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NCT Number: NCT07348497

Effects of Preoperative Education on Anxiety and Emergence Agitation

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sultan 2.Abdul Hamid Khan Educational and Research Hospital

Istanbul, Üsküdar, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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.

Standard Perioperative Care

Other

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

Primary outcomes

  1. Incidence of Emergence Agitation

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

    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).

  2. Preoperative Anxiety Level

    Time frame: On the day of surgery, prior to induction of anesthesia

    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.

Secondary outcomes

  1. Postoperative Pain Intensity

    Time frame: First 30 minutes after admission to the PACU

    Patients' pain intensity will be assessed using an 11-point numerical rating scale. A score of 0 will indicate that the patient has no pain at all, while a score of 10 will indicate the most severe pain experienced to date. The highest pain score recorded within the first 30 minutes will be considered.

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Collaborators

  • Istanbul Saglik Bilimleri University

Registry information

Official study title

The Effect of Preoperative Education on Preoperative Anxiety and Emergence Agitation: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

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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