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Influence of Preoperative Fear on Pain and Postoperative Outcomes (POSPoFe)

D

Dr. Negrin University Hospital

Status

Enrolling

Conditions

Fear
Complications of Surgical Procedures or Medical Care
Pain Management
Anxiety

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT06785389
2024-472-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

138 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

138 participants in 1 patient group

Patients scheduled for surgery
Description:
Patients undergoing surgery under general anesthesia with hospital admission.
Treatment:
Diagnostic Test: Fear of anesthesia, surgery and hospitals scale
Diagnostic Test: Nummerical Rating Scale for postoperative pain
Diagnostic Test: State-Trait Anxiety Inventory

Trial contacts and locations

1

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Central trial contact

Ángel Becerra Bolaños, MD PhD; Aurelio Rodríguez-Pérez, MD PhD

Data sourced from clinicaltrials.gov

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