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临床试验/CTRI/2025/06/089693
CTRI/2025/06/089693尚未招募2 期

Effect of aromatherapy and music therapy on anxiety reduction in pediatric dental patients for treatment under local anesthesia: A randomized controlled study

S Amulya1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年7月30日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
Pulse rate

研究概览

简要总结

Dental anxiety and pain are significant challenges in pediatric dentistry, often leading to non-cooperation during dental procedures and long term dental avoidance. Aromatherapy and Music therapy are non-invasive and patient friendly distraction techniques.

Aromatherapy uses essential oils like lavender which have been proven to reduce stress and anxiety by stimulating the olfactory system. Marconi’s union’s weightless series is chosen for this study as it is considered to be one of the world’s most relaxing songs. Music uses auditory stimulation to promote relaxation by stimulating dopamine production, decreasing heart rate and breathing pattern thus mimics state of relaxation and reduce physical markers of anxiety. AIM: The study aims to assess the effect of aromatherapy and music therapy on anxiety reduction in pediatric dental patients for treatment under local anesthesia.

OBJECTIVES OF THE STUDY:

1)To evaluate the effectiveness of aromatherapy on anxiety reduction in pediatric dental patients for treatment under local anesthesia.

2)To evaluate the effective of listening to Marconi Union’s weightless (Music therapy) on anxiety reduction in pediatric dental patients for treatment under local anesthesia.

3)To compare the efficacy of aromatherapy and music therapy on anxiety reduction in pediatric dental patients for treatment under local anesthesia.

Pulse rate and oxygen saturation will be recorded using portable pulse oximeter (pre-intervention) before and (post-intervention) after Local anesthesia. Anxiety levels will be assessed using venham’s anxiety scale and Facial image scale (pre-intervention) before and (post-intervention) after local anesthesia.

Group-1: Control Group Children will not be subjected to either aromatherapy or music therapy.

Group-2:Aromatherapy Group Lavender essential oil will be diffused in the treatment room using a ceramic diffuser. 4 drops of aroma oil will be poured on upper plate of ceramic diffuser and candle will be lit below the plate to allow the aroma to disperse throughout the room. Local anesthesia will be administered for the relevant dental procedure to be done.

Group-3:Music therapy Group Patient will be made to listen to Marconi Union’s weightless series with wireless headphones before the procedure begins. Local anesthesia will be administered for the relevant dental procedure to be done.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
6.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • 1.Children aged between 6 to 9 years requiring dental treatment.
  • 2.Children who were rated +ve on the Frankl behavior scale.
  • 3.Children with sufficient cognitive skills to complete the self-report scale.

排除标准

  • 1.Children whose parents refused to participate in this study.
  • 3.Children with any other respiratory diseases.
  • 4.Children under any medications.
  • 5.Children with acoustic problems.
  • 6.Children who are allergic to lavender essential oils that will be used in this study.
  • 7.Children who are allergic to local anesthesia.

结局指标

主要结局

Pulse rate

时间窗: At Base line and 1 minute after administration of local anesthesia.

Oxygen saturation levels

时间窗: At Base line and 1 minute after administration of local anesthesia.

Anxiety levels

时间窗: At Base line and 1 minute after administration of local anesthesia.

次要结局

未报告次要终点

研究者

发起方
S Amulya
申办方类型
Other [nil]

研究点 (1)

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