Local Application/Packing Too ColdNCT05888818
The Effect of Cold Application on Nausea and Vomiting in the Early Postoperative Period
A study testing Cold application in people with Local Application/Packing Too Cold and Patient Satisfaction, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
As a result of the literature review, it has been seen that it has not yet been clarified whether cold application methods are effective on postoperative nausea and vomiting, and academic studies on this subject are needed. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Application/Packing Too Cold, Patient Satisfaction, Postoperative Nausea and Vomiting
- What is being tested?
- Cold application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 30 Oct 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who will undergo elective surgery
- Attempting laparoscopic cholecystectomy
- Those between the ages of 18-65
- Those who will receive general anesthesia
- Not allergic to cold
- Body temperature ≥36°C
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- ASA I and ASA II class
- Those with an Apfel risk score of 2 and above
- Postoperative nausea severity of 2 and above
- Without chronic disease
- Neurological problems
- No problem communicating,• No hearing and vision problems
- Being conscious, awake and oriented after surgery,
- Patients who volunteer to participate in the study will be included in the study
Who cannot join
- Those who are allergic to cold
- Body temperature <36°C,
- Those who have a disability, incision and surgical procedure around the head and neck
- Having chronic illness
- Having neurological problems
- Having nasogastric tube
Show all 9Show fewer
- Postoperatively conscious, awake and not oriented,
- Not eligible for inclusion criteria and
- Patients who do not volunteer to participate in the study will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bulent Ecevit University
Zonguldak, Kozlu, 67100
About this study
Official title: The Effect of Cold Application on Nausea and Vomiting in the Early Postoperative Period - Randomized Controlled Study
As a result of the literature review, it has been seen that it has not yet been clarified whether cold application methods are effective on postoperative nausea and vomiting, and academic studies on this subject are needed.
The aim of the planned study was to conduct a randomized controlled experimental study to evaluate the effect of the cold application method on nausea and vomiting and the need for antiemetic drugs in the early postoperative period.
Read more
The research hypotheses are as follows:
H1:Cold application method reduces nausea and vomiting in the early postoperative period.
H1:The cold application method reduces the need for antiemetic drugs in the early postoperative period.
H1:Cold application method in the early postoperative period increases patient satisfaction.
Condition or disease:
Postoperative nausea and vomiting,Postoperative antiemetic use status,Patient satisfaction,Effects of cold application method
Intervention/treatment:
There is an intervention group in which the cold application method is applied.
Read the detailed description
The aim of the planned study was to conduct a randomized controlled experimental study to evaluate the effect of the cold application method on nausea and vomiting and the need for antiemetic drugs in the early postoperative period.
The population of the study will consist of patients who are planned to undergo laparoscopic cholecystectomy under general anesthesia in the Department of General Surgery, Zonguldak Bülent Ecevit University Health Practice and Research Center between October 2022 and October 2024.Çalışmanın örneklemini laparoskopik kolesistektomi planlanan, dahil edilme kriterlerini karşılayan ve çalışmaya katılmaya gönüllü olan hastalar oluşturacaktır.
As a result of the GPower power analysis, it was calculated that at least 60 people (at least 30 people for each group) who met the inclusion criteria of the research should be taken in order to obtain 80% power at the 95% confidence interval for the d=0.8 effect size.
Data collecting:
The collection of research data will be carried out in three stages.
- stage:Patients scheduled for laparoscopic cholecystectomy who have undergone hospitalization will be evaluated in terms of their eligibility for inclusion criteria, and eligible patients will be invited to participate in the study.The purpose of the research will be explained to the patients, the informed consent form will be read, written and verbal consent will be obtained and a copy of the form will be given to the patients.Then, the patient information data collection form and Apfel risk score will be filled with face-to-face interview technique, and the answers given by the patients will be recorded.
- stage: The surgery will be held in the recovery room.While the patients in the intervention group are in the recovery room after the surgery, their routine applications will be made and the state of consciousness and alertness will be checked.After the application, the presence of nausea, severity, vomiting status, vital signs (blood pressure, pulse, respiratory rate, body temperature) will be measured.Then, a cold application (with a cold gel pack) will be applied to the nape area for 5 minutes.Presence of nausea, severity, vomiting status, vital signs will be re-measured immediately after the application.Antiemetic drug use and opioid drug use will be questioned.
