Preoperative AnxietyNCT07348497
Effects of Preoperative Education on Anxiety and Emergence Agitation
A study testing Preoperative Emergence-Focused Education and Standard Perioperative Care in people with Preoperative Anxiety and Emergence Agitation, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety, Emergence Agitation, Surgical Patients
- What is being tested?
- Preoperative Emergence-Focused Education and Standard Perioperative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2025to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan 2.Abdul Hamid Khan Educational and Research Hospital
Istanbul, Üsküdar
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- Preoperative Emergence-Focused Education, Standard Perioperative Care
- Keywords
- emergence agitation, anxiety, pain
- Medical subject headings
- Emergence Delirium, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Emergence-Focused EducationBehavioural
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 CareOther
Routine perioperative care provided according to institutional standards, including standard preoperative verbal information.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Perioperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: On the day of surgery, prior to induction of anesthesia
Secondary outcomes (1)
Postoperative Pain Intensity
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.
Measured: First 30 minutes after admission to the PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start12 Dec 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Saglik Bilimleri University
- Responsible party
- Principal investigator, İnci Kırtıl, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348497
- Sponsor's protocol ID
- 553868
- Status last verified
- Dec 2025
- First submitted
- 25 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Education on Preoperative Anxiety and Emergence Agitation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07348497
- Acronym / sponsor ID
- 553868
- Conditions
- Preoperative Anxiety, Emergence Agitation, Surgical Patients
- Keywords
- emergence agitation, anxiety, pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Collaborators
- Istanbul Saglik Bilimleri University
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Preoperative Emergence-Focused Education | Experimental | Behavioral: Preoperative Emergence-Focused EducationParticipants 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. |
| Control Group: Standard Perioperative Care | Active comparator | Other: Standard Perioperative CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Emergence-Focused EducationA 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. | Behavioural | Experimental Group: Preoperative Emergence-Focused Education |
| Standard Perioperative CareRoutine perioperative care provided according to institutional standards, including standard preoperative verbal information. | Other | Control Group: Standard Perioperative Care |
Primary outcome
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).
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.
1 secondary outcome
Postoperative Pain Intensity
Time frame: First 30 minutes after admission to the PACU
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy and confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Emergence-Focused Education and Standard Perioperative Care in people with Preoperative Anxiety and Emergence Agitation, run by Yeditepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Emergence Agitation (time frame: First 30 minutes after admission to the post-anesthesia care unit (PACU)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.