Influence of Preoperative Fear on Pain and Postoperative Outcomes

NCT06785389 | Recruiting

• 1 other identifier: 2024-472-1
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

preoperative fear; postoperative pain; postoperative outcomes; preoperative anxiety

Outcome Measures

Primary Outcomes (1)

• Postoperative pain using Nummerical Rating Scale

  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)

  24 hours

Study Arms (1)

Patients scheduled for surgery

Patients undergoing surgery under general anesthesia with hospital admission.

Diagnostic Test: Fear of anesthesia, surgery and hospitals scale; Diagnostic Test: State-Trait Anxiety Inventory; Diagnostic Test: Nummerical Rating Scale for postoperative pain

Interventions

Fear of anesthesia, surgery and hospitals scale DIAGNOSTIC_TEST

The day before surgery, patients will be interviewed using the scales of Fear of anesthesia, surgery and hospitals.

Patients scheduled for surgery

State-Trait Anxiety Inventory DIAGNOSTIC_TEST

The day before surgery, patients will be interviewed using the State-Trait Anxiety Inventory

Patients scheduled for surgery

Nummerical Rating Scale for postoperative pain DIAGNOSTIC_TEST

In the first postoperative day, patients will be monitored using the Nummerical Rating Scale, which will assess postoperative pain.

Also known as: Nummerical Rating Scale

Patients scheduled for surgery

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

All patients undergoing scheduled surgery with general anesthesia requiring hospital admission during the study period.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Negrin University Hospital: lead

Study Sites (1)

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, 35002, Spain

RECRUITING

MeSH Terms

Conditions

Agnosia; Anxiety Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Postoperative Complications; Pathologic Processes; Pain

Central Study Contacts

Ángel Becerra Bolaños, MD PhD

CONTACT

676229025; angbecbol@gmail.com

Aurelio Rodríguez-Pérez, MD PhD

CONTACT

+928450370; arodperp@gobiernodecanarias.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 21, 2025
• Study Start: January 22, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 15, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

ES (1)