The Effect of Cold Vapor on Nausea and Vomiting in the Early Postoperative Period After Laparoscopic Cholecystectomy
NCT ID: NCT05302128
Last Updated: 2022-04-04
Study Results
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Basic Information
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UNKNOWN
NA
84 participants
INTERVENTIONAL
2022-04-11
2022-11-01
Brief Summary
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Detailed Description
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In a meta-analysis study that included data from eleven countries, the prevalence of PONV was 27.7%, the prevalence of postoperative nausea was 31.4% and the prevalence of post-operative vomiting was 16.8%. In a study conducted in Turkey, it was reported that 45.9% of surgical patients had nausea and 23.6% had vomiting in the postoperative period. In another study conducted in the postoperative recovery unit, it was reported that 29% of the patients experienced nausea and vomiting.
The risk of PONV may vary depending on the patient, anesthesia, and surgical intervention. Patient-related risk factors include female gender, young age (under 50 years of age), obesity, history of motion sickness; anesthesia-related risk factors include the type of anesthesia, duration of administration, use of volatile anesthetics, opioids, and nitrous oxide; Among the risk factors for previous surgical interventions are laparoscopic, bariatric, gynecological and cholecystectomy surgeries.
Pharmacological treatment, non-pharmacological treatment methods, or both are used in the management of PONV in patients undergoing surgical intervention. Today, a multimodal approach is recommended in the management of PONV in early recovery protocols in surgical patients. Antiemetic drugs used among pharmacological methods can cause side effects such as headache, constipation, drowsiness, tremor, irregular heartbeat, and wound infection. Therefore, non-pharmacological treatment methods have an important place in care practices. In the literature, there are many studies on the successful application of non-pharmacological treatment methods such as massage, progressive relaxation exercises, hypnosis, acupuncture, yoga, acupressure, transcutaneous electrical nerve stimulation, music therapy, herbal treatments, and aromatherapy in the prevention of PONV.
The cold application creates vasoconstriction in the vessels in the area where it is applied, decreases the metabolic rate, and reduces edema. The cold application reduces muscle temperature by reducing the tension sensitivity of muscle spindles with the reflex effect of heat receptors or inactivating trigger points in the muscles and helps to reduce muscle spasm. Thus, it reduces skin sensitivity by lowering the temperature of nerve fibers and receptors. Cold application is especially beneficial in post-traumatic pain, swelling, and muscle spasm. Temperature can affect the release of odorous volatile substances in drugs. The cold application also has clinically important potential effects on nausea caused by unpleasant tastes by reducing the olfactory component of negative aromas. Cold can be applied in different ways. One of them is administration by inhalation. In the literature, there are studies on the positive effects of cold vapor application on sore throat, cough, swallowing, and hoarseness. In a study, it was determined that postoperative nausea and vomiting were less in patients who received oral care with the cold application after laparoscopic myomectomy compared to the control group. There is no study in the literature examining the effect of cold vapor application on PONV.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Cold vapor group
Cold vapor will be applied to the experimental group patients for 15 minutes in the recovery room. For the study, Nebtime UN600A Ultrasonic Nebulizer Device will be used to apply cold steam to the patients which used in the hospital and calibrated (https://elmaslarmedikal.com.tr/urunler/nebtime-un600aultrasonik-nebulizator/). The parameters to be set on the device for the cold vapor to be applied to the patients in the early postoperative period will be vapor intensity level 5 (1-10), air blowing intensity 5 (1-10), heater intensity 1 (+10C), and timer 15 minutes. The patients will be evaluated by the researchers in terms of nausea and vomiting before and 15 minutes after the cold vapor application in the recovery room and at the 2nd, 6th, 12th, and 24th hours after the cold vapor application in the postoperative service.
Cold vapor
Before surgery, the socio-demographic data of the patients will be recorded. After surgery, patients will be evaluated in the recovery room for their suitability to participate in the study with the Ramsay sedation scale and the Modified Aldrete Scale. Cold vapor will be applied to the patients for 15 minutes in the recovery room during the postoperative period. The parameters to be set on the device for the cold vapor to be applied to the patients in the early postoperative period will be vapor intensity level 5, air blowing intensity 5, heater intensity 1 (+10C), and timer 15 minutes. The patients will be evaluated by the researchers in terms of nausea and vomiting before and 15 minutes after the cold vapor application in the recovery room and at the 2nd, 6th,12th, and 24th hours after the cold vapor application in the postoperative service.
