Obese Patients With Bariatric SurgeryNCT07825779
The Effect of Cold Application on Nausea and Vomiting After Bariatric Surgery
A study testing ICE in people with Obese Patients With Bariatric Surgery, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Obesity is a chronic disease resulting from an excess of body fat mass relative to lean body mass, characterized by a deterioration in the individual's quality of life and health (Kayar and Utku, 2013; Usta and Çavdar, 2013; Tam and Çakır, 2012; Tuncalı et al., 2018). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obese Patients With Bariatric Surgery
- What is being tested?
- ICE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals over the age of 18
- Patients accessible prior to surgery
- Those scheduled to receive general anesthesia only
- Conscious individuals
- Individuals without cognitive or psychiatric disorders
Who cannot join
- Individuals under the age of 18
- Those who experienced serious complications during or after surgery
- Individuals with hearing, visual, speech, or cognitive dysfunction
- Those without neurological problems
- Patients who do not consent to the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Obesity is a chronic disease resulting from an excess of body fat mass relative to lean body mass, characterized by a deterioration in the individual's quality of life and health (Kayar and Utku, 2013; Usta and Çavdar, 2013; Tam and Çakır, 2012; Tuncalı et al., 2018). Bariatric surgery is becoming increasingly common worldwide. Nausea and vomiting are among the most frequently observed complications in these patients. This study will be conducted to assess patients for the risk of nausea and vomiting and to examine the effects of a cold application nursing intervention. The lack of sufficient literature measuring nausea and vomiting in patients following bariatric surgery prompted us to undertake this study.
Read the detailed description
The analysis of the patients' pre- and post-operative scale scores in this study is expected to reveal an improvement in quality of life, consistent with the findings of similar studies. It is anticipated that the patients' quality of life will increase as they achieve their desired weight and body image, gain mobility, and become more independent in their daily lives. Quality of life is defined as the level of satisfaction shaped by an individual's abilities and lifestyle. Obesity frequently impacts quality of life negatively by affecting the individual psychosocially-particularly through dissatisfaction with their physical appearance.
- Conditions
- Obese Patients With Bariatric Surgery
- Being tested
- ICE
- Keywords
- obese patients, nausea and vomiting, cold application
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICEOther
Also called Experimental group subjected to ice application
Upon the individual's arrival at the unit, the status of nausea (including severity) and vomiting was assessed, and physiological parameters were measured. A cold compress wrapped in gauze was applied to the patient's upper neck area and left in place for five minutes. Following the procedure, the status of nausea (including severity), vomiting, and physiological parameters was re-evaluated. The use of antiemetic and opioid medications was also recorded.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group subjected to ice application | Experimental | Upon the individual's arrival at the unit, the status of nausea (including severity) and vomiting was assessed, and physiological parameters were measured. A cold compress wrapped in gauze was applied to the patient's upper neck area and left in place for five minutes. Following the procedure, the status of nausea (including severity), vomiting, and physiological parameters was re-evaluated. The use of antiemetic and opioid medications was also recorded. Receives: Other: ICE |
| CONTROL | No intervention | When the individual arrived at the unit, their nausea status (including severity) and vomiting status were assessed, and physiological parameters were measured prior to the intervention. No cold application was performed. Following the procedure, nausea status (including severity), vomiting status, and physiological parameters were reassessed. The use of antiemetic and opioid medications was also recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
The VAS is a scale ranging from 0 ("no nausea") to 10 ("very severe nausea"), with numerical values assigned at one-centimeter intervals. The following were rated: nausea severity, peak nausea severity, nausea severity during activity, nausea severity at rest, retching/vomiting severity, and peak retching/vomiting severity.
Measured: 15 months
Secondary outcomes (1)
Apfel Nausea and Vomiting Risk Score
To predict the development of postoperative nausea and vomiting, the Apfel Risk Score assesses four factors: female gender, non-smoking status, a history of postoperative nausea and vomiting or motion sickness, and postoperative opioid use. Each factor is assigned 1 point. The Apfel risk score ranges from 0 to 4 and is classified into low, moderate, and high-risk categories. An Apfel risk score of 0-1 indicates low risk, 2 indicates moderate risk, and 3-4 indicates high risk.
Measured: 15 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 May 2025
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obese Patients With Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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 are transferred to the gastrointestinal surgery ward following their surgery. Postoperative Metpamid (10 mg/2 mL) is routinely administered to prevent postoperative nausea and vomiting (PONV). Upon arrival at the ward, patients' vital signs are checked by a nurse and recorded in the observation chart. Treatments prescribed by the physician are administered and documented. If patients are sufficiently motivated and their pain is controlled, they are mobilized after the 4th or 6th hour and continue walking every two hours during the first day following mobilization.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, özlem doğu, Sakarya University
- Investigators
- Özlem Doğu, PhD, Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825779
- Sponsor's protocol ID
- E-43012747-050.04-463784-238
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon completion of the study, the data may be shared if requested by researchers.
Publications
Scharfenberg DR, Salcido A, Malone P, Clark J, Steele MA. Managing Postoperative Nausea With an Application of Ice Pack to the Posterior Upper Neck. J Perianesth Nurs. 2022 Dec;37(6):774-777. doi: 10.1016/j.jopan.2021.12.010. Epub 2022 May 28.
