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

August 19, 2025 updated by: Ángel Becerra-Bolaños, MD PhD, Dr. Negrin University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Las Palmas
      • Las Palmas De Gran Canaria, Las Palmas, Spain, 35002
        • Recruiting
        • Hospital Universitario de Gran Canaria Doctor Negrín
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients scheduled for surgery
Patients undergoing surgery under general anesthesia with hospital admission.
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.
Other Names:
  • Nummerical Rating Scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain using Nummerical Rating Scale
Time Frame: 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)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Negrin University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

January 21, 2025

Study Record Updates

Last Update Posted (Actual)

August 24, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-472-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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