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临床试验/CTRI/2025/08/092213
CTRI/2025/08/092213尚未招募4 期

Comparative evaluation of tech-enhanced comfort in pediatric dentistry:the impact of photobiomodulation and sensory stimulation on pain and anxiety

SELF1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
SELF
入组人数
30
试验地点
1
主要终点
Reduction in anxiety and pain in children during dental treatment using PBM and eye massager

研究概览

简要总结

This study will include 30 children aged 6–10 years attending their first dental visit at the Department of Pediatric and Preventive Dentistry. After enrollment, each child will be introduced to the operator and assessed for cooperative behavior using the Frankl Behavior Rating Scale to determine eligibility. Baseline measurements will be recorded, including subjective anxiety (RMS-PS) objective anxiety (Facial Image Scale) oxygen saturation and pulse rate.

Participants will be randomly divided into two groups (n  15). Group I will receive Periorbital Eye Massager (PEM) therapy with natural sounds, while Group II will undergo Intranasal Photobiomodulation (IPBM). A crossover design will be implemented, where each group receives the alternate intervention during the second visit.

Pain experienced during local anesthesia will be assessed using the Faces Pain Scale – Revised (FPS-R). Additionally, cooperative behavior, pulse rate, and oxygen saturation will be monitored before and after each procedure. Children’s anxiety will also be assessed pre- and post-operatively using a validated, language-appropriate questionnaire to ensure accurate and culturally sensitive reporting. All the obtained data will be statistically analysed using paired t test.

研究设计

研究类型
Interventional
分配方式
Na
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

  • Children aged 6 to 10 years old.
  • Children with first dental visit..
  • Children who need Local anaesthesia injection for their dental procedure.
  • Children with no prior exposure to dental anesthesia.
  • Children who do not have any neurological, psychological, or hearing impairments.
  • Children whose parents or guardians have provided informed consent to participate in the study.

排除标准

  • Children who refuse to wear the device.
  • Children experiencing severe or acute dental pain.
  • Children with a past history of systemic or psychiatric disorders.

结局指标

主要结局

Reduction in anxiety and pain in children during dental treatment using PBM and eye massager

时间窗: BASELINE

次要结局

未报告次要终点

研究者

发起方
SELF
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Tanisha S

AMES Dental college and hospital

研究点 (1)

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