- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07348497
Effects of Preoperative Education on Anxiety and Emergence Agitation
The Effect of Preoperative Education on Preoperative Anxiety and Emergence Agitation: A Randomized Controlled Trial
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Üsküdar
-
Istanbul, Üsküdar, Turkey (Türkiye)
- Sultan 2.Abdul Hamid Khan Educational and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Active Comparator: 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.
|
Routine perioperative care provided according to institutional standards, including standard preoperative verbal information.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
First 30 minutes after admission to the post-anesthesia care unit (PACU)
|
|
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.
|
On the day of surgery, prior to induction of anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
First 30 minutes after admission to the PACU
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 553868
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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