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Recruiting NCT06785389

Influence of Preoperative Fear on Pain and Postoperative Outcomes

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fear of anesthesia, surgery and hospitals scale, State-Trait Anxiety Inventory, Nummerical Rating Scale for postoperative pain.
Who it may be relevant to
Registry conditions: Fear, Pain Management, Anxiety, Complications of Surgical Procedures or Medical Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Diagnostic test Fear of anesthesia, surgery and hospitals scale
    The day before surgery, patients will be interviewed using the scales of Fear of anesthesia, surgery and hospitals.
  • Diagnostic test State-Trait Anxiety Inventory
    The day before surgery, patients will be interviewed using the State-Trait Anxiety Inventory
  • Diagnostic test Nummerical Rating Scale for postoperative pain
    In the first postoperative day, patients will be monitored using the Nummerical Rating Scale, which will assess postoperative pain.

Primary outcome measures

  • Postoperative pain using Nummerical Rating Scale [Time frame: 24 hours]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Hospital Universitario de Gran Canaria Doctor Negrín — Las Palmas de Gran Canaria

Identifiers

NCT: NCT06785389 · 2024-472-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