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Not yet recruitingNCT07901231Updated Oct 30, 2026

Effect of Animation-Assisted Preoperative Information on Anxiety in Adolescents Undergoing Elective Surgery

An interventional study of Animation-Assisted Preoperative Information in Preoperative Anxiety, sponsored by Ankara City Hospital Bilkent. Not yet recruiting. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Supportive care

Updated Oct 30, 2026Eligibility revisedTitle changed+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Preoperative Anxiety
03

In context

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 443 studies on the registry; 111 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 30, 2026. See what changed

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adolescents aged 12-17 years
  • Scheduled to undergo elective surgery under anesthesia
  • (ASA) physical status I or II
  • Ability to understand Turkish and complete self-reported anxiety assessments
  • Written from a parent or legal guardian and assent from the adolescent

Exclusion criteria

Exclusion Criteria:

  • Emergency surgery
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
148 participants (estimated)

Study arms

  • No intervention
    Arm 1: control group
  • Experimental
    Arm 2: Animation-Assisted Preoperative Information

    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.

    Behavioral: Animation-Assisted Preoperative Information

Interventions

  • BehavioralAnimation-Assisted Preoperative Information

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Eligibility
3 inclusion criteria edited, 1 removed; 4 exclusion criteria edited
What changed in the criteria
Inclusion criteria
  • EditedAmerican Society of Anesthesiologists (ASA) physical status I- or II.
  • RemovedAbility to understand and communicate in Turkish.
  • EditedAbility to understand Turkish and complete the self-reported anxiety assessment scales.assessments
  • EditedWritten informed consent from a parent or legal guardian and written assent from the adolescent.
Exclusion criteria
  • ChangedBefore Emergency surgical procedures.Now Emergency surgery
  • EditedCognitive impairment or communication difficulties that prevent reliableimpairment preventing completion of anxiety assessments.
  • EditedAdministration of sedative or anxiolytic medication before completion of the T1preoperative anxiety assessment.assessments
  • EditedRefusal to participate or withdrawal of consent or assent.
Oct 30, 2026
Title
Effect of Animation-Assisted Preoperative Information on Anxiety in Adolescents: A Multicenter Randomized Controlled Trial Undergoing Elective Surgery
Oct 30, 2026
Registered
First appeared on the registry
Oct 28, 2026
Show all 2 updates
  1. Oct 30, 2026
    Eligibility 3 inclusion criteria edited, 1 removed; 4 exclusion criteria edited
    What changed in the criteria
    Inclusion criteria
    • EditedAmerican Society of Anesthesiologists (ASA) physical status I- or II.
    • RemovedAbility to understand and communicate in Turkish.
    • EditedAbility to understand Turkish and complete the self-reported anxiety assessment scales.assessments
    • EditedWritten informed consent from a parent or legal guardian and written assent from the adolescent.
    Exclusion criteria
    • ChangedBefore Emergency surgical procedures.Now Emergency surgery
    • EditedCognitive impairment or communication difficulties that prevent reliableimpairment preventing completion of anxiety assessments.
    • EditedAdministration of sedative or anxiolytic medication before completion of the T1preoperative anxiety assessment.assessments
    • EditedRefusal to participate or withdrawal of consent or assent.
    Title Effect of Animation-Assisted Preoperative Information on Anxiety in Adolescents: A Multicenter Randomized Controlled Trial Undergoing Elective Surgery
  2. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07901231
Responsible party
Zeynep KÖKSAL (anesthesiology and reanimation specialist, Ankara City Hospital Bilkent) — Principal investigator
First posted
Oct 28, 2026
Start date
Nov 2, 2026 (estimated)
Primary completion
Apr 1, 2027 (estimated)
Completion
May 2, 2027 (estimated)
Last update
Oct 30, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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