Influence of Preoperative Fear on Pain and Postoperative Outcomes

Recruiting

• Conditions: Fear; Pain Management; Anxiety; Complications of Surgical Procedures or Medical Care

• Registration Number: NCT06785389
• Lead Sponsor: Dr. Negrin University Hospital

Brief Summary

Fear of anesthesia plays a crucial role in the perioperative setting and can negatively affect recovery. The main objective is to assess the relationship between fear of anesthesia, surgeries, and hospitals and poorer postoperative pain control in patients undergoing scheduled surgery, as well as to relate preoperative anxiety to postoperative analgesic assessment in this population.

This is a prospective observational study including 138 patients scheduled for surgery.

Detailed Description

Fear is a response that arises in the face of immediate threats, such as medical procedures, while anxiety is related to uncertainty about treatment and prognosis. These factors can negatively affect recovery. Assessing anxiety levels using specific tools may be essential to predict clinical outcomes and facilitate patient recovery after surgery.

This prospective observational study will assess the relationship between fear of anesthesia, surgeries, and hospitals and poorer postoperative pain control in patients undergoing scheduled surgery. It will also relate preoperative anxiety to postoperative analgesic assessment in this population.

Disease or disorder under study: Fear of anesthesia and postoperative pain control using two preoperative questionnaires. Patients will be followed up until discharge to assess postoperative pain and postoperative outcomes. Considering that the estimated percentage of fear is around 10%, with a 95% confidence interval and a 5% error margin, 138 patients are needed to accurately estimate its prevalence in the population.

Study Timeline

• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-16
• Study First Posted: 2025-01-21
• Study Start: 2025-01-22
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-19
• Last Update Posted: 2025-08-24
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• All patients older than 18 years old scheduled for surgery with admission during the study period will be included.
• Verbal and written informed consent.

Exclusion Criteria

• Minors
• Cognitive impairment
• Patients not being able to understand and respond to preoperative questionnaires
• Patients not being able to respond to postoperative pain assessment
• Patients not giving informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain using Nummerical Rating Scale	24 hours	In the first postoperative day, patients will be monitored using the Nummerical Rating Scale, which will assess postoperative pain, from 0 (no pain) to 10 (maximum pain)

Trial Locations

Locations (1)

Hospital Universitario de Gran Canaria Doctor Negrín; 🇪🇸 Las Palmas De Gran Canaria, Las Palmas, Spain