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临床试验/NCT07121608
NCT07121608已完成不适用

Exploring Dental Anxiety in Patients With Special Needs: A Randomised Cross-over Study of I-MDAS and Malay Version of MDAS

University of Malaya2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年3月14日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Agreement Between I-MDAS and M-MDAS in Measuring Dental Anxiety

研究概览

简要总结

This study aims to better understand and improve how dental anxiety is measured in patients with special needs (PSN) who visit the Special Care Dentistry (SCD) Clinic at Universiti Malaya (UM). Researchers want to find out:

Whether there is a difference in anxiety scores when using two versions of a dental anxiety questionnaire - the Inclusive Modified Dental Anxiety Scale (I-MDAS) and the Malay Modified Dental Anxiety Scale (M-MDAS).

Which version PSN prefer or find easier to use. What factors may cause higher dental anxiety in these patients. What factors are linked to more severe levels of dental anxiety.

Participants in this study will be randomly assigned to one of two groups. Each group will try out two different versions of a dental anxiety questionnaire - the written Malay Modified Dental Anxiety Scale (M-MDAS) and the Inclusive Modified Dental Anxiety Scale (I-MDAS), which includes video and narration.

First, participants will fill out a short questionnaire about their background, such as age, gender, education, medical history, and dental experiences.

Then, depending on their group, they will complete either the M-MDAS or the I-MDAS first.

After a one-week break (called a "washout period"), they will complete the other version of the questionnaire.

This allows researchers to compare both tools fairly and see which one is more effective and preferred by patients with special needs.

详细描述

This study is designed to improve how dental anxiety is measured in patients with special needs (PSN) who receive care at the Special Care Dentistry (SCD) Clinic at Universiti Malaya (UM). Dental anxiety can make it harder for patients to visit the dentist, especially those with disabilities or complex medical conditions. To support better care, researchers want to understand which assessment method works best for this group.

The study focuses on two versions of a dental anxiety questionnaire:

I-MDAS (Inclusive Modified Dental Anxiety Scale) - a video-based tool with narration and subtitles to make it more accessible.

M-MDAS (Malay Modified Dental Anxiety Scale) - a standard written version in the Malay language.

The study will explore:

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years and above
  • New and existing patients attending SCD clinic at Faculty of Dentistry, Universiti Malaya for elective dental treatment
  • Literate and able to understand the Malay language
  • Frankl behavioural rating scale of score 3 and 4

排除标准

  • Patients who require other urgent dental treatments
  • Severe or complex learning or ID
  • Frankl behavioural rating scale of score 1 and 2

结局指标

主要结局

Agreement Between I-MDAS and M-MDAS in Measuring Dental Anxiety

时间窗: Within 2 weeks of enrolment (completion of both I-MDAS and M-MDAS with 1-week washout period)

This outcome measures the level of agreement between the Inclusive Modified Dental Anxiety Scale (I-MDAS) and the Malay Modified Dental Anxiety Scale (M-MDAS) in assessing dental anxiety among patients with special needs (PSN). Agreement will be evaluated using statistical methods such as the intraclass correlation coefficient (ICC), Bland-Altman plot, and paired comparisons of total scores from both tools.

次要结局

  • Acceptability of I-MDAS Compared to M-MDAS(Immediately after completion of both anxiety scales (within 2 weeks of enrolment))
  • Factors Associated With Severity of Dental Anxiety (I-MDAS Scores)(At baseline (upon initial assessment during first visit))
  • Factors Associated With Presence of Dental Anxiety (I-MDAS)(At baseline (upon initial assessment during first visit))

研究者

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

Aisyah Ahmad Fisal

Dental Lecturer (Special Care Dentistry)

University of Malaya

研究点 (2)

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