The Influence of Communication After Placement of Orthodontic Fixed Appliances on Pain, Anxiety and Oral Health Quality of Life Among Malaysian Population
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- change in pain (VAS)
研究概览
简要总结
Assessing the influence of a telephone call or Whatsapp instant text message post bond up of fixed appliances on Pain Visual Analogue Scores, State-Trait Anxiety and Oral Health Quality of Life
详细描述
Methodology
Sample 250 new orthodontic patients that meet the research criteria, will be randomly divided into 3 groups (Group 1: Phone call, Group 2: WhatsApp message, Group 3: Control).
Intervention During the bond up appointment, all participants will receive the same advice on pain management. The control group (Group 3) will receive no post bond up intervention whereas the remaining two groups will either receive a single instant text message via WhatsApp (Group 2) or a telephone call (Group 1) 4-7 hours after bond up to provide pain advice, motivation and reassurance. No further message or phone call will be carried out unless the phone call group is unable to be contacted within the 4-7 hour time frame. In this instance, a second phone call will be attempted within 24 hours. The timing of the intervention is based on studies which suggest that pain starts approximately after 4 hours and peaks at 24 hours.
Questionnaires
During the duration of the study, all patients will be required to complete three separate online questionnaires at various time points over a 7-day period. The questionnaires include:
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •New patients requiring fixed preadjusted appliances in both arches
- •Age ≥ 16 years old
- •Patients of Mongoloid ethnicity
- •Patients with access to a cellular phone with Whatsapp instant messaging app
- •Patients with access to internet services and email account for questionnaire completion
- •Patients with partial bond up e.g delayed bond up of lower incisors or upper laterals
排除标准
- •History of reported chronic use of analgesic medication
- •History of chronic pain related pathology or disease
- •History of previous fixed orthodontic intervention
- •Patients that have recently had teeth extracted less than 2 weeks prior to bond up
- •Patients requiring bond of both arches on separate days
- •Syndromic patients
结局指标
主要结局
change in pain (VAS)
时间窗: every day for 1 week post bond up
measure daily change in pain post bonding of fixed appliances using a 10mm pain visual analogue scale. 0mm = no pain and 100mm = worst pain imaginable
次要结局
- Change in Anxiety (STAI)(everyday for 1 week post bond up. It consists of 40 statements which require the participant to rate using a 4 point likert scale.Total scores can range between 40 to 160. Higher scores indicate increased anxiety .)
研究者
Dr Yasmin Kamarudin
Principle investigator
University of Malaya