Efficacy of laser acupuncture for dental anxiety and its association with salivary alpha amylase levels in children- A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Anxiety levels measured pre and post laser acupuncture objectively (MCDAS) & its association with salivary alpha amylase levels.
研究概览
简要总结
Dental fear and anxiety can result in avoidance of treatment, leading to a significantly stressful experience for the child. Dental anxiety assessment can be done by various methods, like objective (blood pressure, heart rate using pulse oximeter, salivary biomarkers) and subjective strategies (anxiety rating scales). They are the Venham Picture Test, Facial Image Scale, Modified Child Dental Anxiety Scale, Children Fear Survey Schedule-Dental Subscale, Hamilton Anxiety Rating Scale. Dental anxiety can be managed by various methods including relaxation, acupressure, distraction, behavioural techniques, acupuncture and laser acupuncture. Laser acupuncture is a non-invasive treatment that uses a low intensity laser beam to stimulate acupuncture points instead of a needle. Various anti-anxiety points which are tried & tested are Shen men point, relaxation point, extra-one point, union valley point, shoulder well point, great surge point, Nei guan point. This study was planned to evaluate the efficacy of laser acupuncture for dental anxiety management during various treatment procedures in children of age 6 to 12 yrs. Children from OPD in the Department of Paediatric and Preventive Dentistry will be screened. Based on inclusion and exclusion criteria, 42 children aged 6-12 years will be recruited into the study. The children will be allocated into 2 groups- Group-1: Sham laser acupuncture & Group-2: laser acupuncture. Pre & post operatively heart rate will be assessed with pulse oximeter, dental anxiety will be assessed using modified child dental anxiety scale (8-12 yrs), facial image scale (6-8 yrs). With patient in upright position, Salivary samples are collected using drooling method and subjected to ELISA for estimation of salivary alpha amylase levels pre & post operatively. Acupoints will be located and marked followed by laser stimulation of acupoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 14.00 Year(s)(—)
- 性别
- All
入选标准
- •Children with Frankl’s definitely negative and negative behavior.
- •Children with Facial image anxiety score 4-5 and MCDAS score more than 19 included in this study.
排除标准
- •Children with history of systemic diseases or mental disabilities.
- •Children with history of under medication in last months which effects the salivary gland function.
- •Children with special care need will be excluded.
结局指标
主要结局
Anxiety levels measured pre and post laser acupuncture objectively (MCDAS) & its association with salivary alpha amylase levels.
时间窗: Baseline and 2 min after laser acupuncture
2.Subjective Axiety levels measurement pre and post laser acupuncture using anxiety rating scales.
时间窗: Baseline and 2 min after laser acupuncture
次要结局
- Level of cooperation for completion of treatment(Baseline & 2 min after laser acupuncture)
研究者
Dr Ramisetty Mounika
Vishnu Dental College
