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临床试验/NCT07336719
NCT07336719已完成不适用

The Effect of Showing Cartoons and Playing Music During Dental Treatment on Pain and Treatment Anxiety in Children: A Randomized Controlled Trial

Selcuk University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Child Identification Information Form

研究概览

简要总结

This study investigated the effect of showing cartoons or playing music during the procedure on the physiological parameters of pain and fear experienced by children aged 6-12 undergoing tooth extraction treatment.

详细描述

Pediatric patients are frequently exposed to medical procedures that can cause pain and anxiety. While pharmacological interventions may be used, distraction is a simple and effective technique that diverts children's attention away from distressing stimuli. Distraction is a non-pharmacological pain management technique widely used by healthcare professionals during procedures to reduce pain and distress. It is based on the assumption that by shifting the child's attention to something interesting, their ability to pay attention to painful stimuli is inhibited, thereby reducing pain, distress, and anxiety. However, there are no published studies examining the effect of watching cartoons, listening to music, and the tell-show-do approach during tooth extraction on the physiological parameters, pain, and anxiety of children aged 6-12 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Be between 6 and 12 years of age,
  • Have no systemic, neurological, or chronic diseases,
  • Agree to sit in the patient chair (according to the Frankl scale: 2, 3, or 4),
  • Have no mental or neurological problems,
  • Understand and speak Turkish,
  • Have an indication for tooth extraction
  • Willingness to participate in the study,
  • No visual or auditory impairments

排除标准

  • Being a foreign national,
  • Not wanting to participate in the study,
  • Not agreeing to sit in the patient chair (1 on the Frankl scale)

研究组 & 干预措施

Experimantal Group: Cartoon Group

Experimental

In this group of 20 children, cartoons were shown during the tooth extraction procedure. Before the procedure began, the child's vital signs (heart rate and blood oxygen level), pain level, and fear level were measured. The child watched their chosen cartoon during the procedure. Vital signs and pain level were measured again during the procedure. One minute after the procedure was completed, the child's vital signs, pain level, and fear level were measured again.

干预措施: Cartoon viewing app (Other)

Experimantal Group: Music Group

Experimental

In this group of 20 children, music was played during the tooth extraction procedure. Before the procedure began, the child's vital signs (heart rate and blood oxygen level), pain level, and fear level were measured. The music chosen by the child was played during the procedure. Vital signs and pain level were measured again during the procedure, and again 1 minute after the procedure was completed.

干预措施: Music intervention (Other)

Control Group

Other

The control group consisted of 20 children who underwent the routine procedure. One minute before the procedure, the child's vital signs (heart rate and blood oxygen level), pain level, and fear level were measured. Vital signs and pain level were measured again during the procedure. One minute after the procedure was completed, the child's vital signs, pain level, and fear level were measured again.

干预措施: control group (Other)

结局指标

主要结局

Child Identification Information Form

时间窗: Five minutes before the procedure

This form was created by researchers based on the literature to determine the identifying characteristics (age, gender, type and duration of treatment, etc.) of a child undergoing dental treatment.

Physiological Parameter Follow-up Form (Heart rate-min)

时间窗: Tooth extraction 1 minute ago

This is a form developed by researchers to assess the pulse and oxygen saturation of a child undergoing treatment.

Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)

时间窗: Tooth extraction 1 minute ago

This is a form developed by researchers to assess the pulse and oxygen saturation of a child undergoing treatment.

Wong Baker Facial Pain Rating Scale

时间窗: Tooth extraction 1 minute ago

The Wong Baker Facial Rating Scale is one of the scales used to assess pain. This scale consists of six facial expressions, rated from 0 to 10 according to the severity of the pain.

Child Fear Assessment Scale-Dental Subscale (CFSS-DS)

时间窗: Tooth extraction 1 minute ago

The CFSS-DS scale consists of 15 questions covering different aspects of dental treatment. It can be used with children aged 4-14 years. It is used to determine children's fear of tooth extraction.

次要结局

  • Physiological Parameter Follow-up Form (Heart rate-min(5th minute of the process)
  • Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)(1 minute after the procedure)
  • Wong Baker Facial Pain Rating Scale(1 minute after the procedure)
  • Physiological Parameter Follow-up Form (Heart rate-min)(1 minute after the procedure)
  • Child Fear Assessment Scale-Dental Subscale (CFSS-DS)(1 minute after the procedure)
  • Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)(5th minute of the process)
  • Wong Baker Facial Pain Rating Scale(5th minute of the process)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sibel Küçükoğlu

Prof.

Selcuk University

研究点 (1)

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