Preoperative AnxietyNCT07451925
Prediction of Postoperative Pain Using Venous Cannulation Pain and Preoperative Anxiety Scores
An observational study of Preoperative Anxiety and Postoperative Pain, run by Fatih Sultan Mehmet Training and Research Hospital.
Trial summary
Postoperative pain remains a significant clinical problem affecting recovery, mobilization, and patient satisfaction after surgery. Considerable interindividual variability exists in postoperative pain intensity even among patients undergoing the same surgical procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Anxiety, Postoperative Pain
- What is being tested?
- APAIS Assessment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2026to 1 Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adult patients undergoing elective laparoscopic cholecystectomy under standardized general anesthesia
Who may be able to join
- Age ≥18 years
- ASA physical status I-III
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- Ability to understand and use the Visual Analog Scale (VAS)
- Ability to complete the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
- Provision of written informed consent
Who cannot join
- Emergency surgery
- Conversion from laparoscopic to open surgery
- Cognitive impairment or inability to communicate effectively
- Chronic pain lasting longer than 3 months
- More than three venous cannulation attempts
- Surgical duration exceeding 2 hours
- Refusal to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Association of Venous Cannulation Pain and Preoperative Anxiety (APAIS) With Postoperative Pain Following Elective Laparoscopic Cholecystectomy: A Prospective Observational Study
Postoperative pain remains a significant clinical problem affecting recovery, mobilization, and patient satisfaction after surgery. Considerable interindividual variability exists in postoperative pain intensity even among patients undergoing the same surgical procedure. This variability may be influenced not only by the extent of surgical trauma but also by individual pain sensitivity and psychological factors such as preoperative anxiety.
The aim of this prospective observational study is to evaluate whether pain intensity reported during routine venous cannulation and preoperative anxiety levels assessed by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) can predict early postoperative pain severity in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Venous cannulation pain will be assessed using a 0-10 visual analog scale (VAS), and anxiety levels will be measured preoperatively using APAIS. Postoperative pain will be evaluated at predefined time points within the first 12 hours after surgery using VAS scores and analgesic consumption. Identifying simple and easily obtainable preoperative predictors may allow individualized postoperative analgesic strategies for patients at higher risk of severe postoperative pain.
Read the detailed description
Postoperative pain is a common and clinically relevant problem that negatively affects recovery, early mobilization, patient satisfaction, and overall surgical outcomes. Despite standardized anesthetic and analgesic protocols, significant interindividual variability exists in postoperative pain intensity among patients undergoing the same surgical procedure. This variability may be influenced not only by surgical factors but also by individual pain sensitivity and psychological characteristics, particularly preoperative anxiety.
Pain experienced during routine preoperative procedures such as venous cannulation may reflect individual pain sensitivity and central pain processing mechanisms. Similarly, elevated preoperative anxiety levels have been associated with increased postoperative pain intensity and higher analgesic requirements. The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a validated instrument widely used to quantify preoperative anxiety.
This prospective observational study aims to investigate the predictive value of pain reported during venous cannulation and preoperative anxiety levels assessed by APAIS on early postoperative pain severity in patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
After obtaining ethics committee approval and written informed consent, adult patients (≥18 years) classified as ASA I-III and scheduled for elective laparoscopic cholecystectomy under general anesthesia will be enrolled. Patients undergoing emergency surgery, conversion to open surgery, those with cognitive impairment, chronic pain lasting more than three months, multiple venous cannulation attempts (≥3), or surgical duration exceeding two hours will be excluded.
Preoperative anxiety will be assessed using APAIS prior to transfer to the operating room. Venous cannulation will be performed routinely with a 20G intravenous catheter on the dorsum of the hand by an experienced practitioner. Pain intensity during cannulation will be assessed using a 0-10 visual analog scale (VAS).
All patients will receive standardized general anesthesia and postoperative analgesia according to institutional protocols. Postoperative pain intensity will be evaluated using VAS at predefined time points: upon arrival in the post-anesthesia care unit, at 30 minutes, 2 hours, 6 hours, and 12 hours postoperatively. Rescue analgesia and total analgesic consumption during the first 12 hours will be recorded.
