The Effect of Cold Vapor on Nausea and Vomiting in the Early Postoperative Period After Laparoscopic Cholecystectomy

NCT05302128 | Unknown

• 1 other identifier: IstanbulMU12
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative nausea and vomiting (PONV) was defined by the American Society of PeriAnesthesia Nurses (ASPAN) as nausea and/or vomiting in the first 24 hours after surgery and is among the most common complications after pain in patients undergoing surgery. PONV is divided into three as early, late, and delayed. Nausea-vomiting developing within 2-6 hours after surgery is classified as early, nausea-vomiting developing within 6-24 hours after surgery is classified as delayed, and nausea and/or vomiting developing within the first 24 hours after surgery are classified as delayed PONV. PONV increases the length of stay in the recovery room, delays starting oral intake, causes fluid and electrolyte imbalance, and causes pain, dehydration, delayed wound healing, decreased patient comfort, prolonged hospitalization, and increased cost. Therefore, the prevention and management of nausea and vomiting in the perioperative period in surgical patients are very important.

Conditions

Laparoscopic Cholecystectomy; Postoperative Nausea; Postoperative Vomiting

Keywords

Nausea; Vomiting; Nursing care

Outcome Measures

Primary Outcomes (2)

• Cold vapor

  The Visual Analogue Scale (VAS) of the patients for nausea who underwent cold vapor is decreased compared to those who do not. A score between 0 and 10 is taken from the VAS. It is good that the score from the VAS has decreased.

  First 24 hours after surgery

• Cold vapor

  The Postoperative Nausea and Vomiting Impact Scale of the patients for nausea and vomiting who underwent cold vapor are decreased compared to those who do not. A score between 0 and 6 is taken from the Postoperative Nausea and Vomiting Impact Scale. It is good that the score from the Postoperative Nausea and Vomiting Impact Scale has decreased.

  First 24 hours after surgery

Study Arms (2)

Cold vapor group

EXPERIMENTAL

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.

Other: Cold vapor

Control group

NO INTERVENTION

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.

Interventions

Cold vapor OTHER

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.

Cold vapor group

Eligibility Criteria

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

You may qualify if:

• Being 18 years or older
• 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.

You may not qualify if:

• To undergo emergency surgery
• Being under the age of 18
• Having an ASA score of 3 and above
• Not agreeing to participate in the study.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead
• Atlas University: collaborator

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Related Links

• 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.

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Özlem İbrahimoğlu, PhD

CONTACT

+905436195971; oogutlu@gmail.com

Betül Güven, PhD

CONTACT

+905325283751; betulguwen@hotmail.com

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: Assisstant Professor

Model Details: Patients who were hospitalized for laparoscopic cholecystectomy and met the sample selection criteria will be included in the experimental and control groups by block randomization method using the random numbers table on the computer.

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 31, 2022
• Study Start: April 11, 2022
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-04