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临床试验/NCT06243705
NCT06243705已完成不适用

Assessing the Effectiveness of Robot-pets in Reducing Dental Anxiety in Children: A Randomized Controlled Clinical Trial

Aydin Adnan Menderes University2 个研究点 分布在 2 个国家目标入组 72 人开始时间: 2023年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
2
主要终点
Assesment of Heart Rate and Oxygen Saturations

研究概览

简要总结

Dental anxiety is a psychological condition marked by fear and worry about potential negative experiences during dental treatment, often accompanied by a feeling of loss of control. Dental anxiety is common in children and adolescents and is associated with a lower quality of life related to oral health. Furthermore, it correlates with an increased incidence of untreated caries. Using behavioral management techniques can help children cope with dental anxiety, making it easier for them to undergo treatment in a positive and healthy way.

Primarily aim of this study is to evaluate the effectiveness of using a robot-pet to reduce dental anxiety in children. Additionally, the research aims to compare the efficacy of this technique with the audiovisual distraction technique and to evaluate children's perceptions regarding the use of a robot-pet.

详细描述

Dental anxiety is a universal phenomenon that affects people of all ages in different countries. This condition negatively affects the quality of life related to oral health in children and adults. Dental anxiety has a negative impact on children's oral and dental health. Studies have reported that children with dental anxiety have poorer oral hygiene and untreated dental caries.

Basic behavior management strategies are commonly employed in dental offices to shape a child's behavior, teach coping skills, instill positive attitudes, build trust, and enable effective and efficient treatment. These strategies include traditional techniques such as tell-show-do and voice control, as well as contemporary techniques such as cognitive behavioral therapy and audio-visual distraction.

Tell-Show-Do (TSD) is a well-known basic behavioral technique. This technique involves verbally explaining dental procedures or instruments to the child using developmentally appropriate language. The visual, auditory, olfactory, and tactile aspects of the procedure are then demonstrated to the patient in a carefully defined, non-threatening environment. Finally, the procedure is performed without deviating from the initial explanation and demonstration.

Audiovisual distraction is a technique that combines visual and auditory components. It involves a spectacle system that consists of a head-mounted display and in-ear headphones. The aim is to reduce visual and auditory interference from the sounds and images of the dental working environment. This technique is intended to distract children during dental treatment by immersing them in a two- or three-dimensional world. According to some suggestions, this application may be more effective than traditional distraction methods due to its technological and engaging nature.

Animal-assisted therapy is a targeted intervention that uses a trained animal in a healthcare setting to improve patient interactions or reduce anxiety, pain, or distress. Appointments for animal-assisted therapy are scheduled for a specific time and duration, and the animals used have undergone temperament testing, rigorous training, and certification. According to a report, animals used during dental visits can help patients overcome communication barriers and reduce stress related to treatment by establishing a safe and relaxing relationship with the dentist. Animal-assisted therapies can increase children's compliance in the clinic and distract their attention. However, due to clinical hygiene conditions, it may pose risks to both trained animals and dental personnel. If necessary, precautions are taken, it can be applied. To eliminate the mentioned risks and difficulties, robots in cat/dog form can be used to apply this useful technique. In this context, it is important to keep up with developments in behavior management and assess their suitability for clinical practice. It is believed that using a robot-pet can enhance children's cooperation during dental procedures. This study provides guidance for clinicians on an alternative method of behavior management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • : Children are eligible for inclusion if;
  • They are 6 to 10 years old
  • They have no previous dental treatment
  • They have at least one of the permanent first molars is fully erupted

排除标准

  • Children will be excluded from the study if;
  • They do not have a parental agreement to participate
  • They need emergency care, such as dental trauma or pain
  • They have incomplete eruption of all permanent first molars
  • They have special health care needs, intellectual disabilities or autism spectrum disorders
  • They have phobia of animals such as cats or dogs
  • If their Frankl Behaviour Rating Score is 1 (Strongly Negative)

结局指标

主要结局

Assesment of Heart Rate and Oxygen Saturations

时间窗: Before Treatment, During Fissure Sealant Application-Surface Cleaning Phase, During Fissure Sealant Application-Isolation Phase, During Fissure Sealant Application-Washing Phase, Immediately After Treatment

Evaluation of the physiological parameters heart rate and oxygen saturation shows the interaction between the autonomic nervous system and dental anxiety. These values provide information about the children's cardiovascular and respiratory responses during treatment.

Assesment of Dental Anxiety- Children's Fear Survey Schedule-Dental Subscale

时间窗: Before Treatment, Immediately After Treatment

The Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) is a specific tool designed to assess dental anxiety and fear in children. 1. Dentists 2. Doctors 3. Injections 4. Having somebody examine your mouth 5. Having to open your mouth 6. Having a stranger touch you 7. Having somebody look at you 8. The dentist drilling. 9. The sight of the dentist drilling 10. The noise of the dentist drilling 11. Having somebody put instruments in your mouth 12. Choking 13. Having to go to the hospital 14. People in white uniforms 15. Having the dentist clean your teeth Each item was scored between 1-5 according to the answer given (Scoring is as follows: 1= Not afraid at all, 2= A little afraid, 3= Moderately afraid, 4= Quite afraid, 5= Very afraid).

Assesment Of Behaviour- Modified Houpt Behaviour Rating Scale

时间窗: During Fissure Sealant Application-Surface Cleaning Phase, During Fissure Sealant Application-Isolation Phase, During Fissure Sealant Application-Washing Phase

This is a three-stage scale designed to assess the child's compliance and cooperative behaviour during dental treatment. It is a scale in which the child is assessed by the dental practitioner on three different parameters relating to movement, crying and overall behaviour and scored from 1 to 4 according to their behaviour. Movement: 1=no movement 2= Controllable movement 3=Continuous movement 4=Violent movement Crying: 1= No crying 2= Intermittent mild crying 3= Continuous persistent crying 4= Hysterical crying Overall Behaviour: 1= Excellent, treatment completed 2= air, treatment interrupted, but eventually all completed 3= oor, treatment interrupted, only partial treatment completed 4= Aborted, no treatment rendered

Assesment of Dental Anxiety- Facial Image Scale

时间窗: Before Treatment, Immediately After Treatment

The Facial Image Scale consists of a series of five faces ranging from very happy to very unhappy. Children were asked to point to which face they felt most like at that moment. The scale is scored by rating the face with the most positive affect as 1(Very Happy) and the face with the most negative affect as 5(Very Unhappy).

Assesment of Behaviour- Frankl Behaviour Rating Scale

时间窗: Before Treatment, Immediately After Treatment

Dental professionals uses this scale to systematically assess and record information about child's behaviour in the dental clinic environment.The behaviour is rated from 1 to 4 (strongly negative (1), negative (2), positive (3), strongly positive (4))

次要结局

  • Evaluate the Child's Perspectives on the Use of Virtual Reality Glasses(Immediately After Treatment)
  • Assesment of Parents' Perspectives on the use Virtual Reality Glasses(Immediately After Treatment)
  • Evaluate the Child's Perspectives on the Use of Robot-Pet(Immediately After Treatment)
  • Assesment of Parents' Perspectives on the Use of Robot-Pet(Immediately After Treatment)

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melis AKYILDIZ

Post Doctoral Investigator

Aydin Adnan Menderes University

研究点 (2)

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