The Effect of Cold Steam Application on Nausea and Vomiting

NCT06760871 | Not Yet Recruiting

• 1 other identifier: 358/2024
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to determine the effect of cold vapour applied to patients undergoing laparoscopic abdominal surgery primarily on nausea and vomiting and secondarily on antiemetic requirement, patient satisfaction and thirst. H1: Cold steam application after surgical intervention has a decreasing effect on postoperative nausea. H2: Cold steam application after surgical intervention has a decreasing effect on postoperative vomiting. H3: Cold steam application after surgical intervention reduces the need for antiemetic drugs. H4: Cold steam application after surgical intervention has a satisfactory effect on reducing nausea and vomiting.

Conditions

Nausea and Vomiting, Postoperative

Outcome Measures

Primary Outcomes (1)

• nausea rate

  Nausea rate (%)

  6 months

Secondary Outcomes (1)

• Antiemetic requirement

  6 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients in the experimental group will receive inhaled cold vapour.

Other: nebulised distilled water

Control group

NO INTERVENTION

Patients in the control group will not be intervened within the scope of the study.

Interventions

nebulised distilled water OTHER

After the surgery, the patients will be admitted to the ward and taken to the bed, and their care and treatment will be applied by the nurse. Afterwards, the researcher will apply cold vapour as an inhaler for 15 minutes. For this application, the stand to which the ultrasonic nebuliser device is connected will be positioned close to the patient's bed. 200 ml of distilled water will be placed in the liquid reservoir of the device. The patient will be given a comfortable position and the device will be adjusted so that the steam hose covers the patient's mouth and nose and the patient will be allowed to inhale the steam through the mouth and nose. After the electrical connection of the device is provided, the device will be started and cold steam application will begin. In the 1st hour, inhaler cold water vapour application will be performed for 15 minutes.

Experimental group

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing abdominal surgery under general anaesthesia,
• Admitted to the general surgery ward after surgery,
• Who volunteered to participate in the research,
• No mental disability,
• years of age,
• Literate,
• Accepting random selection,
• without Turkish communication problems,
• No preoperative oncological treatment,
• undergoing elective surgery,
• Postoperatively without a nasogastric catheter,
• with an operation time \<4 hours,
• Laparoscopic surgery performed,
• No postoperative nausea and vomiting or mild/moderate nausea,

You may not qualify if:

• Severe nausea or active vomiting prior to administration,
• Migraine, vertigo, etc. who may experience nausea and vomiting due to vestibular disease, pregnancy,
• COPD, asthma, etc. with respiratory problems,
• Not accepting the application of cold steam,
• Not accepting random selection,
• Those with a history of chemotherapy or radiotherapy before surgery,
• Patients who underwent sudden movement changes (bed change, patient transfer, etc.) during the data collection period (0 to 2nd hour),

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University Hospital

Edirne, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: Patients in the experimental group will receive inhaled cold vapour. Patients in the control group will not be intervened within the scope of the study.

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 7, 2025
• Study Start: January 15, 2025
• Primary Completion: April 15, 2025
• Study Completion: December 30, 2025
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

TU (1)