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Not yet recruitingNCT07457905Updated Mar 9, 2026

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

An observational study in Cholecystectomy, Laparoscopic, sponsored by Okan University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by Okan University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
106
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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

02

Conditions studied

  • Cholecystectomy, Laparoscopic
03

In context

Lead sponsor

Okan University is the lead sponsor of 96 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
106 participants (estimated)
Target follow-up
106 Years
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: One day before surgery

07

Study locations

1 site
  • Haydarpaşa Numune Trainingand Research Hospital
    Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07457905
Lead sponsor
Okan University
Responsible party
Seda Akkaya (DOCTORAL STUDENT, Okan University) — Principal investigator
First posted
Mar 9, 2026
Start date
Feb 15, 2026 (estimated)
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Mar 9, 2026

Study contacts

Seda AKKAYA, MSc
Contact
sedakkaya@stu.okan.edu.tr
5057678339
ilknur çalışkan, phd
Contact
surgicalnursing@hotmail.com
5367237207

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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