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临床试验/CTRI/2024/07/071039
CTRI/2024/07/071039已完成2 期

assessment of salivary cortisol level as stress biomarker in anxious pediatric dental patient before and after sandalwood aromatherapy: a randomized clinical trial

Selfsponsored1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
measurement of salivary cortisol levels before and after sandalwood aromatherapy to assess its effect on stress reduction in pediatric dental patients

研究概览

简要总结

This randomized clinical trial aims to investigate the effectiveness of sandalwood aromatherapy in reducing stress levels among pediatric dental patients. The study will assess salivary cortisol levels as a biomarker of stress before and after the intervention. Children without underlying medical conditions who experience anxiety during dental procedures will be enrolled. The intervention group will receive sandalwood aromatherapy, while the control group will receive standard care without aromatherapy. Various time points will be measured on the same day, including baseline, immediately post-intervention, and at intervals thereafter. Secondary outcomes may include physiological parameters such as heart rate variability and subjective measures of patient comfort and satisfaction.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • Healthy children of age group 6–9 years visiting the Department of Pediatric and Preventive Dentistry of NIMS Dental College, Jaipur with routine dental treatments like restoration with no previous dental experience.
  • Children who are Frankel + ve or Frankel–ve in cooperation.

排除标准

  • Medically compromised and special children.
  • Children with any respiratory tract illnesses or cardiac problems, common cold, allergy, and acute dental pain.

结局指标

主要结局

measurement of salivary cortisol levels before and after sandalwood aromatherapy to assess its effect on stress reduction in pediatric dental patients

时间窗: baseline interventions (before intervention) | immediately after intervention | 30 mintues post intervention | 1 hour post intervention

次要结局

未报告次要终点

研究者

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

Dr Chaya Chhabra

NIMS university jaipur rajasthan

研究点 (1)

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