- stage:Presence, severity and presence of nausea will be re-evaluated at the 2nd and 6th hours of the experimental and control group patients.Antiemetic drug use and opioid drug use will be questioned.Patient satisfaction will be evaluated.
- Conditions
- Local Application/Packing Too Cold, Patient Satisfaction, Postoperative Nausea and Vomiting
- Being tested
- Cold application
- Keywords
- Nausea and vomiting after surgery,cold application methods,nursing care after surgery,alternative and complementary methods,postoperative care,cholecystectomy, Patient satisfaction
- Medical subject headings
- Patient Satisfaction, Postoperative Nausea and Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold applicationOther
A cold application (with a cold gel pack) will be applied to the upper part of the neck for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| cold application group | Experimental | A cold application (with a cold gel pack) will be applied to the upper part of the neck for 5 minutes. Receives: Other: Cold application |
| standard treatment | No intervention | No application will be made and the presence of nausea, severity, vomiting and vital signs will be measured after 5 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the mean scores of the experimental and control groups from the nausea numerical scale
Nausea Numerical Scale There are numbers from 0 to 10 on the scale.The scale is explained to the patients and asked to choose the number between 0 and 10 that best reflects their nausea.
Zero usually indicates 'no nausea' while 10 represents 'unbearable nausea'. Evaluation will be made in the recovery room after the surgery, then at the 2nd and 6th hours.
Measured: two year
Determination of patient satisfaction of the experimental and control groups
The patient satisfaction scale is used to evaluate patient satisfaction.It consists of numbers between "0" and "10" to determine the satisfaction level of the patients after the A value of zero indicates "no satisfaction" with the practice, while a value of ten indicates "a lot of satisfaction". Satisfaction scale will be evaluated at the 6th hour after the surgery.
Measured: two year
Antiemetic use status of the groups
The patients' use of antiemetics after surgery will be questioned.
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Oct 2022
- Primary completion30 Jul 2023
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Application/Packing Too ColdStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There is an experimental and a control group.The distribution of the patients to the groups was made according to the random numbers table obtained by using the index formulas and randomly in the excel program in the web environment.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nigar Ak Turkis, Zonguldak Bulent Ecevit University
- Investigators
- Nigar AK TURKİS, PhD student, Principal investigator, Zonguldak Bulent Ecevit University,PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888818
- Sponsor's protocol ID
- 2022/16-08
- Status last verified
- Sep 2026
- First submitted
- 3 May 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Application on Nausea and Vomiting in the Early Postoperative Period - Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05888818
- Acronym / sponsor ID
- 2022/16-08
- Conditions
- Local Application/Packing Too Cold, Patient Satisfaction, Postoperative Nausea and Vomiting
- Keywords
- Nausea and vomiting after surgery,cold application methods,nursing care after surgery,alternative and complementary methods,postoperative care,cholecystectomy, Patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 5 Jun 2023 (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.
As a result of the literature review, it has been seen that it has not yet been clarified whether cold application methods are effective on postoperative nausea and vomiting, and academic studies on this subject are needed.
The aim of the planned study was to conduct a randomized controlled experimental study to evaluate the effect of the cold application method on nausea and vomiting and the need for antiemetic drugs in the early postoperative period.
The research hypotheses are as follows:
H1:Cold application method reduces nausea and vomiting in the early postoperative period.
H1:The cold application method reduces the need for antiemetic drugs in the early postoperative period.
H1:Cold application method in the early postoperative period increases patient satisfaction.
Condition or disease:
Postoperative nausea and vomiting,Postoperative antiemetic use status,Patient satisfaction,Effects of cold application method
Intervention/treatment:
There is an intervention group in which the cold application method is applied.
Detailed description
The aim of the planned study was to conduct a randomized controlled experimental study to evaluate the effect of the cold application method on nausea and vomiting and the need for antiemetic drugs in the early postoperative period.
