The Effect of Animation-Assisted Information Added to Standard Preoperative Information on Anxiety in Adolescents Undergoing Elective Surgery: A Multicenter Randomized Controlled Trial
Sponsor study identifier
interventional
148
0 countries
N/A
Study Start
November 2, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 22, 2026
Actual (reported)October 28, 2026
Actual (reported)November 2, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
From baseline in the preoperative waiting area (T0) to immediately before anesthesia induction in the operating room (T1), on the day of surgery.
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.
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.
First Submitted
October 22, 2026
First Posted
October 28, 2026
Study Start
November 2, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 1, 2027
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 28, 2026
Record last verified: 2026-10
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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Source: ClinicalTrials.gov.
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