NauseaNCT06954935
Periorbital Massage for Nausea and Vomiting After Laparoscopic Surgery
A study testing periorbital massage in people with Nausea and Vomiting, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy is one of the commonly used surgical treatment methods for gallbladder diseases. However, many patients experience significant nausea and vomiting after laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nausea, Vomiting, Laparoscopic Cholecystectomy
- What is being tested?
- periorbital massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Apr 2025to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who have laparoscopic cholecystectomy surgery under general anesthesia,
- Those between the ages of 18-70,
- Those who do not have a psychiatric disease,
- Those who understand what they read and volunteer patients,
- Those who do not have a hearing or speech problem,
Who cannot join
- Patients undergoing emergency surgery,
- Patients with psychiatric disorders
- Patients who have taken another antiemetic drug within 24 hours before surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tuğba Albayram
Gaziantep
About this study
Official title: Effectiveness of Periorbital Massage in the Management of Nausea and Vomiting After Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy is one of the commonly used surgical treatment methods for gallbladder diseases. However, many patients experience significant nausea and vomiting after laparoscopic cholecystectomy. It is observed that approximately 20% to 30% of patients experience postoperative nausea and vomiting as the most common complaint after laparoscopic cholecystectomy. This study aims to investigate the effectiveness of periorbital massage in postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.
Read the detailed description
This study aimed to investigate the effectiveness of periorbital massage in postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. One group received periorbital massage, while the other group did not receive massage.
- Conditions
- Nausea, Vomiting, Laparoscopic Cholecystectomy
- Being tested
- periorbital massage
- Keywords
- nausea, voming, periorbital massage
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periorbital massageOther
An electronic eye massager (irest manufacturing company, China) will be applied. The massager has a vibration function and massages with a warm air bag.
| Study group | Role | What they receive |
|---|---|---|
| periorbital massage | Experimental | The severity of nausea and frequency of vomiting of patients will be analyzed at the 2nd, 4th, 6th, 8th, 12th and 24th hours after surgery. 15 minutes before these evaluations, an electronic eye massager (irest manufacturing company, China) will be applied to the patient's eyeball (according to the manufacturer's instructions) for 15 minutes. 15 minutes after the intervention, the severity of nausea and vomiting of patients will be evaluated using the nausea numerical scale and the vomiting incidence evaluation form. Receives: Other: periorbital massage |
| control | No intervention | The severity of nausea and frequency of vomiting of patients will be analyzed at 2, 4, 6, 8, 12 and 24 hours after surgery. Data collection intervals will be the same in both control and intervention groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apfel risk score
: Apfel Risk Score is a simple scoring used to determine the risk status of patients for PONV. Apfel Risk Score questions four factors such as being female, not smoking, having a history of PONV/motion sickness and using postoperative opioids. Each factor is evaluated as 1 point. Apfel risk score varies between 0-4 and is classified as low, medium and high risk. Apfel Risk score 0-1 is evaluated as low risk, 2 as medium risk and 3-4 as high risk.
Measured: It will be filled half an hour before you go down for surgery.
Numerical Scale of Nausea
The numerical scale of nausea is a scale that starts with "0 (no nausea)" and ends with "10 (very severe nausea)" and is given a numerical value with 1 cm intervals. The numerical scale is one-dimensional and is mainly used to evaluate the severity of pain.
Measured: 0, 2, 6, 12 and 24 hours after surgery
Postoperative Nausea and Vomiting Impact Scale
There are four options in the two-question scale, each with 0, 1, 2, or 3 points. The first question asks whether there is vomiting or retching, if any, and the frequency; the answers are "0" no, "1" once, "2" twice, "3" three times or more, with four options. The second question asks whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), if any, whether the feeling of nausea affects your ability to get out of bed, move around comfortably in bed, walk normally, or your daily life activities such as eating and drinking; the answers are "0" not very often, "1" sometimes, "2" often or often, and "3" always, with four options. The numerical values of the answers given to the first and second questions are added up and the result is found.
