Effectiveness of Auricular Acupuncture in Reducing Dental Anxiety and Pain Perception During Orthodontic Extractions Among Adolescents - A Crossover Double-Blinded Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Dental fear
研究概览
简要总结
This prospective, randomised, double-blinded cross-over study aims to compare the effectiveness of auricular acupuncture (AA) with placebo sham acupuncture (PSA) in reducing dental anxiety, pain perception and physiological responses to stress and anxiety among adolescents during orthodontic extractions.
Adolescents aged between 10-19 years old who are undergoing orthodontic treatments requiring bilateral premolar extractions will be invited to complete a validated questionnaire to record their dental anxiety level, oral health knowledge, attitudes, practices, demographic and socio-economic factors. During orthodontic extractions, physiological responses including heart rate and oxygen saturation will be measured with a fingertip pulse oximeter throughout the process.
The participants will be allocated randomly to one of the two groups in the study.
Group 1-- auricular acupuncture in their first orthodontic extraction visit and placebo sham acupuncture in their second orthodontic extraction visit.
Group 2-placebo sham acupuncture in their first orthodontic extraction visit and auricular acupuncture their second orthodontic extraction visit.
Both acupuncture interventions will be carried out by a Hong Kong registered Chinese medical practitioner. The acupuncture needles are kept in place for 20 minutes to exert its effect before the dental extraction. Placebo sham acupuncture will not cause any harm, but the acupuncture points have no reported effect on stress relief.
The extraction of premolars will be performed by a Hong Kong registered dentist. Local anesthesia is injected to numb the respective site, then the premolar will be removed with forceps, followed by stopping the bleeding by biting firmly on gauze.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Both acupuncture interventions will be carried out by a Hong Kong licenced Chinese medical practitioner (CMP) with no involvement in data collection and assessment. A research assistant will be responsible for the randomisation and inform the CMP regarding the group allocation. The acupuncture needles are kept in place for 20 minutes before the dental treatment.
The extractions of premolars will be performed by a licenced general dental practitioner who is blinded towards the types of acupuncture received, so as the patient and their parents or caretakers.
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergoing orthodontic treatment and require bilateral extraction of premolars.
- •Have parental consent signed by their parent or guardian.
- •Medically fit with either ASA I or II status
- •Have not taken any medications, especially anxiolytics and antidepressants
- •The premolars to be extracted should be fully erupted and without any signs of ankylosis.
排除标准
- 未提供
结局指标
主要结局
Dental fear
时间窗: Baseline, immediately after the intervention. immediately after the surgery
Self-reported dental fear measured by Spielberger State Trait Anxiety Inventory score, Scores range from 20 to 80, with higher scores correlating with greater anxiety
次要结局
- Psychological changes(Baseline, perioperatively, immediately after the surgery)
- Pain perceived(Immediately after the intervention. immediately after the surgery)