THE RELATIONSHIP BETWEEN PAIN ANXIETY AND POST-OPERATIVE PAIN IN PATIENTS UNDERGOING CHOLECYSTECTOMY SURGERY

March 3, 2026 updated by: Seda Akkaya, Okan University

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4, 12, and 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative Fear of Postoperative Pain
Time Frame: One day before surgery
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
One day before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • OKANU-SBÜ-SA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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