Effectiveness of Aromatherapy, Audiovisual Distraction and Vibration in management of dental anxiety in children aged 6-12 years: Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To assess subjects anxiety by RMS pictorial scale
研究概览
简要总结
The study will be carried out on children aged 6-12 years who will be reporting to the Department of Pediatric and Preventive dentistry, College of Dental Sciences, Amargadh, Bhavnagar, Gujarat to undergo dental treatment procedures which requires extraction requiring local anaesthesia (infiltration). after diagnosis and treatment planning, Written informed consent will be taken before starting the study.
A total of 150 children will be taken for the study which will be divided in to 3 different groups.
50 children will be allocate to each group which will be divided in to:
Group A : Tender Love Care (control group).
Group B : Aromatherapy in combination with Audio-visual (experimental group 1 )
Group C: Aromatherapy in combination with Vibration (experimental group 2 )
The lavender essential oil will be used to make the room aromatic before the treatment starts.
An electric aroma diffuser((model: psi-eard-miniroundldrwt, by Pure source india) will be used to diffuse essential oil sufficient enough to make the treatment room aromatic and for the audiovisual aid, cartoon video of their own choice will be played in front of child. Whenever the video is being played aroma will be diffused in the room.
In the second group, aroma and vibrating mat combination will there, vibrating mat(massager mat by Siarth) will be placed on the dental chair and child will seat on it during entire treatment time.
In the control group TLC approach will be use during LA administration (infiltration). it is associate with provision care, attention and affection for children.
This study is designed as a single blind (participants), randomized controlled trial with two parallel groups. Sample will be randomly allocated to the study groups by block randomization by pressure sensitive paper envelop for equal distribution of sample size in study group.
In this study physiological parameters will be assessed by using pulse oximeter . Pulse rate will be measured before and after treatment by using pulse oximeter((by DR VAKU). Children’s dental anxiety will be record by using Raghavendra, Madhuri, Sujata Pictorial Scale (RMS Pictorial Scale) before and after the dental treatment.
In all groups 2% of lignocaine with 1:80,000 adrenaline [Stim Lidayn] and 30 gauge needle (BD microlane ) will be use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy children without any systemic diseases.
- •2.Children of both sexes 3.Children aged between 6-12 years.
- •4.Children who require local anaesthesia (infiltration) for extraction.
排除标准
- •1.Children whose parents refused to participate in this study.
- •2.Children with any respiratory tract illnesses and common cold.
- •3.Children with visual and hearing impairments.
结局指标
主要结局
To assess subjects anxiety by RMS pictorial scale
时间窗: To assess subjects anxiety before the procedure as well as after the procedure
次要结局
- Reduction in dental anxiety(variation of pulse measured using pulse oximeter before and after extraction)
研究者
Dr Dhruvi Godhani
College of Dental Sciences,Amargadh,Bhavnagar,Gujrat