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临床试验/NCT07371442
NCT07371442Enrolling By Invitation不适用

Effectiveness of Audiovisual Distraction and Acuapoint Stimulation on Anxiety and Pain Perception During Tooth Extraction in Children: A Randomized Controlled Clinical Study.

Mansoura University1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2025年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
69
试验地点
1
主要终点
Anxiety

研究概览

简要总结

The aim of this study is to evaluate the effectiveness of audiovisual distraction and acuapoint stimulation on anxiety and pain perception during tooth extraction 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, Investigator)

入排标准

年龄范围
5 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 1- Children with behavior rating score 2,3 according to Frankl's behavior rating scale.
  • 2- Children aged 5-8 years requiring primary tooth extraction. 3- Healthy children free of systemic diseases

排除标准

  • 1- Children with special health care needs.

研究组 & 干预措施

dental story

Experimental

A dental video story will be presented to patient using an iPad device connected to a noise cancellation headphone.

干预措施: Audiovisual (Device)

Aculief

Experimental

Aculief acupressure device will be placed on the LI4 Point which is located on the hand between the thumb and index finger, also described as the depression where the index finger and thumb bone go apart. The LI4 point will be identified in each patient by asking the patient to adduct the thumb and index finger. The duration will be 5 minutes before LA administration. to patients

干预措施: Acualief (Device)

TSD

Experimental

This group will be treated using Tell-show-do technique

干预措施: TELL SHOW DO (Behavioral)

结局指标

主要结局

Anxiety

时间窗: Will be measured 5 minutes before LA , immediately before extraction and immediately after extraction The total VPT score was obtained by summing the values across all eight panels, with higher scores indicating greater levels of anxiety (range: 0-8).

Anxiety will be measured by A) Pulse oximeter: Pulse oximeter was used to observe the physiological functions like heart rate and SpO₂. B) Venham's picture test: the child was presented with eight different cards. Each card held two pictures-a representation of the child expressing anxiety along with another representation of the same child in a relaxed mood. The child was asked to point out the picture in each pair that resembled how he/she was feeling. There was also an order in which the pictures had to be presented. Assigning the image depicting anxiety the score of 1 and the relaxed image the score of 0 helped in the coding process.

次要结局

  • Pain of the patient(Will be evaluated immediately after the local anesthesia and tooth extraction using Wong Baker FACES Pain rating scale, ranging from a no pain (score 0) to one showing severe pain (score 5))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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