Preoperative AnxietyNCT07901231
Effect of Animation-Assisted Preoperative Information on Anxiety in Adolescents Undergoing Elective Surgery
A study testing Animation-Assisted Preoperative Information in people with Preoperative Anxiety, run by Ankara City Hospital Bilkent.
Trial summary
This study aims to find out whether adding a short educational animation to standard preoperative information can help reduce anxiety in adolescents aged 12-17 years who are scheduled for elective surgery. A total of 148 adolescents will participate in this randomized controlled study. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- Animation-Assisted Preoperative Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2026to 2 May 2027
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescents aged 12-17 years
- Scheduled to undergo elective surgery under anesthesia
- American Society of Anesthesiologists (ASA) physical status I or II
- Ability to understand Turkish and complete self-reported anxiety assessments
- Written informed consent from a parent or legal guardian and assent from the adolescent
Who cannot join
- Emergency surgery
- ASA physical status III or higher
- Cognitive or communication impairment preventing completion of anxiety assessments
- Inability to understand Turkish
- Administration of sedative or anxiolytic medication before completion of the preoperative anxiety assessments
- Refusal to participate or withdrawal of consent
About this study
Official title: The Effect of Animation-Assisted Information Added to Standard Preoperative Information on Anxiety in Adolescents Undergoing Elective Surgery: A Multicenter Randomized Controlled Trial
This study aims to find out whether adding a short educational animation to standard preoperative information can help reduce anxiety in adolescents aged 12-17 years who are scheduled for elective surgery.
A total of 148 adolescents will participate in this randomized controlled study. Participants will be randomly assigned to one of two groups. The first group will receive standard verbal and written information about anesthesia. The second group will receive the same information along with an age-appropriate educational animation explaining what to expect before, during, and after anesthesia.
Read more
Participants will be asked to rate their anxiety before receiving information in the preoperative waiting area and again in the operating room before receiving any sedative medication or anesthesia. The researchers will compare how anxiety levels change between the two groups.
The study will also assess heart rate, blood pressure, parental anxiety, satisfaction with the information provided, and adolescents' feelings about their upcoming surgery.
The findings may help healthcare professionals improve the way adolescents and their families are prepared for anesthesia and surgery.
- Conditions
- Preoperative Anxiety
- Being tested
- Animation-Assisted Preoperative Information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animation-Assisted Preoperative InformationBehavioural
Participants allocated to the intervention group will receive standard verbal and written preoperative anesthesia information supplemented by a standardized, age-appropriate educational animation.
The animation will explain the perioperative process, including preparation before surgery, transfer to the operating room, anesthesia administration, and recovery after anesthesia, using clear and reassuring language suitable for adolescents aged 12-17 years.
The animation will be presented in the preoperative waiting area before administration of any sedative or anxiolytic medication. Participants in the control group will receive standard verbal and written preoperative information without the animation.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: control group | No intervention | Not described |
| Arm 2: Animation-Assisted Preoperative Information | Experimental | Participants in this group will receive standard verbal and written preoperative anesthesia information supplemented with a standardized, age-appropriate educational animation. The animation will be presented in the preoperative waiting area before administration of sedative or anxiolytic medication. Preoperative anxiety will be assessed before and after the educational intervention. Receives: Behavioral: Animation-Assisted Preoperative Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Preoperative Anxiety Score (VAS-A) From Baseline to Pre-Induction
Adolescent preoperative anxiety will be assessed using a self-reported Visual Analog Scale for Anxiety (VAS-A), ranging from 0 (no anxiety) to 10 (maximum anxiety). Anxiety will be measured at two time points: T0, in the preoperative waiting area before the educational intervention, and T1, on the operating room table before administration of sedative medication or anesthesia induction. The primary outcome will be the between-group difference in the change in VAS-A scores (T1 minus T0). Lower scores indicate less anxiety, and a negative change indicates a reduction in anxiety.
