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临床试验/NCT07542665
NCT07542665招募中不适用

Comparative Evaluation of the Effects of Aromatherapy and Music Therapy on Anxiety in Children Undergoing Oral Radiological Examination for the First Time

Nigde Omer Halisdemir University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Anxiety level assessed by Facial Image Scale (FIS)

研究概览

简要总结

This study aims to evaluate and compare the effects of aromatherapy and music therapy on anxiety levels in children undergoing intraoral radiographic examination for the first time. Dental anxiety is a common problem in pediatric patients and can negatively impact cooperation and treatment outcomes.

Children included in the study will be randomly assigned to four groups: aromatherapy and music group, aromatherapy group, music therapy group, or control group. In the aromatherapy group, children will be exposed to a selected essential oil (lavender oil) before the radiographic procedure, while in the music therapy group, children will listen to calming music through a speaker. The group receiving both aromatherapy and music therapy will listen to music while being exposed to the essential oil. The control group will receive standard care without any additional intervention.

Anxiety levels will be assessed before and after the radiographic procedure using the Facial Imaging Scale (FIS). Simultaneously, pulse rate will be measured before and after the procedure using a finger pulse oximeter. The primary aim is to determine whether aromatherapy, music therapy, or a combination of both is more effective in reducing anxiety compared to the control group.

The findings of this study are expected to contribute to the development of simple, non-invasive, and cost-effective methods to improve the comfort and cooperation of pediatric patients during dental radiographic procedures.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Participants, care providers, and outcome assessors will be blinded to group allocation. Group assignments will be concealed throughout the study to minimize bias.

入排标准

性别
All
接受健康志愿者

入选标准

  • Children requiring panoramic radiography for dental examination
  • No previous history of dental radiographic procedures
  • Ability to understand and cooperate with the procedure
  • Provision of written informed consent by parents or legal guardians

排除标准

  • Presence of hearing or olfactory impairment
  • Use of medications that may affect anxiety levels or heart rate
  • Presence of systemic or neurological disorders
  • Inability to cooperate with the study procedures
  • Refusal of the child or parent/guardian to participate

研究组 & 干预措施

Control Group (CG)

Other

干预措施: Routine Care (Other)

Music Therapy + Aromatherapy (MAG)

Experimental

干预措施: Music Therapy (Behavioral)

Music Therapy + Aromatherapy (MAG)

Experimental

干预措施: Aromatherapy (Behavioral)

Music Therapy (MG)

Experimental

干预措施: Music Therapy (Behavioral)

Aromatherapy (AG)

Experimental

干预措施: Aromatherapy (Behavioral)

结局指标

主要结局

Anxiety level assessed by Facial Image Scale (FIS)

时间窗: Immediately before and immediately after panoramic radiography

Children's anxiety levels were assessed using the Facial Image Scale (FIS), a validated tool for measuring dental anxiety in pediatric patients. It consists of a series of five pictures of faces (from 1 to 5), ranging from very happy to very unhappy. The scale is scored with a score of 1 for the face with the most positive emotion and a score of 5 for the face with the most negative emotion. Scores obtained before and after the radiographic procedure were compared.

次要结局

  • Heart rate(Immediately before and immediately after panoramic radiography)
  • Presence artifacts in panoramic radiographs(Immediately after panoramic radiography)

研究者

发起方
Nigde Omer Halisdemir University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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