Nausea and Vomiting, PostoperativeNCT06760871
The Effect of Cold Steam Application on Nausea and Vomiting
A study testing nebulised distilled water in people with Nausea and Vomiting, Postoperative, run by Trakya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Nausea and Vomiting, Postoperative
- What is being tested?
- nebulised distilled water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing abdominal surgery under general anaesthesia,
- Admitted to the general surgery ward after surgery,
- Who volunteered to participate in the research,
- No mental disability,
- 18 years of age,
- Literate,
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- 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,
- Patients with ASA score 1, 2 or 3 were determined as inclusion criteria.
Who cannot join
- 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),
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cold Steam Application on Nausea and Vomiting After Laparoscopic Abdominal Surgery: Randomized Controlled Trial
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.
Read the detailed description
The research will be conducted with the participation of surgical patients who underwent laporoscopic abdominal surgery between December 2024 and March 2025 in the General Surgery Department of Trakya University Hospital.
Effect size of 0.2 was predicted, the smallest possible significant correlation coefficient between repeated measurements was accepted as 0.3, and the minimum number of people to be included in the sample was calculated as 80, consisting of 40 patients from each group with a 95% confidence level, 5% margin of error and 80% power value. In case of possible data loss, drop out rate was accepted as 10% and 44 patients were included in each group.
- Conditions
- Nausea and Vomiting, Postoperative
- Being tested
- nebulised distilled water
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nebulised distilled waterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients in the experimental group will receive inhaled cold vapour. Receives: Other: nebulised distilled water |
| Control group | No intervention | Patients in the control group will not be intervened within the scope of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
nausea rate
Nausea rate (%)
Measured: 6 months
Secondary outcomes (1)
Antiemetic requirement
Antiemetic requirement (Yes/No)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Nov 2025
- Primary completion9 Nov 2025
- Study completion30 Dec 2025 (estimated)
Why it stopped: the researcher cannot collect data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Kızılcık Ozkan, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760871
- Sponsor's protocol ID
- 358/2024
- Status last verified
- Jan 2025
- First submitted
- 17 Dec 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Steam Application on Nausea and Vomiting After Laparoscopic Abdominal Surgery: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06760871
- Acronym / sponsor ID
- 358/2024
- Conditions
- Nausea and Vomiting, Postoperative
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the researcher cannot collect data.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 9 Nov 2025 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research will be conducted with the participation of surgical patients who underwent laporoscopic abdominal surgery between December 2024 and March 2025 in the General Surgery Department of Trakya University Hospital.
Effect size of 0.2 was predicted, the smallest possible significant correlation coefficient between repeated measurements was accepted as 0.3, and the minimum number of people to be included in the sample was calculated as 80, consisting of 40 patients from each group with a 95% confidence level, 5% margin of error and 80% power value. In case of possible data loss, drop out rate was accepted as 10% and 44 patients were included in each group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: nebulised distilled waterPatients in the experimental group will receive inhaled cold vapour. |
| Control group | No intervention | –Patients in the control group will not be intervened within the scope of the study. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Undergoing abdominal surgery under general anaesthesia,
- Admitted to the general surgery ward after surgery,
- Who volunteered to participate in the research,
- No mental disability,
- 18 years of age,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nebulised distilled waterAfter 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. | Other | Experimental group |
Primary outcome
nausea rate
Time frame: 6 months
Nausea rate (%)
1 secondary outcome
Antiemetic requirement
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nebulised distilled water in people with Nausea and Vomiting, Postoperative, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nausea rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.