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

NCT07457905 | Not Yet Recruiting DMC

• 1 other identifier: OKANU-SBÜ-SA-01
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholecystectomy, Laparoscopic

Outcome Measures

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.

  4, 12, and 24 hours postoperatively

Secondary Outcomes (1)

• Preoperative Fear of Postoperative Pain

  One day before surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Haydarpaşa Numune Trainingand Research Hospital

Istanbul, Turkey (Türkiye)

Location

Central Study Contacts

Seda AKKAYA, MSc

CONTACT

5057678339; sedakkaya@stu.okan.edu.tr

ilknur çalışkan, phd

CONTACT

5367237207; surgicalnursing@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 106 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOCTORAL STUDENT

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 9, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)