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NCT Number: NCT07457905

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haydarpaşa Numune Trainingand Research Hospital

Istanbul, Turkey (Türkiye)

Location contact

SEDA AKKAYA, MSc

CONTACT

[email protected]

5057678339

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Seda AKKAYA, MSc

CONTACT

[email protected]

5057678339

ilknur çalışkan, phd

CONTACT

[email protected]

5367237207

Sponsors and collaborators

Lead sponsor

Okan University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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