Integrating Multi-Modal Education to Improve Patient Compliance, Knowledge Retention, and Anxiety Reduction After Dental Extractions: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Knowledge Retention of Post-Extraction Care
研究概览
简要总结
The goal of this clinical trial is to learn whether using a new Post-Dental Extraction Care Kit (PDEC-kit) can help patients better understand and follow their post-extraction instructions, and whether it can also reduce dental anxiety, compared with verbal instructions alone. The study is being conducted among adult patients (18 years and older) undergoing routine tooth extractions under local anaesthesia at a university oral surgery clinic.
The main questions this study aims to answer are:
Does the PDEC-kit improve patients' knowledge retention about post-extraction care?
Does the PDEC-kit improve patient compliance with important post-extraction behaviours (e.g., medication use, diet, activity restrictions)?
Does the PDEC-kit reduce patient anxiety compared with standard verbal instructions?
Researchers will compare two groups of patients:
One group will receive the usual standardised verbal instructions.
The other group will receive the same verbal instructions plus the PDEC-kit.
Participants in the PDEC-kit group will:
Watch a short educational video on post-extraction care.
Review illustrated flashcards showing key "dos and don'ts."
Observe a live demonstration using a dental model to learn how to place and bite on gauze correctly.
Take home a bilingual brochure (English and Bahasa Melayu), also available via QR code.
All participants will be asked to answer short questionnaires about their knowledge, behaviour, and dental anxiety at three time points: before the extraction, immediately after receiving instructions, and one week later.
详细描述
Scientific Rationale
Tooth extraction is one of the most frequently performed dental procedures. Despite its routine nature, poor comprehension of post-operative instructions may lead to complications such as alveolar osteitis, infection, or delayed wound healing. Evidence from health communication research shows that patients retain only a small proportion of verbal-only instructions, particularly in settings of heightened anxiety. Multimedia learning theory (Mayer, 2021) suggests that simultaneous delivery of verbal, visual, and kinesthetic information enhances encoding and recall.
Building on this theory, the Post-Dental Extraction Care Kit (PDEC-kit) was developed. It integrates audiovisual, pictorial, and demonstration-based teaching into a structured package that supplements standard verbal guidance. The central hypothesis is that the PDEC-kit improves knowledge retention, compliance, and anxiety outcomes compared to verbal instructions alone.
Study Design Overview
This is a prospective, single-centre, two-arm, parallel-group randomized controlled trial. Participants are assigned to intervention or control groups in a 1:1 ratio. Allocation concealment was ensured using block randomisation with opaque, sequentially numbered envelopes. Operators performing extractions were blinded to allocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
盲法说明
Care providers performing the dental extractions were blinded to group allocation. Randomization occurred only after the extraction was completed, and the operating clinician was not involved in delivering post-operative instructions. Participants and the investigator providing instructions were not masked due to the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years or older
- •Scheduled for routine, non-surgical extraction of one or two adjacent permanent teeth
- •Able to read and understand either English or Bahasa Melayu
- •=Classified as American Society of Anesthesiologists (ASA) physical status I or II
- •Provide written informed consent
排除标准
- •Previous participation in this study
- •ASA physical status III or higher
- •History of diagnosed anxiety disorders, depression, or learning disabilities
- •Requirement for surgical, complex, or multiple extractions
- •Procedures expected to be difficult or requiring assistance from a supervising specialist
- •Inability to understand or follow study instructions
研究组 & 干预措施
Standardised Verbal Instructions
Participants receive the standardised verbal post-extraction care instructions delivered by a trained investigator using a calibrated script. No additional educational materials are provided.
干预措施: Standardised Verbal Instructions (Behavioral)
Intervention - Verbal Instructions + PDEC-kit
Participants receive the same standardised verbal post-extraction instructions as the control group, supplemented with the Post-Dental Extraction Care Kit (PDEC-kit). The kit includes:
A 2-minute educational video
Illustrated flashcards of dos and don'ts
Live demonstration of gauze placement using a dental model
Bilingual brochure (English and Bahasa Melayu), with QR code for digital access
干预措施: Verbal Instructions + PDEC-kit (Behavioral)
结局指标
主要结局
Knowledge Retention of Post-Extraction Care
时间窗: Baseline (pre-extraction, T0), immediately after instruction (T1), and one-week post-operatively (T2).
Knowledge assessed using a structured four-item post-extraction care quiz (binary scoring, correct/incorrect). Higher scores indicate better knowledge retention.
次要结局
- Patient Compliance with Post-Operative Instructions(One-week post-operatively (T2).)
- Dental Anxiety (IDAF-4C+)(Baseline (T0), immediately after instruction (T1), and one-week post-operatively (T2).)
研究者
Tan Su Keng
Associate Prof. Dr.
Universiti Teknologi Malaysia