Cholecystectomy, LaparoscopicNCT07457905
THE RELATIONSHIP BETWEEN PAIN ANXIETY AND POST-OPERATIVE PAIN IN PATIENTS UNDERGOING CHOLECYSTECTOMY SURGERY
An observational study of Cholecystectomy, Laparoscopic, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
This descriptive observational study aims to examine the relationship between preoperative fear of postoperative pain and postoperative pain intensity in patients undergoing cholecystectomy. Postoperative pain is one of the most common and significant clinical problems following surgical procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystectomy, Laparoscopic
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2026to 30 Dec 2026
- How long will I take part?
- 106 Years
- 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 comprises adult patients undergoing elective cholecystectomy in the general surgery clinics of a tertiary care hospital. Consecutive eligible patients who meet the predefined inclusion criteria will be prospectively enrolled during the study period. The population represents surgical patients diagnosed primarily with cholelithiasis or cholecystitis.
Who may be able to join
- Adults aged 18 years and older Scheduled for elective cholecystectomy Able to speak and understand Turkish Conscious and able to complete questionnaires independently Voluntarily agree to participate in the study
Who cannot join
- Use of anxiolytic medication Diagnosed psychiatric disorder that may affect pain perception Cognitive impairment preventing completion of study forms Emergency cholecystectomy Development of major postoperative complications requiring intensive care
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
Haydarpaşa Numune Trainingand Research Hospital
Istanbul
SEDA AKKAYA, MSc, 5057678339, sedakkaya@stu.okan.edu.tr
About this study
This descriptive observational study aims to examine the relationship between preoperative fear of postoperative pain and postoperative pain intensity in patients undergoing cholecystectomy.
Postoperative pain is one of the most common and significant clinical problems following surgical procedures. Psychological factors such as anxiety and fear of pain are known to influence pain perception and recovery outcomes. Preoperative fear related to postoperative pain may increase perceived pain intensity and negatively affect the postoperative recovery process.
Read more
The study will be conducted in the general surgery clinics of a tertiary care hospital. A total of 106 adult patients scheduled for cholecystectomy will be included. Preoperative fear of postoperative pain will be assessed one day before surgery using the Postoperative Pain Fear Scale. Postoperative pain intensity will be evaluated using the Numeric Rating Scale at the 4th, 12th, and 24th hours after surgery.
The findings of this study are expected to contribute to a better understanding of the relationship between preoperative pain-related fear and postoperative pain severity, and to provide evidence to improve perioperative nursing care and pain management strategies.
Read the detailed description
Cholecystectomy is one of the most frequently performed surgical procedures worldwide for the management of cholelithiasis and acute or chronic cholecystitis. Although laparoscopic techniques have significantly reduced surgical trauma and enhanced recovery, postoperative pain remains a prevalent and clinically relevant problem. Inadequate pain control may impair early mobilization, respiratory function, wound healing, and overall recovery, potentially increasing morbidity and healthcare costs.
Postoperative pain is a multidimensional phenomenon influenced by both physiological and psychological factors. Among psychological determinants, preoperative fear of postoperative pain has been identified as a potential predictor of increased pain perception and adverse recovery outcomes. Fear-related cognitive processes may amplify central pain processing mechanisms, heighten pain sensitivity, and contribute to increased analgesic requirements. Despite growing evidence regarding the impact of psychological variables on surgical outcomes, the relationship between preoperative fear of postoperative pain and early postoperative pain intensity in patients undergoing cholecystectomy has not been sufficiently clarified.
This prospective descriptive observational study aims to investigate the association between preoperative fear of postoperative pain and postoperative pain intensity in adult patients undergoing elective cholecystectomy. The study will be conducted in the general surgery clinics of a tertiary care hospital. A total of 106 patients meeting the eligibility criteria will be consecutively recruited.
Preoperative fear of postoperative pain will be assessed one day prior to surgery using the Postoperative Pain Fear Scale. Postoperative pain intensity will be measured using the Numeric Rating Scale at the 4th, 12th, and 24th postoperative hours. Sociodemographic and clinical variables will also be collected to control for potential confounding factors.
Descriptive statistics will be used to summarize patient characteristics. The relationship between preoperative fear scores and postoperative pain intensity will be analyzed using correlation and regression analyses. A p-value of <0.05 will be considered statistically significant.
The findings of this study are expected to provide evidence regarding the predictive role of preoperative pain-related fear on postoperative pain outcomes and to inform the development of targeted perioperative nursing interventions aimed at optimizing pain management and enhancing recovery
- Conditions
- Cholecystectomy, Laparoscopic
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 Cholecystectomy | Adult patients scheduled for elective cholecystectomy who meet the eligibility criteria will be prospectively observed. Preoperative fear of postoperative pain and postoperative pain intensity will be assessed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Postoperative pain intensity will be measured using the Numeric Rating Scale (NRS), a validated 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.
