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临床试验/NCT07394881
NCT07394881已完成不适用

Do Video Animations and 3-D Skull Models Reduce Preoperative Anxiety in Bimaxillary Orthognathic Surgery Patients? Single Blinded Randomized Controlled Trial

Ankara University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Visual Analogue Scale for Anxiety (VAS-A)

研究概览

简要总结

This study evaluates whether adding visual tools to standard preoperative counseling can reduce anxiety in patients scheduled for bimaxillary orthognathic surgery. Participants aged 18-36 years undergoing elective surgery was randomly assigned to one of three groups: (1) standard verbal information, (2) standard verbal information with a short animation video, (3) standard verbal information with a 3-D anatomical skull model demonstration. Anxiety was assessed using the State-Trait Anxiety Inventory and a visual analog scale at two time points: before the information session and approximately one hour before surgery. The goal is to determine whether visual tools provide additional benefit beyond standard counseling in reducing preoperative anxiety.

详细描述

This was a single-center, randomized, parallel-group study assessing the effect of different counseling tools on preoperative anxiety in patients undergoing elective bimaxillary orthognathic surgery. All participants received standardized verbal preoperative information delivered in a consistent setting. Group A received verbal information only; Group B received verbal information supplemented with an animation video; and Group C received verbal information supplemented with a 3-D anatomical skull model demonstration. Information sessions were standardized and lasted approximately 10 minutes. Anxiety was measured using the STAI (state and trait components) and a VAS at two predefined time points: baseline (before the information session) and approximately one hour before surgery. The main comparisons were changes in anxiety scores between groups to evaluate whether visual tools reduced preoperative anxiety beyond standard counseling. Data collection of anxiety assessments was performed by blinded personnel, and ethical approval and written informed consent were obtained.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessments were administered by blinded personnel who were not involved in delivering the information sessions.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (≥18 years).
  • Scheduled to undergo elective bimaxillary orthognathic surgery under general anesthesia.
  • Able to understand the study procedures and complete the anxiety questionnaires.
  • Provided written informed consent.

排除标准

  • Current diagnosis of a major psychiatric disorder or use of anxiolytic/antidepressant medication that could affect anxiety assessment.
  • Cognitive impairment or inability to complete the questionnaires.
  • Emergency surgery.
  • Refusal to participate or withdrawal of consent.
  • Any condition judged by the investigator to interfere with participation or outcome assessment.

研究组 & 干预措施

Control

Active Comparator

Standardized verbal preoperative information.

干预措施: Verbal İnformation (Behavioral)

Video Animation Tools

Experimental

animation video used as a visual tool during counseling.

干预措施: Animation Video Counseling (Behavioral)

3D-Head Skull Tools

Experimental

Anatomical skull model demonstration used as a visual tool during counseling.

干预措施: 3-D Skull Model Counseling (Behavioral)

结局指标

主要结局

Visual Analogue Scale for Anxiety (VAS-A)

时间窗: From baseline (before preoperative counseling) to immediately before surgery

Change in preoperative anxiety level measured using the Visual Analogue Scale for Anxiety (VAS-A). The scale ranges from 0 (no anxiety) to 100 (maximum anxiety).

State-Trait Anxiety Inventory

时间窗: From baseline (before preoperative counseling) to immediately before surgery

Change in state anxiety measured using the State subscale of the State-Trait Anxiety Inventory (STAI-S). The overall (total) score for STAI ranges from a minimum of 20 to a maximum of 80; STAI scores are commonly classified as 'no or low anxiety' (20-37), 'moderate anxiety' (38-44), and 'high anxiety' (45-80)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Uğur Boz

Oral and Maxillofacial Surgery Resident

Ankara University

研究点 (1)

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