Statistical analysis will evaluate correlations between venous cannulation pain, APAIS scores, and postoperative VAS scores. Multivariable regression analysis will be performed to identify independent predictors of postoperative pain intensity.
By identifying simple and easily obtainable preoperative indicators of postoperative pain risk, this study aims to contribute to individualized analgesic strategies and improved perioperative pain management.
- Conditions
- Preoperative Anxiety, Postoperative Pain
- Being tested
- APAIS Assessment
- Keywords
- APAIS, postoperative pain, preoperative anxiety, Laparoscopic Cholecystectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APAIS AssessmentOther
Also called Venous Cannulation Pain Assessment
Preoperative anxiety is evaluated using the Amsterdam Preoperative Anxiety and Information Scale (APAIS).Pain during routine venous cannulation is assessed using a 0-10 visual analog scale (VAS).
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Elective Laparoscopic Cholecystectomy | Adult patients (≥18 years) classified as ASA physical status I-III and scheduled for elective laparoscopic cholecystectomy under general anesthesia will be enrolled. Patients undergoing emergency surgery, conversion to open surgery, those with cognitive impairment, chronic pain lasting more than three months, multiple venous cannulation attempts (≥3), or surgical duration exceeding two hours will be excluded. All participants will undergo standardized anesthesia and postoperative analgesia according to institutional protocols. Receives: Other: APAIS Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Postoperative Pain Intensity
Postoperative pain intensity assessed using a 0-10 visual analog scale (VAS).
Measured: Within the first 12 hours after surgery (upon arrival in the post-anesthesia care unit, at 30 minutes, 2 hours, 6 hours, and 12 hours postoperatively)
Secondary outcomes (1)
Total Analgesic Consumption
Total amount of analgesic medications administered during the first 12 postoperative hours, including rescue analgesics.
Measured: First 12 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 posted5 Mar 2026
- Study start2 Mar 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arsen Gungor Ay, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451925
- Sponsor's protocol ID
- IVLINEVAS
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The final decision regarding individual participant data (IPD) sharing has not yet been determined. Data sharing policies will be established following completion of the study and publication of the primary results, in accordance with institutional regulations and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Venous Cannulation Pain and Preoperative Anxiety (APAIS) With Postoperative Pain Following Elective Laparoscopic Cholecystectomy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07451925
- Acronym / sponsor ID
- IVLINEVAS
- Conditions
- Preoperative Anxiety, Postoperative Pain
- Keywords
- APAIS, postoperative pain, preoperative anxiety, Laparoscopic Cholecystectomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 5 Mar 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.
Postoperative pain remains a significant clinical problem affecting recovery, mobilization, and patient satisfaction after surgery. Considerable interindividual variability exists in postoperative pain intensity even among patients undergoing the same surgical procedure. This variability may be influenced not only by the extent of surgical trauma but also by individual pain sensitivity and psychological factors such as preoperative anxiety.
The aim of this prospective observational study is to evaluate whether pain intensity reported during routine venous cannulation and preoperative anxiety levels assessed by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) can predict early postoperative pain severity in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Venous cannulation pain will be assessed using a 0-10 visual analog scale (VAS), and anxiety levels will be measured preoperatively using APAIS. Postoperative pain will be evaluated at predefined time points within the first 12 hours after surgery using VAS scores and analgesic consumption. Identifying simple and easily obtainable preoperative predictors may allow individualized postoperative analgesic strategies for patients at higher risk of severe postoperative pain.
Detailed description
Postoperative pain is a common and clinically relevant problem that negatively affects recovery, early mobilization, patient satisfaction, and overall surgical outcomes. Despite standardized anesthetic and analgesic protocols, significant interindividual variability exists in postoperative pain intensity among patients undergoing the same surgical procedure. This variability may be influenced not only by surgical factors but also by individual pain sensitivity and psychological characteristics, particularly preoperative anxiety.
Pain experienced during routine preoperative procedures such as venous cannulation may reflect individual pain sensitivity and central pain processing mechanisms. Similarly, elevated preoperative anxiety levels have been associated with increased postoperative pain intensity and higher analgesic requirements. The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a validated instrument widely used to quantify preoperative anxiety.