Measured: 4, 12, and 24 hours postoperatively
Secondary outcomes (1)
Preoperative Fear of Postoperative Pain
Preoperative fear of postoperative pain will be assessed using the Postoperative Pain Fear Scale. The scale consists of 10 items scored from 0 to 10, with total scores ranging from 0 to 100. Higher scores indicate greater levels of fear related to postoperative pain
Measured: One day before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start15 Feb 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystectomy, LaparoscopicStudies 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
- 106 participants (estimated)
- Target duration
- 106 Years
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Akkaya, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457905
- Sponsor's protocol ID
- OKANU-SBÜ-SA-01
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE RELATIONSHIP BETWEEN PAIN ANXIETY AND POST-OPERATIVE PAIN IN PATIENTS UNDERGOING CHOLECYSTECTOMY SURGERY
- ClinicalTrials.gov ID
- NCT07457905
- Acronym / sponsor ID
- OKANU-SBÜ-SA-01
- Conditions
- Cholecystectomy, Laparoscopic
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 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.
This descriptive observational study aims to examine the relationship between preoperative fear of postoperative pain and postoperative pain intensity in patients undergoing cholecystectomy.
Postoperative pain is one of the most common and significant clinical problems following surgical procedures. Psychological factors such as anxiety and fear of pain are known to influence pain perception and recovery outcomes. Preoperative fear related to postoperative pain may increase perceived pain intensity and negatively affect the postoperative recovery process.
The study will be conducted in the general surgery clinics of a tertiary care hospital. A total of 106 adult patients scheduled for cholecystectomy will be included. Preoperative fear of postoperative pain will be assessed one day before surgery using the Postoperative Pain Fear Scale. Postoperative pain intensity will be evaluated using the Numeric Rating Scale at the 4th, 12th, and 24th hours after surgery.
The findings of this study are expected to contribute to a better understanding of the relationship between preoperative pain-related fear and postoperative pain severity, and to provide evidence to improve perioperative nursing care and pain management strategies.
Detailed description
Cholecystectomy is one of the most frequently performed surgical procedures worldwide for the management of cholelithiasis and acute or chronic cholecystitis. Although laparoscopic techniques have significantly reduced surgical trauma and enhanced recovery, postoperative pain remains a prevalent and clinically relevant problem. Inadequate pain control may impair early mobilization, respiratory function, wound healing, and overall recovery, potentially increasing morbidity and healthcare costs.
Postoperative pain is a multidimensional phenomenon influenced by both physiological and psychological factors. Among psychological determinants, preoperative fear of postoperative pain has been identified as a potential predictor of increased pain perception and adverse recovery outcomes. Fear-related cognitive processes may amplify central pain processing mechanisms, heighten pain sensitivity, and contribute to increased analgesic requirements. Despite growing evidence regarding the impact of psychological variables on surgical outcomes, the relationship between preoperative fear of postoperative pain and early postoperative pain intensity in patients undergoing cholecystectomy has not been sufficiently clarified.
This prospective descriptive observational study aims to investigate the association between preoperative fear of postoperative pain and postoperative pain intensity in adult patients undergoing elective cholecystectomy. The study will be conducted in the general surgery clinics of a tertiary care hospital. A total of 106 patients meeting the eligibility criteria will be consecutively recruited.
Preoperative fear of postoperative pain will be assessed one day prior to surgery using the Postoperative Pain Fear Scale. Postoperative pain intensity will be measured using the Numeric Rating Scale at the 4th, 12th, and 24th postoperative hours. Sociodemographic and clinical variables will also be collected to control for potential confounding factors.
Descriptive statistics will be used to summarize patient characteristics. The relationship between preoperative fear scores and postoperative pain intensity will be analyzed using correlation and regression analyses. A p-value of <0.05 will be considered statistically significant.
The findings of this study are expected to provide evidence regarding the predictive role of preoperative pain-related fear on postoperative pain outcomes and to inform the development of targeted perioperative nursing interventions aimed at optimizing pain management and enhancing recovery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 106 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Cholecystectomy | – | –Adult patients scheduled for elective cholecystectomy who meet the eligibility criteria will be prospectively observed. Preoperative fear of postoperative pain and postoperative pain intensity will be assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises adult patients undergoing elective cholecystectomy in the general surgery clinics of a tertiary care hospital. Consecutive eligible patients who meet the predefined inclusion criteria will be prospectively enrolled during the study period. The population represents surgical patients diagnosed primarily with cholelithiasis or cholecystitis.
Key inclusion criteria (1 listed)
- Adults aged 18 years and older Scheduled for elective cholecystectomy Able to speak and understand Turkish Conscious and able to complete questionnaires independently Voluntarily agree to participate in the study
Key exclusion criteria (1 listed)
- Use of anxiolytic medication Diagnosed psychiatric disorder that may affect pain perception Cognitive impairment preventing completion of study forms Emergency cholecystectomy Development of major postoperative complications requiring intensive care
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
Postoperative Pain Intensity
Time frame: 4, 12, and 24 hours postoperatively
Postoperative pain intensity will be measured using the Numeric Rating Scale (NRS), a validated 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.
1 secondary outcome
Preoperative Fear of Postoperative Pain
Time frame: One day before 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 9 Mar 2026.
- 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 Cholecystectomy, Laparoscopic, run by Okan 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 1 inclusion and 1 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 9 Mar 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 Seda AKKAYA, MSc (5057678339, sedakkaya@stu.okan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: 4, 12, and 24 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 9 Mar 2026.