PubMed 35637077Gecit S, Ozbayir T. Evaluation of Preoperative Risk Assessment and Postoperative Nausea and Vomiting: Importance for Nurses. J Perianesth Nurs. 2020 Dec;35(6):625-629. doi: 10.1016/j.jopan.2020.04.006. Epub 2020 Aug 7.
PubMed 32778493
Study at a glance
From the registry record, last updated by the sponsor on 17 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 After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07825779
- Acronym / sponsor ID
- E-43012747-050.04-463784-238
- Conditions
- Obese Patients With Bariatric Surgery
- Keywords
- obese patients, nausea and vomiting, cold application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 17 Sep 2026 (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.
Obesity is a chronic disease resulting from an excess of body fat mass relative to lean body mass, characterized by a deterioration in the individual's quality of life and health (Kayar and Utku, 2013; Usta and Çavdar, 2013; Tam and Çakır, 2012; Tuncalı et al., 2018). Bariatric surgery is becoming increasingly common worldwide. Nausea and vomiting are among the most frequently observed complications in these patients. This study will be conducted to assess patients for the risk of nausea and vomiting and to examine the effects of a cold application nursing intervention. The lack of sufficient literature measuring nausea and vomiting in patients following bariatric surgery prompted us to undertake this study.
Detailed description
The analysis of the patients' pre- and post-operative scale scores in this study is expected to reveal an improvement in quality of life, consistent with the findings of similar studies. It is anticipated that the patients' quality of life will increase as they achieve their desired weight and body image, gain mobility, and become more independent in their daily lives. Quality of life is defined as the level of satisfaction shaped by an individual's abilities and lifestyle. Obesity frequently impacts quality of life negatively by affecting the individual psychosocially-particularly through dissatisfaction with their physical appearance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients are transferred to the gastrointestinal surgery ward following their surgery. Postoperative Metpamid (10 mg/2 mL) is routinely administered to prevent postoperative nausea and vomiting (PONV). Upon arrival at the ward, patients' vital signs are checked by a nurse and recorded in the observation chart. Treatments prescribed by the physician are administered and documented. If patients are sufficiently motivated and their pain is controlled, they are mobilized after the 4th or 6th hour and continue walking every two hours during the first day following mobilization.
| Arm | Type | Receives |
|---|---|---|
| Experimental group subjected to ice application | Experimental | Other: ICEUpon the individual's arrival at the unit, the status of nausea (including severity) and vomiting was assessed, and physiological parameters were measured. A cold compress wrapped in gauze was applied to the patient's upper neck area and left in place for five minutes. Following the procedure, the status of nausea (including severity), vomiting, and physiological parameters was re-evaluated. The use of antiemetic and opioid medications was also recorded. |
| CONTROL | No intervention | –When the individual arrived at the unit, their nausea status (including severity) and vomiting status were assessed, and physiological parameters were measured prior to the intervention. No cold application was performed. Following the procedure, nausea status (including severity), vomiting status, and physiological parameters were reassessed. The use of antiemetic and opioid medications was also recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals over the age of 18
- Patients accessible prior to surgery
- Those scheduled to receive general anesthesia only
- Conscious individuals
- Individuals without cognitive or psychiatric disorders
Key exclusion criteria (5 listed)
- Individuals under the age of 18
- Those who experienced serious complications during or after surgery
- Individuals with hearing, visual, speech, or cognitive dysfunction
- Those without neurological problems
- Patients who do not consent to the procedure
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 |
|---|---|---|
| ICEAlso: Experimental group subjected to ice applicationUpon the individual's arrival at the unit, the status of nausea (including severity) and vomiting was assessed, and physiological parameters were measured. A cold compress wrapped in gauze was applied to the patient's upper neck area and left in place for five minutes. Following the procedure, the status of nausea (including severity), vomiting, and physiological parameters was re-evaluated. The use of antiemetic and opioid medications was also recorded. | Other | Experimental group subjected to ice application |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 15 months
The VAS is a scale ranging from 0 ("no nausea") to 10 ("very severe nausea"), with numerical values assigned at one-centimeter intervals. The following were rated: nausea severity, peak nausea severity, nausea severity during activity, nausea severity at rest, retching/vomiting severity, and peak retching/vomiting severity.
1 secondary outcome
Apfel Nausea and Vomiting Risk Score
Time frame: 15 MONTHS
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 17 Sep 2026.
- Background: PubMed 35637077Scharfenberg DR, Salcido A, Malone P, Clark J, Steele MA. Managing Postoperative Nausea With an Application of Ice Pack to the Posterior Upper Neck. J Perianesth Nurs. 2022 Dec;37(6):774-777. doi: 10.1016/j.jopan.2021.12.010. Epub 2022 May 28.
- Background: PubMed 32778493Gecit S, Ozbayir T. Evaluation of Preoperative Risk Assessment and Postoperative Nausea and Vomiting: Importance for Nurses. J Perianesth Nurs. 2020 Dec;35(6):625-629. doi: 10.1016/j.jopan.2020.04.006. Epub 2020 Aug 7.
- Individual participant dataSharing planned: No. Upon completion of the study, the data may be shared if requested by researchers.
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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.
Özlem Doğu, PhD principal investigator
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICE in people with Obese Patients With Bariatric Surgery, run by Sakarya 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 5 inclusion and 5 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 17 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?
Visual Analogue Scale (VAS) (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07825779, which also lists 2 linked publications.
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 17 Sep 2026.