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Not yet recruiting NCT07457905

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

Observational Cholecystectomy, Laparoscopic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cholecystectomy, Laparoscopic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Primary outcome measures

  • Postoperative Pain Intensity [Time frame: 4, 12, and 24 hours postoperatively]
Secondary outcome measures (1)
  • Preoperative Fear of Postoperative Pain [Time frame: One day before surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Haydarpaşa Numune Trainingand Research Hospital — Istanbul

Identifiers

NCT: NCT07457905 · OKANU-SBÜ-SA-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