Effects of Preoperative Education on Anxiety and Emergence Agitation

NCT07348497 | Active Not Recruiting

• 1 other identifier: 553868
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Preoperative Anxiety; Emergence Agitation; Surgical Patients

Keywords

emergence agitation; anxiety; pain

Outcome Measures

Primary Outcomes (2)

• Incidence of Emergence Agitation

  Patients' emergence agitation will be assessed using the Riker Sedation-Agitation Scale (SAS) and the Richmond Agitation-Sedation Scale (RASS). Patients with a maximum SAS score ≥5 and RASS score ≥ +1 will be considered positive agitation (the highest score within the first 30 minutes will be taken into account).

  First 30 minutes after admission to the post-anesthesia care unit (PACU)

• Preoperative Anxiety Level

  Patients' preoperative anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Higher scores on the scale will be considered indicative of increased anxiety.

  On the day of surgery, prior to induction of anesthesia

Secondary Outcomes (1)

• Postoperative Pain Intensity

  First 30 minutes after admission to the PACU

Study Arms (2)

Experimental Group: Preoperative Emergence-Focused Education

EXPERIMENTAL

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.

Behavioral: Preoperative Emergence-Focused Education

Control Group: Standard Perioperative Care

ACTIVE COMPARATOR

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.

Other: Standard Perioperative Care

Interventions

Preoperative Emergence-Focused Education 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.

Experimental Group: Preoperative Emergence-Focused Education

Standard Perioperative Care OTHER

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

Control Group: Standard Perioperative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeditepe University: lead
• Istanbul Saglik Bilimleri University: collaborator

Study Sites (1)

Sultan 2.Abdul Hamid Khan Educational and Research Hospital

Istanbul, Üsküdar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence Delirium; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 16, 2026
• Study Start: December 12, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)