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NCT Number: NCT06785389

Influence of Preoperative Fear on Pain and Postoperative Outcomes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario de Gran Canaria Doctor Negrín

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

Location status: Recruiting

Location contact

Ángel Becerra-Bolaños, MD PhD

CONTACT

[email protected]

676229025

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

State-trait anxiety inventory

Diagnostic Test

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

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.

Other names: Nummerical Rating Scale

Primary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Aurelio Rodríguez-Pérez, MD PhD

CONTACT

[email protected]

+928450370

Ángel Becerra Bolaños, MD PhD

CONTACT

[email protected]

676229025

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Gran Canaria Doctor Negrín

Other

Registry information

Acronym: POSPoFe

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 21, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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