NCT07712211

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Jan 2026Apr 2027

Study Start

First participant enrolled

January 15, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2026

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

July 17, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

July 14, 2026

Last Update Submit

July 14, 2026

Conditions

Keywords

The Pain Catastrophizing ScalePostoperative Nausea and VomitingLaparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 24 hours postoperatively

Secondary Outcomes (1)

  • Association between IV cannulation pain and pain catastrophizing

    Preoperative period

Study Arms (1)

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients undergoing elective laparoscopic cholecystectomy at Trabzon University Faculty of Medicine, Kanuni Training and Research Hospital

You may qualify if:

  • 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

You may not qualify if:

  • Age \<18 or \>65 years
  • Emergency surgery
  • ASA physical status \> III
  • Pregnancy
  • Chronic opioid use
  • Known drug allergy
  • Psychiatric disorders
  • Neurological diseases (central or peripheral neuropathy)
  • History of cerebrovascular disease (stroke)
  • Chronic renal disease
  • Chronic pulmonary disease
  • Patients who refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trabzon Kanuni Education and Research Hospital

Trabzon, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

    PMID: 10475299BACKGROUND
  • Uğurlu 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
  • 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.

    PMID: 39797119BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and VomitingPain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomitingNeurologic Manifestations

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 17, 2026

Study Start

January 15, 2026

Primary Completion

July 15, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

July 17, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations