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临床试验/NCT05369936
NCT05369936已完成不适用

Pain Perception: on Relationships Between Dental Anxiety and Olfaction

Qassim University2 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2018年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
350
试验地点
2
主要终点
Anxiety score

研究概览

简要总结

the objective of this study is to evaluate the ability of olfaction in obtaining positive emotional and behavioral responses toward dental anxiety and pain in patients undergoing different dental procedures.

详细描述

All patients who meet inclusion criteria of the study will be given a written consent and enrolled into a randomized double-blinded controlled study (investigator and patients are blinded about the study). Patients will be divided into lavender and control groups. Patients in lavender group will subjected 2 % lavender vapors. In control group, patients will inhale distal water vapors

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The randomization will be performed according to patients' sequences where all odd numbers of patients will be incorporated into control group, while even numbers will be included in lavender group. The patients will not be informed about the type of the essential oil. T This was achieved by inserting lavender vaporizers in all setting rooms and clinics. So that the patients will believe that there is no extraordinary maneuver in the clinics. Also, all the dentists who treated the patients and evaluators who will interview the patients and questionnaires, will not be informed of the type of the essential oil which will be used. The statistician who will analyze the questionnaires will be informed that the study's groups are named as group A or B.

入排标准

年龄范围
19 Years 至 25 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult females over 18 years,
  • Attending morning sessions of clinics (9 am)
  • Liable for administration of local anesthesia, tooth preparation either for filling procedures or crown preparations, endodontic treatment, teeth extraction, or subgingival scaling

排除标准

  • Females who had allergies, bronchial asthma, common cold, pulmonary diseases, migraine, or taking antidepressants, anxiolytic drugs, opioids, or other medications that affect our results

结局指标

主要结局

Anxiety score

时间窗: 24 hours After exposure to vapors

This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety

次要结局

  • Pain Score(24 hours after exposure to vapors)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghada Khalifa

Professor of Maxillofacial Surgery and Diagnostic Science

Qassim University

研究点 (2)

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