Measured: From baseline in the preoperative waiting area (T0) to immediately before anesthesia induction in the operating room (T1), on the day of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion2 May 2027 (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.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep KÖKSAL, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901231
- Sponsor's protocol ID
- E2-26-16671
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations involving adolescent participants. Study results will be reported in aggregate form in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Animation-Assisted Information Added to Standard Preoperative Information on Anxiety in Adolescents Undergoing Elective Surgery: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07901231
- Acronym / sponsor ID
- E2-26-16671
- Conditions
- Preoperative Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 2 May 2027 (estimated)
- First posted
- 28 Oct 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 study aims to find out whether adding a short educational animation to standard preoperative information can help reduce anxiety in adolescents aged 12-17 years who are scheduled for elective surgery.
A total of 148 adolescents will participate in this randomized controlled study. Participants will be randomly assigned to one of two groups. The first group will receive standard verbal and written information about anesthesia. The second group will receive the same information along with an age-appropriate educational animation explaining what to expect before, during, and after anesthesia.
Participants will be asked to rate their anxiety before receiving information in the preoperative waiting area and again in the operating room before receiving any sedative medication or anesthesia. The researchers will compare how anxiety levels change between the two groups.
The study will also assess heart rate, blood pressure, parental anxiety, satisfaction with the information provided, and adolescents' feelings about their upcoming surgery.
The findings may help healthcare professionals improve the way adolescents and their families are prepared for anesthesia and surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: control group | No intervention | – |
| Arm 2: Animation-Assisted Preoperative Information | Experimental | Behavioral: Animation-Assisted Preoperative InformationParticipants in this group will receive standard verbal and written preoperative anesthesia information supplemented with a standardized, age-appropriate educational animation. The animation will be presented in the preoperative waiting area before administration of sedative or anxiolytic medication. Preoperative anxiety will be assessed before and after the educational intervention. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Adolescents aged 12-17 years
- Scheduled to undergo elective surgery under anesthesia
- American Society of Anesthesiologists (ASA) physical status I or II
- Ability to understand Turkish and complete self-reported anxiety assessments
- Written informed consent from a parent or legal guardian and assent from the adolescent
Key exclusion criteria (6 listed)
- Emergency surgery
- ASA physical status III or higher
- Cognitive or communication impairment preventing completion of anxiety assessments
- Inability to understand Turkish
- Administration of sedative or anxiolytic medication before completion of the preoperative anxiety assessments
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 |
|---|---|---|
| Animation-Assisted Preoperative InformationParticipants allocated to the intervention group will receive standard verbal and written preoperative anesthesia information supplemented by a standardized, age-appropriate educational animation. The animation will explain the perioperative process, including preparation before surgery, transfer to the operating room, anesthesia administration, and recovery after anesthesia, using clear and reassuring language suitable for adolescents aged 12-17 years. The animation will be presented in the preoperative waiting area before administration of any sedative or anxiolytic medication. Participants in the control group will receive standard verbal and written preoperative information without the animation. | Behavioural | Arm 2: Animation-Assisted Preoperative Information |
Primary outcome
Change in Preoperative Anxiety Score (VAS-A) From Baseline to Pre-Induction
Time frame: From baseline in the preoperative waiting area (T0) to immediately before anesthesia induction in the operating room (T1), on the day of surgery.
Adolescent preoperative anxiety will be assessed using a self-reported Visual Analog Scale for Anxiety (VAS-A), ranging from 0 (no anxiety) to 10 (maximum anxiety). Anxiety will be measured at two time points: T0, in the preoperative waiting area before the educational intervention, and T1, on the operating room table before administration of sedative medication or anesthesia induction. The primary outcome will be the between-group difference in the change in VAS-A scores (T1 minus T0). Lower scores indicate less anxiety, and a negative change indicates a reduction in anxiety.
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 30 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations involving adolescent participants. Study results will be reported in aggregate form in scientific publications.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Animation-Assisted Preoperative Information in people with Preoperative Anxiety, run by Ankara City Hospital Bilkent.
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 6 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Preoperative Anxiety Score (VAS-A) From Baseline to Pre-Induction (time frame: From baseline in the preoperative waiting area (T0) to immediately before anesthesia induction in the operating room (T1), on the day of surgery.). 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 30 Oct 2026.