Effects of Preoperative Education on Anxiety and Emergence Agitation

NCT ID: NCT07348497

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-12
• Study Completion Date: 2026-07-15

Brief Summary

This randomized controlled trial aims to evaluate the effect of structured preoperative education focused on the anesthesia emergence process on preoperative anxiety and postoperative emergence agitation in adult surgical patients undergoing general anesthesia. Emergence agitation is a frequent postoperative complication associated with patient discomfort, safety risks, and increased clinical workload. Preoperative anxiety is considered a modifiable risk factor for emergence agitation; however, evidence-based educational interventions targeting the emergence phase are limited.

The intervention consists of a standardized, nurse-led preoperative education program providing information on general anesthesia, endotracheal intubation and extubation, the post-anesthesia care unit environment, and expected physical and emotional responses during emergence. Education is delivered through a face-to-face individual session supported by written materials. Patients in the control group receive routine perioperative verbal information in accordance with standard care.

Eligible adult patients scheduled for elective general surgery under general anesthesia will be randomly assigned to either the intervention or control group. Preoperative anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Emergence agitation will be evaluated in the post-anesthesia care unit using the Riker Sedation-Agitation Scale (SAS) and the Richmond Agitation-Sedation Scale (RASS) during the first 30 minutes after surgery.

The primary outcomes are preoperative anxiety levels and the incidence of postoperative emergence agitation. Secondary outcomes include postoperative pain, extubation time and quality, and length of stay in the post-anesthesia care unit. This study seeks to determine whether emergence-focused preoperative education can improve perioperative psychological outcomes and enhance patient safety in surgical care.

Detailed Description

This randomized controlled trial is designed to systematically evaluate the effect of structured preoperative education focused on the anesthesia emergence process on preoperative anxiety and postoperative emergence agitation in adult surgical patients undergoing general anesthesia. Emergence agitation is a common and clinically significant phenomenon in the immediate postoperative period and is associated with patient distress, safety risks, increased workload for healthcare professionals, and potential complications. Preoperative anxiety has been identified as a key modifiable risk factor contributing to emergence agitation; however, evidence-based educational interventions specifically targeting the emergence phase remain limited. The intervention consists of a standardized, nurse-led preoperative education program that provides patients with detailed information about the anesthesia emergence process. Educational content includes explanations of general anesthesia, endotracheal intubation and extubation procedures, the physical environment of the post-anesthesia care unit (PACU), expected physiological, emotional, and behavioral responses during emergence, and the typical duration and monitoring of the recovery process. Education is delivered in a face-to-face individual session lasting approximately 10-15 minutes and is supported by a written patient education brochure to ensure consistency and comprehension. Participants will be adult patients (≥18 years) scheduled for elective general surgery under general anesthesia at a tertiary training and research hospital. Eligible patients who provide informed consent and meet inclusion criteria will be randomly assigned to either the intervention group or the control group. Randomization will be performed using a computer-generated random sequence. The control group will receive routine perioperative verbal information in accordance with standard clinical practice, while the intervention group will receive routine care plus the structured emergence-focused education. Preoperative anxiety will be assessed on the day of surgery prior to anesthesia induction using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Postoperative emergence agitation will be evaluated in the PACU using the Riker Sedation-Agitation Scale (SAS) and the Richmond Agitation-Sedation Scale (RASS). Agitation assessments will be conducted at 10-minute intervals during the first 30 minutes following admission to the PACU, and the highest recorded score will be used for analysis. Emergence agitation will be defined as a SAS score ≥5 and/or a RASS score ≥+1. The primary outcomes of the study are the incidence and severity of emergence agitation and preoperative anxiety levels. Secondary outcomes include maximum postoperative pain scores in the PACU, time to extubation, extubation quality, and length of stay in the PACU. Demographic, clinical, and perioperative variables will be collected using a structured patient information form.

Conditions

Preoperative Anxiety; Emergence Agitation; Surgical Patients

Study Design

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

Study Groups

Experimental Group: Preoperative Emergence-Focused Education

Participants in this group will receive routine perioperative care plus a structured, nurse-led preoperative education program focused on the anesthesia emergence process. The education includes information on general anesthesia, endotracheal intubation and extubation, the post-anesthesia care unit environment, and expected physical, emotional, and behavioral responses during emergence. Education is delivered individually in a face-to-face session lasting approximately 10-15 minutes and is supported by written educational materials.

Group Type: EXPERIMENTAL

Preoperative Emergence-Focused Education

Intervention Type: BEHAVIORAL

A standardized preoperative educational intervention delivered by trained nurses to increase patients' understanding of the anesthesia emergence process and to reduce preoperative anxiety and postoperative emergence agitation. The intervention is provided before surgery through verbal education and written materials.

Control Group: Standard Perioperative Care

Participants in this group will receive routine preoperative and perioperative care in accordance with institutional clinical practice, including standard verbal information about the surgical and anesthesia process, without additional emergence-focused education.

Group Type: ACTIVE_COMPARATOR

Standard Perioperative Care

Intervention Type: OTHER

Routine perioperative care provided according to institutional standards, including standard preoperative verbal information.

Interventions

Preoperative Emergence-Focused Education

A standardized preoperative educational intervention delivered by trained nurses to increase patients' understanding of the anesthesia emergence process and to reduce preoperative anxiety and postoperative emergence agitation. The intervention is provided before surgery through verbal education and written materials.

Intervention Type: BEHAVIORAL

Standard Perioperative Care

Routine perioperative care provided according to institutional standards, including standard preoperative verbal information.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18 years or older
• Scheduled for elective general surgery under general anesthesia
• American Society of Anesthesiologists (ASA) physical status I-III
• Able to comprehend the educational intervention
• Willing and able to provide written informed consent

Exclusion Criteria

• History of neurological disorders, cognitive impairment, or dementia
• Severe psychiatric illness or current use of antipsychotic medications
• Alcohol or substance use disorder
• Sensory impairments (visual, hearing, or speech) that may interfere with communication

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Saglik Bilimleri University

OTHER

Sponsor Role: collaborator

Yeditepe University

OTHER

Sponsor Role: lead

Responsible Party

İnci Kırtıl

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sultan 2.Abdul Hamid Khan Educational and Research Hospital

Istanbul, Üsküdar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

553868

Identifier Type: -

Identifier Source: org_study_id