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临床试验/NCT03739346
NCT03739346Unknown不适用

Efficacy of Hypnosis Compared With Tell/Show/do Technique in Anxiety/Pain Reduction in Children During Pulpotomies

Alejandra Ramírez Carrasco0 个研究点目标入组 60 人开始时间: 2018年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
Face, Legs, Activity, Cry and Consolability Scale

研究概览

简要总结

Anxiety and pain are emotions that the child often experiences in the dental office, generating the appearance of negative, uncooperative and even disruptive behaviors during the treatment; these make it difficult for dental care and the possibility of establishing a relationship of trust between the pediatric dentist and the patient. The pediatric dentist must promote a positive attitude of the child throughout the dental treatment, keep the child calm and avoid feeling pain is essential at each appointment.

When carrying out dental treatments that are more invasive or painful for the patient, such as pulpotomies, it is difficult to distinguish and separate anxiety from pain.

In this project, anxiety/pain will be managed as a whole, to assess it with the same scale, and to correlate the scores obtained with the variations in skin conductance and heart rate, before, during and after perform pulpotomies in children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 7 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Without previous dental experiences, patients with clinical and radiographic indication of pulpotomy in at least one temporary inferior molar, clinically healthy patients, patients whose parents accept entry into the study and who sign the informed consent.

排除标准

  • •Patients who have received hypnosis before.

研究组 & 干预措施

Control

Experimental

Tell, show, do technique

干预措施: Tell, show, do technique (Behavioral)

Intervention

Experimental

Hypnosis.

干预措施: Hypnosis (Behavioral)

结局指标

主要结局

Face, Legs, Activity, Cry and Consolability Scale

时间窗: Change from score in baseline at score during pulpotomies and after pulpotomies, through study completation average 3 months.

A measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. Each category is scored on the 0-2 scale which results in a total score of 0-10. 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain

次要结局

未报告次要终点

研究者

发起方
Alejandra Ramírez Carrasco
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alejandra Ramírez Carrasco

Principal Investigator

Universidad Autonoma de San Luis Potosí

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