Vomiting, PostoperativeNCT07712211
Association Between Pain Catastrophizing and PONV in Laparoscopic Cholecystectomy Patients
An observational study of Vomiting, Postoperative and Pain, run by Trabzon Kanuni Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to explore whether patients' tendency to exaggerate or focus on pain (pain catastrophizing) is related to experiencing nausea and vomiting after surgery. The study will include patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vomiting, Postoperative, Pain, Nausea and Vomiting, Postoperative
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to Apr 2027
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of patients undergoing elective laparoscopic cholecystectomy at Trabzon University Faculty of Medicine, Kanuni Training and Research Hospital
Who may be able to join
- Adult patients aged 18-65 years
- American Society of Anesthesiologists (ASA) physical status I-II-III
- Scheduled for elective laparoscopic cholecystectomy
- Able to provide informed consent
Who cannot join
- Age <18 or >65 years
- Emergency surgery
- ASA physical status > III
- Pregnancy
- Chronic opioid use
- Known drug allergy
Show all 12Show fewer
- Psychiatric disorders
- Neurological diseases (central or peripheral neuropathy)
- History of cerebrovascular disease (stroke)
- Chronic renal disease
- Chronic pulmonary disease
- Patients who refuse to participate
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
Trabzon Kanuni Education and Research Hospital
Trabzon
recep erin, doctor, +905304699135, erinrecep@gmail.com
Sedanur sula
About this study
Official title: The Relationship Between Pain Catastrophizing Scale and Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy
This study aims to explore whether patients' tendency to exaggerate or focus on pain (pain catastrophizing) is related to experiencing nausea and vomiting after surgery. The study will include patients undergoing laparoscopic cholecystectomy. Before surgery, patients will answer questions measuring pain catastrophizing and rate their pain during intravenous cannulation. Nausea and vomiting will be assessed at various times during the first 24 hours after surgery. The results may help better understand how psychological factors affect postoperative symptoms.
Read the detailed description
This study is designed as a prospective, cross-sectional, and observational study. The Pain Catastrophizing Scale (PCS) is a well-established self-report instrument developed to assess catastrophic thinking related to pain. It evaluates how individuals perceive and respond to pain, focusing on tendencies such as rumination, magnification, and feelings of helplessness. Evidence suggests that PCS is a strong predictor of pain intensity, independent of anxiety levels. In this study, the validated Turkish version of the Pain Catastrophizing Scale will be used.
Postoperative nausea, vomiting, and retching are common adverse events that can complicate recovery from anesthesia. Patients often perceive these symptoms as more distressing than postoperative pain, and they represent important outcomes affecting patient satisfaction and recovery.
The present study aims to investigate the relationship between pain perception during intravenous (IV) cannulation, pain catastrophizing levels, and postoperative nausea and vomiting. By evaluating numeric pain scores during IV access alongside PCS scores, this study seeks to explore whether preoperative pain perception and psychological factors are associated with the frequency of postoperative nausea and vomiting.
The findings of this study are expected to contribute to a better understanding of the role of psychological factors in postoperative symptoms and may help improve anesthesia practices by supporting more individualized, patient-centered perioperative care.
- Keywords
- The Pain Catastrophizing Scale, Postoperative Nausea and Vomiting, Laparoscopic Cholecystectomy
- Medical subject headings
- Postoperative Nausea and Vomiting, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients undergoing elective laparoscopic cholecystectomy | Aged 18 to 65 years, American Society of Anesthesiologists (ASA) physical status of I, II, III; Patients scheduled for emergency surgery , those with significant systemic diseases (ASA > III), pregnancy, chronic opioid use, psychiatric disorders, neurological diseases, chronic renal or pulmonary disease, or those who do not provide informed consent will be exclude |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and vomiting (PONV)
The primary outcome is the incidence of postoperative nausea and vomiting (PONV) according to preoperative Pain Catastrophizing Scale (PCS) scores. Patients will be evaluated for PONV at 0, 3, 6, 12, and 24 hours postoperatively. The relationship between PCS scores and the frequency of PONV will be analyzed.
Measured: Within 24 hours postoperatively
Secondary outcomes (1)
Association between IV cannulation pain and pain catastrophizing
The secondary outcome is the relationship between pain experienced during intravenous (IV) cannulation and preoperative Pain Catastrophizing Scale (PCS) scores. Pain during IV access will be measured using a numeric rating scale (0-10). The association between IV pain scores and PCS scores will be analyzed
Measured: Preoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start15 Jan 2026
- Primary completion15 Jul 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trabzon Kanuni Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712211
- Sponsor's protocol ID
- 10496660-2026/25027
- Status last verified
- Jan 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022.
PubMed 10475299Uğurlu M, Karakaş Uğurlu G, Erten Ş, Çayköylü A. Validity of Turkish form of Pain Catastrophizing Scale and modeling of the relationship between pain-related disability with pain intensity, cognitive, and emotional factors. Psychiatry and Clinical Psychopharmacology. 2017;27(2):189-196. doi:10.1080/24750573.2017.1322672
Borna S, Ho OA, Gomez-Cabello CA, Haider SA, Genovese A, Prabha S, Haider CR, Felton CL, McLeod CJ, Bruce CJ, Carter RE, Forte AJ. Impact of Demographics and Psychological Factors on Three-Day Postoperative Pain Perception Following Hand Surgery. J Clin Med. 2024 Dec 25;14(1):37. doi: 10.3390/jcm14010037.