Measured: 0, 2, 6, 12 and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start23 Apr 2025
- Primary completion25 Aug 2025 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies 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
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagla Toprak, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954935
- Sponsor's protocol ID
- 23.12.2024 10/3
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 2 May 2025
- 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 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Periorbital Massage in the Management of Nausea and Vomiting After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06954935
- Acronym / sponsor ID
- 23.12.2024 10/3
- Conditions
- Nausea, Vomiting, Laparoscopic Cholecystectomy
- Keywords
- nausea, voming, periorbital massage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 2 May 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.
Laparoscopic cholecystectomy is one of the commonly used surgical treatment methods for gallbladder diseases. However, many patients experience significant nausea and vomiting after laparoscopic cholecystectomy. It is observed that approximately 20% to 30% of patients experience postoperative nausea and vomiting as the most common complaint after laparoscopic cholecystectomy. This study aims to investigate the effectiveness of periorbital massage in postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.
Detailed description
This study aimed to investigate the effectiveness of periorbital massage in postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. One group received periorbital massage, while the other group did not receive massage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| periorbital massage | Experimental | Other: periorbital massageThe severity of nausea and frequency of vomiting of patients will be analyzed at the 2nd, 4th, 6th, 8th, 12th and 24th hours after surgery. 15 minutes before these evaluations, an electronic eye massager (irest manufacturing company, China) will be applied to the patient's eyeball (according to the manufacturer's instructions) for 15 minutes. 15 minutes after the intervention, the severity of nausea and vomiting of patients will be evaluated using the nausea numerical scale and the vomiting incidence evaluation form. |
| control | No intervention | –The severity of nausea and frequency of vomiting of patients will be analyzed at 2, 4, 6, 8, 12 and 24 hours after surgery. Data collection intervals will be the same in both control and intervention groups. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Those who have laparoscopic cholecystectomy surgery under general anesthesia,
- Those between the ages of 18-70,
- Those who do not have a psychiatric disease,
- Those who understand what they read and volunteer patients,
- Those who do not have a hearing or speech problem,
Key exclusion criteria (3 listed)
- Patients undergoing emergency surgery,
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 |
|---|---|---|
| periorbital massageAn electronic eye massager (irest manufacturing company, China) will be applied. The massager has a vibration function and massages with a warm air bag. | Other | periorbital massage |
Primary outcome
Apfel risk score
Time frame: It will be filled half an hour before you go down for surgery.
: Apfel Risk Score is a simple scoring used to determine the risk status of patients for PONV. Apfel Risk Score questions four factors such as being female, not smoking, having a history of PONV/motion sickness and using postoperative opioids. Each factor is evaluated as 1 point. Apfel risk score varies between 0-4 and is classified as low, medium and high risk. Apfel Risk score 0-1 is evaluated as low risk, 2 as medium risk and 3-4 as high risk.
Numerical Scale of Nausea
Time frame: 0, 2, 6, 12 and 24 hours after surgery
The numerical scale of nausea is a scale that starts with "0 (no nausea)" and ends with "10 (very severe nausea)" and is given a numerical value with 1 cm intervals. The numerical scale is one-dimensional and is mainly used to evaluate the severity of pain.
Postoperative Nausea and Vomiting Impact Scale
Time frame: 0, 2, 6, 12 and 24 hours after surgery
There are four options in the two-question scale, each with 0, 1, 2, or 3 points. The first question asks whether there is vomiting or retching, if any, and the frequency; the answers are "0" no, "1" once, "2" twice, "3" three times or more, with four options. The second question asks whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), if any, whether the feeling of nausea affects your ability to get out of bed, move around comfortably in bed, walk normally, or your daily life activities such as eating and drinking; the answers are "0" not very often, "1" sometimes, "2" often or often, and "3" always, with four options. The numerical values of the answers given to the first and second questions are added up and the result is found.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing periorbital massage in people with Nausea and Vomiting, run by Atlas 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 3 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: looking for participants now, as of the sponsor's last update on 2 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact çağla toprak (532 799 78 14, cagla.toprak@atlas.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apfel risk score (time frame: It will be filled half an hour before you go down for surgery.). 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 2 May 2025.