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临床试验/CTRI/2024/04/066071
CTRI/2024/04/066071尚未招募不适用

Comparative evaluation of effectiveness of a novel technique of dual sensory stimulation on dental anxiety and behaviour among pediatric patients- a randomized controlled trial.

Namrata Puri1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2024年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
138
试验地点
1
主要终点
To evaluate and compare the effectiveness of audio - visual distraction technique and visual- olfactory distraction technique in reducing anxiety among children undergoing a restorative procedure

研究概览

简要总结

Fear and anxiety toward the dentist and dental treatment are common problems faced by Paediatric dentist and therefore it is important to explore alternative methods to reduce them. Dental anxiety has been contemplated as an obstacle in rendering quality dental care. The successful management of these children depends on the ability of the dentist to guide the children through their dental experiences by selecting behavior managment strategies that will allay their fears and bring about a positive change. In a pediatric dental setup, the sight of needles, drilling sounds, bitter taste of anaesthesia, smells of cut dentin and eugenol along with the sensation of a high frequency of vibration, are usually anxiety provocation factors.It is necessary to overcome facets like anxiety-producing sounds , smell and taste  the pediatric patients. In order to do so, understanding patient’s perspective is an important  step, to formulate patient centric plan. In such situations, subjective evaluation by interviews and self-reporting on fear and anxiety scales and objective of pulse rates, pulse oximetry can greatly enhance the diagnosis and unable categorization of these children/ patients. In recent times, the attitude of parents as well as of dental professional with respect to traditional behavior management techniques such as immobilization in a papoose board is refurbishing. Parents   are getting more and more apprehensive about pharmacological methods for behaviour management of their children due to unwanted medical risks associated with it. As a result of that, clinicians around the world have developed non-aversive techniques. Therefore, finding effective strategies to reduce anxiety during dental visits is clinically important for promoting the oral health and well-being of children. aim of study is to evaluate and compare the effect of a novel technique of dual sensory stimulation audiovisual versus visual olfactory on dental anxiety and behaviour for pediatric patients aged 4-7years. The selection of cases will be done based on inclusion and exclusion criteria. The treatment protocol will be explained to all the patients and their guardians. The study will be conducted among 138 children in age group 4-7 years visiting Out Patient Department of Department of Pediatric and Preventive Dentistry, Manav Rachna Dental College, Faridabad.  Demographic data including age, sex and education will be noted.  Written informed consent will be taken from the guardians. ASSESSMENT OF PRE OPERATIVE ANXIETYThe child’s pulse rate and oxygen saturation will be recorded manually with the help of pulse oximeter. The child will then be questioned using CBCS (Chota Bheem Chutki Scale) and Venham’s  Picture Test EXAMINATION OF SUBJECTThe subjects were made to sit comfortably. Intra-oral examination was done wearingmouth mask and sterile latex gloves. The clinical intra oral examination of the subjects will be done and behavior of the child was assessed using Frankl’s behavior rating scale. Children displaying Frankl’s 2 and 3 level of behavior will be selected for the study.The 138 study participants will be randomized using Graph Pad Prism online software in three different groups (N=46). The children will be grouped in Group A, B and C according to the distraction method to be used.  Each group will have 46 children.  The selected participants will then be taken into the dental operatory room prepared for the child.

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 Blinded

入排标准

年龄范围
4.00 Year(s) 至 7.00 Year(s)(—)
性别
All

入选标准

  • Healthy children of age group 4-7 years First dental visit Children who are rated as Frankl +ve or Frankl –ve according to the Frankl Behaviour Rating Scale Patient with class I and class II caries extending 1.5 to 2 mm into the dentin that qualifies for restoration.

排除标准

  • Children with special healthcare needs.
  • Children with sensory disabilities.
  • Subjects experiencing dental pain.
  • History of chronic illness.
  • Known allergy to an essential oil (jasmine).

结局指标

主要结局

To evaluate and compare the effectiveness of audio - visual distraction technique and visual- olfactory distraction technique in reducing anxiety among children undergoing a restorative procedure

时间窗: anxiety levels will be assessed pre and post operatively | no follow ups

次要结局

  • to check the reduction in dental anxiety using audio visual & visual olfactory distraction technique by checking physiological parameters- pulse rate & anxiety levels using chota bheem chutki scale, veham picture test & frankle behaviour rating

研究者

发起方
Namrata Puri
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Namrata Puri

Manav Rachna Dental College

研究点 (1)

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