
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.
No interventions assigned to this group
Interventions
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group treated with aromatic solution
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.
group treated with drinking water
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* In addition to clinical routine medical treatment, extra drug administration
* Patients with suspected aspiration risk will be excluded.
18 Years
88 Years
ALL
Yes
Sponsors
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Cukurova University
OTHER
Responsible Party
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Esma Gökçe
Principal Investigator (MSc)
Principal Investigators
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Mustafa Süren, Phd Prof
Role: PRINCIPAL_INVESTIGATOR
Gaziosmanpaşa University Department of Anesthesiology and Reanimation
Locations
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Cukurova University
Sarıçam, Adana, Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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466455
Identifier Type: -
Identifier Source: org_study_id
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