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临床试验/NCT04892394
NCT04892394已完成不适用

Determining the Effect of Video Information on the Dental Anxiety Levels of the Endodontic Patients: A Randomized Clinical Trial

Aydin Adnan Menderes University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年3月12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
120
试验地点
2
主要终点
Electrodermal activity level comparison during endodontic treatment with two preoperative information types

研究概览

简要总结

This study compared the effect of the detailed video visual information and basic verbal information on patients' anxiety levels (using anxiety scales) before endodontic treatment and stress levels (using electrodermal activity method) during endodontic treatment.

详细描述

Patients (n=120) aged between 18-65 with single-rooted teeth with the single canal that diagnosed with asymptomatic irreversible pulpitis and/or pre-prosthetic root canal treatment were included in this study. Patients were randomly divided into two groups after completing anxiety scales and socio-demographic/dental habits form. Before the treatment, visual video information was given to the video group patients, while the control group patients were routinely informed verbally. The stress levels during the endodontic treatment process were recorded by placing a electrodermal activity measurement device on the wrists of the patients. Anxiety scales and feedback-satisfaction forms were administered to all patients after the treatment process.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 18 - 65 years of ages
  • Patients with healthy (ASA 1) and mild systemic disease (ASA 2) according to ASA classification
  • Patients with no mental disorders in their medical history
  • Patients who do not have a psychiatric disorder that they have started, and who do not use psychotherapeutic drugs.
  • Literate and not visually impaired patients
  • Patients presenting with single-rooted teeth with a single root canal diagnosed with asymptomatic irreversible pulpitis or single-rooted vital teeth with a single root canal requiring root canal treatment due to prosthetic reasons

排除标准

  • Patients who refuse to participate this study
  • Patients have existing pain caused by another tooth
  • Patients with dermatological disease in the medical histories
  • Medically compromised patients (with immunosuppressive/systemic diseases, patients on medications)
  • The presence of spontaneous pain, swelling, or fistula in the relevant tooth
  • Teeth whose working length cannot be reached due to calcification and step formation in the root canal
  • The presence of foreign material in the root canal that prevents entry (broken instrument, post)
  • The presence of advanced periodontal disease (probing depth > 4 mm) or root fracture in the relevant tooth
  • Patients using pain medication on the same day before treatment (within 24 hours)

结局指标

主要结局

Electrodermal activity level comparison during endodontic treatment with two preoperative information types

时间窗: During endodontic treatment process

At the beginning of the endodontic treatment, the GSR device was attached to the patient's preferred wrist, and the measuring tapes of the device were placed on the patient's proximal phalanges of the index and middle finger. One-visit endodontic treatment was divided into 7 steps (anesthesia, cavity preparation, rubber dam placement, determination of root canal length, root canal shaping, root canal filling, coronal restoration and finishing) and recorded. All data transmitted to the computer via a wireless connection by a software program were recorded at the end of the treatment.

Anxiety level comparison after endodontic treatment with two preoperative information types

时间窗: Immediately after treatment

Modified Dental Anxiety Scale (MDAS) was used to assess anxiety levels. The Modified Dental Anxiety Scale (MDAS) consisted of 5 questions ranging from 5 (no anxiety) to 25 (highest anxiety level). Every patient was asked to mark his or her perceived dental anxiety level on the line.

次要结局

  • Evaluation of the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics and dental treatment habits(Before Endodontic Treatment)

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hicran Dönmez Özkan

Assistant Professor

Aydin Adnan Menderes University

研究点 (2)

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