PubMed 39797119
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Pain Catastrophizing Scale and Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07712211
- Acronym / sponsor ID
- 10496660-2026/25027
- Keywords
- The Pain Catastrophizing Scale, Postoperative Nausea and Vomiting, Laparoscopic Cholecystectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Trabzon Kanuni Education and Research HospitalUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 17 Jul 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.
This study aims to explore whether patients' tendency to exaggerate or focus on pain (pain catastrophizing) is related to experiencing nausea and vomiting after surgery. The study will include patients undergoing laparoscopic cholecystectomy. Before surgery, patients will answer questions measuring pain catastrophizing and rate their pain during intravenous cannulation. Nausea and vomiting will be assessed at various times during the first 24 hours after surgery. The results may help better understand how psychological factors affect postoperative symptoms.
Detailed description
This study is designed as a prospective, cross-sectional, and observational study. The Pain Catastrophizing Scale (PCS) is a well-established self-report instrument developed to assess catastrophic thinking related to pain. It evaluates how individuals perceive and respond to pain, focusing on tendencies such as rumination, magnification, and feelings of helplessness. Evidence suggests that PCS is a strong predictor of pain intensity, independent of anxiety levels. In this study, the validated Turkish version of the Pain Catastrophizing Scale will be used.
Postoperative nausea, vomiting, and retching are common adverse events that can complicate recovery from anesthesia. Patients often perceive these symptoms as more distressing than postoperative pain, and they represent important outcomes affecting patient satisfaction and recovery.
The present study aims to investigate the relationship between pain perception during intravenous (IV) cannulation, pain catastrophizing levels, and postoperative nausea and vomiting. By evaluating numeric pain scores during IV access alongside PCS scores, this study seeks to explore whether preoperative pain perception and psychological factors are associated with the frequency of postoperative nausea and vomiting.
The findings of this study are expected to contribute to a better understanding of the role of psychological factors in postoperative symptoms and may help improve anesthesia practices by supporting more individualized, patient-centered perioperative care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients undergoing elective laparoscopic cholecystectomy | – | –Aged 18 to 65 years, American Society of Anesthesiologists (ASA) physical status of I, II, III; Patients scheduled for emergency surgery , those with significant systemic diseases (ASA > III), pregnancy, chronic opioid use, psychiatric disorders, neurological diseases, chronic renal or pulmonary disease, or those who do not provide informed consent will be exclude |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients undergoing elective laparoscopic cholecystectomy at Trabzon University Faculty of Medicine, Kanuni Training and Research Hospital
Key inclusion criteria (4 listed)
- Adult patients aged 18-65 years
- American Society of Anesthesiologists (ASA) physical status I-II-III
- Scheduled for elective laparoscopic cholecystectomy
- Able to provide informed consent
Key exclusion criteria (12 listed)
- Age <18 or >65 years
- Emergency surgery
- ASA physical status > III
- Pregnancy
- Chronic opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative nausea and vomiting (PONV)
Time frame: Within 24 hours postoperatively
The primary outcome is the incidence of postoperative nausea and vomiting (PONV) according to preoperative Pain Catastrophizing Scale (PCS) scores. Patients will be evaluated for PONV at 0, 3, 6, 12, and 24 hours postoperatively. The relationship between PCS scores and the frequency of PONV will be analyzed.
1 secondary outcome
Association between IV cannulation pain and pain catastrophizing
Time frame: Preoperative period
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 17 Jul 2026.
- Background: PubMed 10475299Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022.
- BackgroundUğurlu M, Karakaş Uğurlu G, Erten Ş, Çayköylü A. Validity of Turkish form of Pain Catastrophizing Scale and modeling of the relationship between pain-related disability with pain intensity, cognitive, and emotional factors. Psychiatry and Clinical Psychopharmacology. 2017;27(2):189-196. doi:10.1080/24750573.2017.1322672
- Background: PubMed 39797119Borna S, Ho OA, Gomez-Cabello CA, Haider SA, Genovese A, Prabha S, Haider CR, Felton CL, McLeod CJ, Bruce CJ, Carter RE, Forte AJ. Impact of Demographics and Psychological Factors on Three-Day Postoperative Pain Perception Following Hand Surgery. J Clin Med. 2024 Dec 25;14(1):37. doi: 10.3390/jcm14010037.
- Individual participant dataSharing planned: No
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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?
An observational study of Vomiting, Postoperative and Pain, run by Trabzon Kanuni Education and Research Hospital 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 4 inclusion and 12 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 17 Jul 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?
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 sedanur sula (+905424096196, sulasedanur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative nausea and vomiting (PONV) (time frame: Within 24 hours postoperatively). 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 NCT07712211, which also lists 3 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 Jul 2026.