Clinical trial NCT05522023: Effects of Aromatic Solution Applied After Surgery
Official title: The Effect of Aromatic Solution Applied After Percutaneous Nephrolithotomy Surgery on Sore Throat, Thirst and Nausea-Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 group randomized
Primary purpose: PREVENTION

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.

Detailed description: Intubation-based pharyngeal traumas are common in patients undergoing general anesthesia among the causes of post-operative sore throat and thirst symptoms. In the literature, it is reported that sore throat is frequently seen after endotracheal intubation (14.4% to 100%) and is one of the complications that patients fear most. Since sore throat and thirst can cause swallowing and breathing difficulties in the postoperative period, this affects the patient's nutrition and fluid intake and may prolong the recovery period. Also these are; creates a physical stress source, increases postoperative morbidity and reduces patient satisfaction. As pharmacological methods for relieving sore throat and thirst, it is recommended to use steroids and local anesthetics in the form of mouth washes and sprays. As non-pharmacological methods, it has been determined that aromatherapy, especially lavender, is effective in preventing and reducing sore throat and thirst. It has been determined that lavender has functions that reduce throat irritation, hoarseness, pain and stress among aromatic plants.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Nonpharmacological method effects (Sore Throat)
timeFrame: postoperative first day
measure: Nonpharmacological method effects (Thirst)
timeFrame: postoperative first day
measure: Nonpharmacological method effects (Nausea and Vomiting)
timeFrame: postoperative first day
Secondary outcomes:
measure: Nonpharmacological method effects (Sore Throat)
timeFrame: postoperative first day
measure: Nonpharmacological method effects (Thirst)
timeFrame: postoperative first day
measure: Nonpharmacological method effects (Nausea and Vomiting)
timeFrame: postoperative first day
Other outcomes:
Locations:
city: Sarıçam
country: Turkey
facility: Cukurova University
state: Adana
Study officials:
affiliation: Gaziosmanpaşa University Department of Anesthesiology and Reanimation
name: Mustafa Süren, Phd Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.