Impact of Pre-anesthetic Evaluation on the Anxiety

NCT ID: NCT07032012

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-09-30

Brief Summary

Since the last century, it has been understood that "the pre-anesthetic evaluation is the patient's right and the anesthesiologist's duty." As early as 2006, the Conselho Federal de Medicina (CFM) published a resolution addressing the anesthetic act and guiding the conduct of pre-anesthetic evaluation (PAE) and in 2017 revised these guidelines in a new resolution. The PAE is an important step in preparing the patient for elective surgical procedures. It refers to the moment when the anesthesiologist and patient have the opportunity to get to know each other, optimize the patient's clinical conditions and even request exams or consult other specialists when necessary. The prevalence and levels of anxiety, commonly generated by the expectation of the surgical-anesthetic procedure, tend to reduce with the PAE. This leads to fewer patients presenting to the operating room with arterial hypertension or arrhythmia, which are triggered by anxiety. It can be said that the implementation of the PAE directs screening processes and consequently reduces the patient's risk to unnecessary procedures or consultations. It also highlights the reduction in perioperative morbidity and mortality rates. By analyzing the dynamics of the surgical center, where the space is highly technological and contested by various surgical specialties, it is possible to associate the PAE with the reduction in cancellation rates of procedures and the proper use of space. Measuring sentiment is difficult and to assess anxiety, one can use complex questionnaires to small and objective scales. Some studies show how anxiety can contribute to increased postoperative pain, higher medication consumption, and longer hospitalization time. A possible tool to change this scenario would be the PAE, but its relationship with anxiety still needs to be further documented, especially in Brazil. Therefore, this project seeks to study the hypothesis that the PAE reduces anxiety levels, brings quality to the anesthetic-surgical experience, and improves perioperative morbidity indicators. This study aims to evaluate the impact of pre-anesthetic evaluation on perioperative surgical outcomes in patients of the orthopedic specialty undergoing procedures at the institution. It aims to identify the anxiety level of patients undergoing orthopedic surgery. This randomized clinical trial will be conducted at the Hospital de Base do Distrito Federal, Brasília, Distrito Federal, Brazil.

Conditions

Anxiety; Postoperative Care; Preoperative Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

control - anxiety evaluation before Pre-anesthetic

If allocated to the group control, the anxiety questionnaire will be applied, and then the pre-anesthetic evaluation will be conducted.

Group Type: OTHER

control - anxiety evaluation before Pre-anesthetic

Intervention Type: OTHER

If allocated to the group control, the anxiety questionnaire will be applied, and then the pre-anesthetic evaluation will be conducted.

group intervention - anxiety evaluation after Pre-anesthetic

Intervention Type: OTHER

If allocated to the group intervention, the first contact of the participant with the interviewer will be on the eve of surgery, in the ward. At that moment, the pre-anesthetic evaluation will be conducted. The next day, upon admission to the preoperative room, the anxiety questionnaire will be applied.

intervention - anxiety evaluation after Pre-anesthetic

If allocated to the group intervention, the first contact of the participant with the interviewer will be on the eve of surgery, in the ward. At that moment, the pre-anesthetic evaluation will be conducted. The next day, upon admission to the preoperative room, the anxiety questionnaire will be applied.

Group Type: ACTIVE_COMPARATOR

control - anxiety evaluation before Pre-anesthetic

Intervention Type: OTHER

If allocated to the group control, the anxiety questionnaire will be applied, and then the pre-anesthetic evaluation will be conducted.

group intervention - anxiety evaluation after Pre-anesthetic

Intervention Type: OTHER

If allocated to the group intervention, the first contact of the participant with the interviewer will be on the eve of surgery, in the ward. At that moment, the pre-anesthetic evaluation will be conducted. The next day, upon admission to the preoperative room, the anxiety questionnaire will be applied.

Interventions

control - anxiety evaluation before Pre-anesthetic

If allocated to the group control, the anxiety questionnaire will be applied, and then the pre-anesthetic evaluation will be conducted.

Intervention Type: OTHER

group intervention - anxiety evaluation after Pre-anesthetic

If allocated to the group intervention, the first contact of the participant with the interviewer will be on the eve of surgery, in the ward. At that moment, the pre-anesthetic evaluation will be conducted. The next day, upon admission to the preoperative room, the anxiety questionnaire will be applied.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• elective or urgent orthopedic surgery
• aged between 18 and 65 years
• ASA classification I to III

Exclusion Criteria

• Patient refusal to participate
• Patient refusal to sign the IC
• Lack of education
• History of psychiatric illness, especially depression
• Limited cognitive capacity (self-declared or informed by a companion)
• Prolonged hospitalization (greater than or equal to 14 days)
• Emergency surgery
• Inability to understand the IC.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Base

OTHER

Sponsor Role: lead

Responsible Party

Fabricio Tavares Mendonca

MD, TSA, MSc, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Iuri Ferreira Lopes Iuri Ferreira Lopes, MD

Role: CONTACT

iuri_fl@hotmail.com

+55 (61) 99620-6361

References

Ambulkar R, Patel A, Patil S, Savarkar S. Patient satisfaction with anaesthesia services in a tertiary care cancer centre. (SAY study). J Anaesthesiol Clin Pharmacol. 2022 Jan-Mar;38(1):111-117. doi: 10.4103/joacp.JOACP_187_20. Epub 2022 Jan 12.

Reference Type: BACKGROUND

PMID: 35706652 (View on PubMed)

Other Identifiers

iPAEonAnx

Identifier Type: -

Identifier Source: org_study_id