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临床试验/NCT03889691
NCT03889691已完成不适用

Does Watching Video Increase the Perioperative Anxiety in Patients Undergoing Third Molar Surgery

T.C. ORDU ÜNİVERSİTESİ1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2018年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
113
试验地点
1
主要终点
Anxiety change being assessed with Spielberger State Anxiety Inventory (STAI-S)

研究概览

简要总结

Third molar extraction is the most common surgical procedure in the field of oral and maxillofacial surgery and usually cause anxiety. Although different informed consent methods have been used previously, the most effective information method that provide the optimum anxiety management is still not clear. Therefore, investigators planned a clinical study to explore the effect of different information formats (verbal information with written document and verbal information with written document subsequent to watching video from internet) on peri-operative anxiety of the participants who scheduled to undergo impacted lower third molar surgery. Also, investigators aimed to explore the effect internet usage before the third molar surgery on the level of anxiety.

详细描述

The participants were randomly divided into two groups. The control group consisted of participants who informed verbally about the surgical procedure and the potential postoperative complications,. Also, a written informed consent document was given. Participants in the study group were asked to watch a video which was previously uploaded to the internet and was showed procedural details of an impacted right lower third molar extraction (with permission and written consent). Participants in the study group were also informed verbally about the surgical procedure-possible postoperative complications and was given with a written informed consent document. In both groups questions of the participants were answered by the same surgeon. To evaluate anxiety; participants were asked to complete 3 questionnaires one week before the procedure when taking appointment for surgery, just after watching video or informed verbally, immediately after the procedure and one week after the procedure.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • without systemic disease,
  • have indication for third molar extraction,
  • radiographic degree of impaction according to the classification of Winter (vertical and mesio-angular) and the classification of Pell and Gregory 2, or 3 and B

排除标准

  • patients who;
  • has psychiatric illness and systemic disease,
  • refused to watch the video,
  • failed to fill out the forms for any reason,
  • had incomplete data and wanted to withdraw from the study,
  • had underwent a previous third molar surgery,
  • had history of anxiety attacks and/or anxiolytic treatment,
  • had unpleasant dental treatment experience could not cooperated,

结局指标

主要结局

Anxiety change being assessed with Spielberger State Anxiety Inventory (STAI-S)

时间窗: one week before the procedure when taking appointment for surgery, just after watching video or informed verbally, immediately after the procedure and one week after the procedure

There are total 40 questions in STAI-S (20). For each question the patients score ranged from 1 (almost never) to 4 (almost always) points. The sum of the scores range from 20-80. The score between 36 to 41 refer the mean anxiety level, and the values above 41 classified as high level of anxiety.

Anxiety change being assessed with Modified Dental Anxiety Scale (MDAS)

时间窗: one week before the procedure when taking appointment for surgery, just after watching video or informed verbally, immediately after the procedure and one week after the procedure

MDAS consists of five questions in total which measures anxiety at different stages of dental treatment. 1 (no anxious) to 5 (very anxious) options are available for each question. The sum of the scores varies from 5 to 25 and the values between 19-25 indicates high dental anxiety.

Anxiety change being assessed with Amsterdam Preoperative Anxiety Inventory (APAIS)

时间窗: one week before the procedure when taking appointment for surgery, just after watching video or informed verbally, immediately after the procedure and one week after the procedure

APAIS is a scale consisting of 6 items, 3 of them are related to anesthesia and the others related to surgical procedure. The scoring ranges from 6 to 30 in total. The value of \>11 is considered as high-anxiety level.

Trait Anxiety assessed with Spielberger Trait Anxiety Inventory (STAI-T)

时间窗: one week before the procedure

There are total 40 questions in d STAI-T (20). For each question the patients score ranged from 1 (almost never) to 4 (almost always) points. The sum of the scores range from 20-80. The score between 36 to 41 refer the mean anxiety level, and the values above 41 classified as high level of anxiety.

次要结局

  • Pain severity change(1st, 3rd and 7th day after surgery)
  • Analgesic consumption per day(1st, 3rd and 7th day after surgery)

研究者

发起方
T.C. ORDU ÜNİVERSİTESİ
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Damla Torul

Research Asistant

T.C. ORDU ÜNİVERSİTESİ

研究点 (1)

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