The population of the study will consist of patients who are planned to undergo laparoscopic cholecystectomy under general anesthesia in the Department of General Surgery, Zonguldak Bülent Ecevit University Health Practice and Research Center between October 2022 and October 2024.Çalışmanın örneklemini laparoskopik kolesistektomi planlanan, dahil edilme kriterlerini karşılayan ve çalışmaya katılmaya gönüllü olan hastalar oluşturacaktır.
As a result of the GPower power analysis, it was calculated that at least 60 people (at least 30 people for each group) who met the inclusion criteria of the research should be taken in order to obtain 80% power at the 95% confidence interval for the d=0.8 effect size.
Data collecting:
The collection of research data will be carried out in three stages.
- stage:Patients scheduled for laparoscopic cholecystectomy who have undergone hospitalization will be evaluated in terms of their eligibility for inclusion criteria, and eligible patients will be invited to participate in the study.The purpose of the research will be explained to the patients, the informed consent form will be read, written and verbal consent will be obtained and a copy of the form will be given to the patients.Then, the patient information data collection form and Apfel risk score will be filled with face-to-face interview technique, and the answers given by the patients will be recorded.
- stage: The surgery will be held in the recovery room.While the patients in the intervention group are in the recovery room after the surgery, their routine applications will be made and the state of consciousness and alertness will be checked.After the application, the presence of nausea, severity, vomiting status, vital signs (blood pressure, pulse, respiratory rate, body temperature) will be measured.Then, a cold application (with a cold gel pack) will be applied to the nape area for 5 minutes.Presence of nausea, severity, vomiting status, vital signs will be re-measured immediately after the application.Antiemetic drug use and opioid drug use will be questioned.
- stage:Presence, severity and presence of nausea will be re-evaluated at the 2nd and 6th hours of the experimental and control group patients.Antiemetic drug use and opioid drug use will be questioned.Patient satisfaction will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- There is an experimental and a control group.The distribution of the patients to the groups was made according to the random numbers table obtained by using the index formulas and randomly in the excel program in the web environment.
| Arm | Type | Receives |
|---|---|---|
| cold application group | Experimental | Other: Cold applicationA cold application (with a cold gel pack) will be applied to the upper part of the neck for 5 minutes. |
| standard treatment | No intervention | –No application will be made and the presence of nausea, severity, vomiting and vital signs will be measured after 5 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Those who will undergo elective surgery
- Attempting laparoscopic cholecystectomy
- Those between the ages of 18-65
- Those who will receive general anesthesia
- Not allergic to cold
Key exclusion criteria (9 listed)
- Those who are allergic to cold
- Body temperature <36°C,
- Those who have a disability, incision and surgical procedure around the head and neck
- Having chronic illness
- Having neurological problems
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 |
|---|---|---|
| Cold applicationA cold application (with a cold gel pack) will be applied to the upper part of the neck for 5 minutes. | Other | cold application group |
Primary outcome
Determining the mean scores of the experimental and control groups from the nausea numerical scale
Time frame: two year
Nausea Numerical Scale There are numbers from 0 to 10 on the scale.The scale is explained to the patients and asked to choose the number between 0 and 10 that best reflects their nausea. Zero usually indicates 'no nausea' while 10 represents 'unbearable nausea'. Evaluation will be made in the recovery room after the surgery, then at the 2nd and 6th hours.
Determination of patient satisfaction of the experimental and control groups
Time frame: two year
The patient satisfaction scale is used to evaluate patient satisfaction.It consists of numbers between "0" and "10" to determine the satisfaction level of the patients after the A value of zero indicates "no satisfaction" with the practice, while a value of ten indicates "a lot of satisfaction". Satisfaction scale will be evaluated at the 6th hour after the surgery.
Antiemetic use status of the groups
Time frame: two year
The patients' use of antiemetics after surgery will be questioned.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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.
Nigar AK TURKİS, PhD student principal investigator
Zonguldak Bulent Ecevit University,PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold application in people with Local Application/Packing Too Cold and Patient Satisfaction, run by Zonguldak Bulent Ecevit 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 14 inclusion and 9 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: finished, as of the sponsor's last update on 9 Sep 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determining the mean scores of the experimental and control groups from the nausea numerical scale (time frame: two year). The study lists 3 primary outcomes in all. 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 9 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.