Influence of Preoperative Fear on Pain and Postoperative Outcomes

NCT ID: NCT06785389

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-22

Study Completion Date

2025-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fear Pain Management Anxiety Complications of Surgical Procedures or Medical Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients scheduled for surgery

Patients undergoing surgery under general anesthesia with hospital admission.

Fear of anesthesia, surgery and hospitals scale

Intervention Type DIAGNOSTIC_TEST

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

State-Trait Anxiety Inventory

Intervention Type DIAGNOSTIC_TEST

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

Nummerical Rating Scale for postoperative pain

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

State-Trait Anxiety Inventory

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nummerical Rating Scale

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dr. Negrin University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ángel Becerra-Bolaños, MD PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ángel Becerra Bolaños, MD PhD

Role: CONTACT

676229025

Aurelio Rodríguez-Pérez, MD PhD

Role: CONTACT

+928450370

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ángel Becerra-Bolaños, MD PhD

Role: primary

676229025

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-472-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Improving Perioperative Sleep Disorders
NCT06512155 COMPLETED PHASE1