Control group
Patients in the control group will receive standard care that includes all medical and non-medical treatments in the hospital. Nursing care, which is routinely applied to patients in the postoperative period, both in the recovery room and in the service, will be continued within the standard care. The patients will be evaluated by the researchers in terms of nausea and vomiting when they come to the recovery room and at the 2nd, 6th,12th, and 24th hours after the surgery in the postoperative service.
No interventions assigned to this group
Interventions
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Cold vapor
Before surgery, the socio-demographic data of the patients will be recorded. After surgery, patients will be evaluated in the recovery room for their suitability to participate in the study with the Ramsay sedation scale and the Modified Aldrete Scale. Cold vapor will be applied to the patients for 15 minutes in the recovery room during the postoperative period. The parameters to be set on the device for the cold vapor to be applied to the patients in the early postoperative period will be vapor intensity level 5, air blowing intensity 5, heater intensity 1 (+10C), and timer 15 minutes. The patients will be evaluated by the researchers in terms of nausea and vomiting before and 15 minutes after the cold vapor application in the recovery room and at the 2nd, 6th,12th, and 24th hours after the cold vapor application in the postoperative service.
Eligibility Criteria
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Inclusion Criteria
* To undergo laparoscopic cholecystectomy
* Having an ASA score of 1-2
* Getting 2 points from the Ramsay Sedation Scale in the postoperative recovery room.
* Having a Modified Aldrete score of at least 9 in the postoperative recovery room
* To be willing to participate in the study.
Exclusion Criteria
* Being under the age of 18
* Having an ASA score of 3 and above
* Not agreeing to participate in the study.
18 Years
ALL
No
Sponsors
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Atlas University
OTHER
Istanbul Medeniyet University
OTHER
Responsible Party
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Dr. Özlem İbrahimoğlu
Assisstant Professor
Central Contacts
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References
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Related Links
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Aygin, D. (2016). Bulantı ve kusma. Yoğun Bakım Hemşireliği Dergisi, 20(1), 44-56.
Durmaz, M., \& Burucu, R. (2019). Ameliyat Sonrası Bulantı ve Kusmayı Önlemede Kullanılan Farmakolojik Olmayan Yöntemlerin Kanıt Düzeyleri. İzmir Katip Çelebi Üniversitesi Sağlık Bilimleri Fakültesi Dergisi, 4(3), 97-104.
Hepkarşı, A., Bor, C., Demirağ, K., Çankayalı, İ., Uyar, M. (2015). Yoğun Bakım Sedasyonunda Ramsay-Richmond Skalaları ve Hemşire-Doktor Arasındaki Uyumun Karşılaştırılması. J Turk Soc Intens Care,13,112-6 doi: 10.4274/tybdd.20592
Irmak, B., \& Karadağ, M. Ameliyat sonrası bulantı ve kusmanın yönetiminde aromaterapinin etkisini değerlendiren çalışmaların incelenmesi. Cerrahi Ameliyathane Sterilizasyon Enfeksiyon Kontrol Hemşireliği Dergisi, 2(1), 11-30.
Jung, M. Y., Choi, H. S., \& Park, K. Y. (2012). Effects of Postoperative Oral Care Using Cold Therapy on Nausea, Vomiting and Oral Discomfort in Patients with Laparoscopic Myomectomy. Journal of Korean Academy of Fundamentals of Nursing, 19(3), 292-301.
Sözen, K. K. (2020). Ameliyat sonrası derlenme ünitesinde görülen erken dönem komplikasyonlarının değerlendirilmesi. Çukurova Anestezi ve Cerrahi Bilimler Dergisi, 3(3), 212-222.
Yaman Aktaş, Y., Gürçayır, D., \& Atalay, C. (2018). Ameliyat sonrası bulantı kusma yönetiminde kanıta dayalı uygulamalar. Dicle Tıp Dergisi, 45(3), 341-351.
Zaman, F., \& Karahan, E. (2020). The Effect of Cold Vapor Treated to Thyroidectomy Patients During Early Postoperative Period. Eastern Journal of Medicine, 25(1), 118-125.
Other Identifiers
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IstanbulMU12
Identifier Type: -
Identifier Source: org_study_id
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