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临床试验/CTRI/2025/01/079524
CTRI/2025/01/079524尚未招募不适用

Comparative evaluation of acupressure and aromatherapy on pain during Inferior Alveolar Nerve Block Injection in Children Aged 6-10 Years Old - An Experimental Study.

Acupressure healthcare system hyderabad1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
to evaluate the effect of acupressure and aromatherapy on pain of injection during IANB injection will be assessed.

研究概览

简要总结

Pain and anxiety during injecting LA is a common problem in pediatric dentistry. The continuous necessity to incorporate alternate techniques into clinical practice led to the introduction of a number of methods that have been suggested to reduce the pain induced by infiltration of local anesthesia agents. One such  pain control method is Acupressure, which has been shown to be effective for relieving a variety of pains in different populations. Another method is aromatherapy,  many claims have been made relating to the benefits of aromatherapy, most research has focused on its use to manage depression, anxiety, muscle tension, sleep disturbance, nausea, and pain. Considering the drawbacks of acupressure and the positive aspect of aromatherapy, this study proposes the comparison between the effect of acupressure and aromatherapy on pain of injection during IANB Block in children. Eligible children of 6-10 year old are randomized into three group :-

Group 1 - Control group

Group 2 - Acupressure group

Group 3 - Aromatherapy group

Pre-existing anxiety will be recorded using the Modified child dental anxiety scale.

Pain on injection: The discomfort of the injections will be recorded.

Subjectively- By Wong-Baker FACES Pain Rating Scale (FPS).

Objectively - By  Sound, Eye & Motor (SEM) scale  ratings will be performed from the video recordings by investigator 2.

Subjective and objective measurement will be recorded in customized case record proforma.

The data collected will be analyzed for further progress.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
6.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Healthy children in the age group 6-10-year.
  • 2.Children indicated for at least one clinical session of extraction requiring inferior alveolar nerve block.
  • Children with no acute pain.

排除标准

  • 1.Active infection at the site of injection 2.Children allergic to local anesthetic agents.
  • 3.Children with prior experience of local anesthetic injection.
  • 4.Children with pre-operative pain.

结局指标

主要结局

to evaluate the effect of acupressure and aromatherapy on pain of injection during IANB injection will be assessed.

时间窗: At the baseline

次要结局

  • To evaluate the acceptance of 2 different supplementary treatments (aromatherapy & acupressure) by the patient.(at tha baseline)

研究者

发起方
Acupressure healthcare system hyderabad
申办方类型
Other [Health and beauty shop in Hyderabad ]
责任方
Principal Investigator
主要研究者

Ayushi Gurharikar

VSPM Dental College and Research centre, Nagpur

研究点 (1)

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