Catastrophizing PainNCT06838897
Preoperative Pain Catastrophizing and Intraoperative Analgesia Consumption
An observational study of Catastrophizing Pain and Pain, run by Ahmet Pece at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to evaluate the relationship between the Pain Catastrophizing Scale (PCS) and intraoperative analgesia consumption in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Catastrophizing Pain, Pain
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Apr 2025to 7 Jul 2025
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective laparoscopic cholecystectomy.
Who may be able to join
- Patients with ASA scores of I-III
- Patients with Turkish literacy skills.
- Patients scheduled for elective laparoscopic cholecystectomy.
Who cannot join
- Patients unwillingness to participate in the study.
- Conversion of surgery from laparoscopic to open surgery.
- Patients undergoing emergency laparoscopic cholecystectomy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Üniversitesi Eğitim Ve Araştırma Hastanesi
Samsun, ilkadım, 55100
About this study
Official title: Association Between Preoperative Pain Catastrophizing Scale and Intraoperative Analgesia Consumption in Elective Laparoscopic Cholecystectomy
This observational study aims to evaluate the relationship between the Pain Catastrophizing Scale (PCS) and intraoperative analgesia consumption in patients undergoing laparoscopic cholecystectomy. During the preoperative period, patients will complete the Pain Catastrophizing Scale, the Beck Depression Inventory, and the Beck Anxiety Scale. During the intraoperative period, analgesia nociceptive index (ANI) electrodes will be placed, and remifentanil dosing will be adjusted accordingly. The correlation between preoperative Pain Catastrophizing Scale scores and intraoperative remifentanil consumption will be analyzed.
- Conditions
- Catastrophizing Pain, Pain
- Keywords
- pain
- Medical subject headings
- 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 |
|---|---|---|
| Patients undergoing laparoscopic cholecystectomy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative remifentanyl requirement
The main purpose of this study is to evaluate the correlation between preoperative Pain Catastrophizing Scale and intraoperative analgesia consumption.Intraoperative analgesic dose is adjusted according to the analgesia nociceptive index.
Measured: Intraoperative period
Secondary outcomes (1)
Numeric rating scale for postoperative pain intensity
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale in which a respondent selectsand its correlation with the preoperative PCS score will be investigated.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start11 Apr 2025
- Primary completion30 Jun 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catastrophizing PainStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmet Pece
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmet Pece, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838897
- Sponsor's protocol ID
- ceyla kolesistektomi
- Status last verified
- Jul 2025
- First submitted
- 16 Feb 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Preoperative Pain Catastrophizing Scale and Intraoperative Analgesia Consumption in Elective Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06838897
- Acronym / sponsor ID
- ceyla kolesistektomi
- Conditions
- Catastrophizing Pain, Pain
- Keywords
- pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ahmet PeceUniversity, hospital or other
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 21 Feb 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.
This observational study aims to evaluate the relationship between the Pain Catastrophizing Scale (PCS) and intraoperative analgesia consumption in patients undergoing laparoscopic cholecystectomy. During the preoperative period, patients will complete the Pain Catastrophizing Scale, the Beck Depression Inventory, and the Beck Anxiety Scale. During the intraoperative period, analgesia nociceptive index (ANI) electrodes will be placed, and remifentanil dosing will be adjusted accordingly. The correlation between preoperative Pain Catastrophizing Scale scores and intraoperative remifentanil consumption will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing laparoscopic cholecystectomy | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective laparoscopic cholecystectomy.
Key inclusion criteria (3 listed)
- Patients with ASA scores of I-III
- Patients with Turkish literacy skills.
- Patients scheduled for elective laparoscopic cholecystectomy.
Key exclusion criteria (3 listed)
- Patients unwillingness to participate in the study.
- Conversion of surgery from laparoscopic to open surgery.
- Patients undergoing emergency laparoscopic cholecystectomy.
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
Intraoperative remifentanyl requirement
Time frame: Intraoperative period
The main purpose of this study is to evaluate the correlation between preoperative Pain Catastrophizing Scale and intraoperative analgesia consumption.Intraoperative analgesic dose is adjusted according to the analgesia nociceptive index.
1 secondary outcome
Numeric rating scale for postoperative pain intensity
Time frame: up to 24 hours
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 23 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Catastrophizing Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Not yet recruiting
Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy
Chronic Low Back Pain (CLBP)
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Catastrophizing Pain and Pain, run by Ahmet Pece 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 3 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: finished, as of the sponsor's last update on 23 Jul 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?
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?
Intraoperative remifentanyl requirement (time frame: Intraoperative period). 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 23 Jul 2025.