This prospective observational study aims to investigate the predictive value of pain reported during venous cannulation and preoperative anxiety levels assessed by APAIS on early postoperative pain severity in patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
After obtaining ethics committee approval and written informed consent, adult patients (≥18 years) classified as ASA I-III and scheduled for elective laparoscopic cholecystectomy under general anesthesia will be enrolled. Patients undergoing emergency surgery, conversion to open surgery, those with cognitive impairment, chronic pain lasting more than three months, multiple venous cannulation attempts (≥3), or surgical duration exceeding two hours will be excluded.
Preoperative anxiety will be assessed using APAIS prior to transfer to the operating room. Venous cannulation will be performed routinely with a 20G intravenous catheter on the dorsum of the hand by an experienced practitioner. Pain intensity during cannulation will be assessed using a 0-10 visual analog scale (VAS).
All patients will receive standardized general anesthesia and postoperative analgesia according to institutional protocols. Postoperative pain intensity will be evaluated using VAS at predefined time points: upon arrival in the post-anesthesia care unit, at 30 minutes, 2 hours, 6 hours, and 12 hours postoperatively. Rescue analgesia and total analgesic consumption during the first 12 hours will be recorded.
Statistical analysis will evaluate correlations between venous cannulation pain, APAIS scores, and postoperative VAS scores. Multivariable regression analysis will be performed to identify independent predictors of postoperative pain intensity.
By identifying simple and easily obtainable preoperative indicators of postoperative pain risk, this study aims to contribute to individualized analgesic strategies and improved perioperative pain management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Elective Laparoscopic Cholecystectomy | – | Other: APAIS AssessmentAdult patients (≥18 years) classified as ASA physical status I-III and scheduled for elective laparoscopic cholecystectomy under general anesthesia will be enrolled. Patients undergoing emergency surgery, conversion to open surgery, those with cognitive impairment, chronic pain lasting more than three months, multiple venous cannulation attempts (≥3), or surgical duration exceeding two hours will be excluded. All participants will undergo standardized anesthesia and postoperative analgesia according to institutional protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients undergoing elective laparoscopic cholecystectomy under standardized general anesthesia
Key inclusion criteria (6 listed)
- Age ≥18 years
- ASA physical status I-III
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- Ability to understand and use the Visual Analog Scale (VAS)
- Ability to complete the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Key exclusion criteria (7 listed)
- Emergency surgery
- Conversion from laparoscopic to open surgery
- Cognitive impairment or inability to communicate effectively
- Chronic pain lasting longer than 3 months
- More than three venous cannulation attempts
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 |
|---|---|---|
| APAIS AssessmentAlso: Venous Cannulation Pain AssessmentPreoperative anxiety is evaluated using the Amsterdam Preoperative Anxiety and Information Scale (APAIS).Pain during routine venous cannulation is assessed using a 0-10 visual analog scale (VAS). | Other | Patients Undergoing Elective Laparoscopic Cholecystectomy |
Primary outcome
Early Postoperative Pain Intensity
Time frame: Within the first 12 hours after surgery (upon arrival in the post-anesthesia care unit, at 30 minutes, 2 hours, 6 hours, and 12 hours postoperatively)
Postoperative pain intensity assessed using a 0-10 visual analog scale (VAS).
1 secondary outcome
Total Analgesic Consumption
Time frame: First 12 hours after surgery
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 5 Mar 2026.
- Individual participant dataSharing planned: Undecided. The final decision regarding individual participant data (IPD) sharing has not yet been determined. Data sharing policies will be established following completion of the study and publication of the primary results, in accordance with institutional regulations and ethical considerations.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Preoperative Anxiety and Postoperative Pain, run by Fatih Sultan Mehmet Training and Research Hospital.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Arsen Gungor Ay, specialist (+905534948426, arsen.gungor@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Postoperative Pain Intensity (time frame: Within the first 12 hours after surgery (upon arrival in the post-anesthesia care unit, at 30 minutes, 2 hours, 6 hours, and 12 hours postoperatively)). 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 5 Mar 2026.