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临床试验/NCT05663619
NCT05663619已完成不适用

The Effect of Virtual Reality Distraction on Anxiety Level During Dental Treatment Among Anxious Pediatric Patients: A Randomized Clinical Trial

King Abdulaziz University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Venham Anxiety and Behavioral Rating Scale

研究概览

简要总结

Objective: This study evaluated the effect of Virtual Reality Distraction (VRD) on dental anxiety among anxious children undergoing prophylactic dental treatment by utilizing both subjective (Venham Anxiety and Behavioral Rating Scale (VABRS)) and objective (heart rate (HR) and salivary cortisol level (SCL)) measures. Method and Materials: This randomized controlled study included 36 6- to 14-year-old healthy and anxious children who needed prophylactic dental treatment and who had a history of previous dental treatment. The eligible children's anxiety level was evaluated using a modified version of Abeer Dental Anxiety Scale-Arabic version (M-ACDAS) and those who scored at least 14 or more out of 21 were included. Participants were randomly distributed to either the VRD or control group. In the VRD group, participants wore the VRD device during prophylactic dental treatment. In the control group, subjects received their treatment while watching a video cartoon on a regular screen. The participants were videotaped during the treatment and their HR was recorded at four time points. Also, a sample from each participant's saliva was collected twice, at the baseline and after the procedure.

详细描述

The aim of this study was to evaluate the effect of virtual reality distraction among 6- to 14-year-old anxious children undergoing prophylactic dental treatment by utilizing both subjective (Venham Anxiety and Behavioral Rating Scale (VABRS)) and objective (heart rate and salivary cortisol level) measures.

This two-arms parallel randomized controlled study was conducted at the Department of Pediatric Dentistry at King Abdulaziz University Dental Hospital (KAUDH) between January and May 2022, after obtaining the ethical approval from the Research Ethics Committee of the Faculty of Dentistry (341-11-21) at King Abdulaziz University. The study is reported according to the protocol established by the Consolidated Standards of Reporting Trials (CONSORT) statement (18).

The inclusion criteria were 6- to 14-year-old, healthy children with a history of previous dental treatment. The included subjects also had to have high dental anxiety (high score on a modified version of Abeer Children Dental Anxiety Scale (M-ACDAS)) . Children with visual or auditory deficits, a history of epilepsy, and/or anxiety disorder, and non-Arabic speaking children were excluded.

Records of pediatric patients on the dental treatment waiting list were reviewed and potentially eligible children were contacted via the phone. The aim of the study was introduced to the parents/guardians, and upon agreement to participate, an appointment was scheduled.

Abeer Children Dental Anxiety Scale (ACDAS), a cognitive dental anxiety scale, is the first Arabic validated cognitive dental anxiety scale developed to measure anxiety in children and adolescents. It consists of 19 self-reported questions arranged in a logical order to assess dental anxiety in children (19). In this study, the ACDAS was modified (M-ACDAS), and only seven of the 19 self-reported questions were included to avoid a lengthy questionnaire with the children (Figure 1). Each question can be scored 1, 2, or 3 by choosing between three faces with different expressions. The first face is a smily face and reflects the feeling of being relaxed, happy, and not scared, while the second face represents a neutral feeling; and the third face is a sad face and represents anxious and scared feeling. The children were asked to circle the face that best represented his/her response to the question. Therefore, the total values ranged from 7 to 21. The M-ACDAS was used at the beginning of the scheduled appointment in the waiting area to assess the pre-treatment anxiety level of the potentially eligible children. Those who scored 14 (66.7% of the maximum score) or more were considered anxious and were included in the study. Those who scored less than 14 in the M-ACDAS were excluded from the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 6- to 14-year-old.
  • With a history of previous dental treatment.
  • High dental anxiety (high score on a modified version of Abeer Children Dental Anxiety Scale (M-ACDAS)).

排除标准

  • Visual or auditory deficits.
  • History of epilepsy, and/or anxiety disorder.
  • Non-Arabic speaking children.

结局指标

主要结局

Venham Anxiety and Behavioral Rating Scale

时间窗: 1 day (during dental treatment procedure)

During the treatment, participants were videotaped using a high-resolution camera. Later, two trained and calibrated evaluators assessed the participant's anxiety using the Venham Anxiety and Behavioral Rating Scale independently. The scale consists of five defined behavioral categories ranging from zero to five. A higher score indicates a greater level of anxiety.

Change in Heart rate

时间窗: (1) as a baseline in the waiting area before dental treatment; (2) in the dental chair immediately before starting the procedure; (3) during prophylactic dental treatment procedure; (4) immediately after the procedure was completed

The HR was recorded using a pulse oximeter

Change in Salivary cortisol levels.

时间窗: (1) as a baseline in the waiting area before dental treatment; (2) immediately after the dental procedure was completed

Two saliva samples were collected from each participant: (1) as a baseline in the waiting area; (2) after the dental procedure was completed. Approximately two mL of saliva was collected using Salivettes®, and the samples were stored at -20oC until evaluation. To minimize the effects of the diurnal cortisol cycle, all study procedures and saliva sample collection were performed between 10:00 am and 2:00 pm. The cortisol levels were measured using the Cortisol Saliva Enzyme-Linked Immunosorbent Assay (ELISA) Assay Kit (ab 154996- cortisol ELISA kit, Abcam, UK) following the manufacturer's instructions.

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

Osama M Felemban

Associate Professor in Pediatric Dentistry

King Abdulaziz University

研究点 (2)

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