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临床试验/NCT06761833
NCT06761833尚未招募不适用

The Effect of Preoperative Anxiety on Postoperative Behavioral Changes in Children Receiving Dental Treatment Under General Anesthesia

Baskent University1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2025年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
260
试验地点
1
主要终点
The effect of preoperative anxiety level on postoperative behavioral changes in children receiving dental treatment under general anesthesia.

研究概览

简要总结

In children scheduled for dental treatment, negative thoughts can lead to anxiety and make them resistant to treatment techniques. In our prospective, single-center observational study, we aim to investigate preoperative anxiety and postoperative negative behaviors in children aged 3 to 12 years who are set to undergo general anesthesia for dental conditions and treatments.

详细描述

The study will involve children aged 3 to 12 who have been classified under the American Society of Anesthesiologists (ASA) as I-II. These children, scheduled for dental treatment between January 2025 and January 2026 at Başkent University Adana's Turgut Noyan Practice and Research Hospital, will undergo elective surgery under general anesthesia. Parental consent will be obtained prior to their inclusion in the research.

The assessment of preoperative anxiety levels in patients will be conducted using the Modified Yale Preoperative Anxiety Scale (m-YPAS). This evaluation will take place in the presence of their families within the anesthesia outpatient clinic and the preoperative preparation room on the day of surgery. The m-YPAS is structured into five categories: Activity, Speech, Emotional State, Awaking State, and Parent-Related Reactions, comprising a total of 22 items. The scoring for the Modified Yale Preoperative Anxiety Scale ranges from 5 to 22 points, with each item assigned a single point. Research has demonstrated that the Turkish validation of the m-YPAS is a valid and reliable tool for assessing preoperative anxiety in children aged 5 to 12 years.

Induction of general anesthesia will be standardized for all patients. The Bispectral Index (BIS) will be kept between 40- 60. All patients will receive standard local anesthetic by the pedodontist during the operation. The anesthesia physician will evaluate delirium using the Pediatric Postoperative Delirium Scale (PAED) at 1 minute post-surgery and every 10 minutes thereafter until the patient is transferred to the ward. The PAED scale has been used in Turkish studies to assess postoperative delirium. İn the absence of complications during the patient's follow-up in the ward, the patient will be discharged on the same day. To evaluate behavioral changes in children during the preoperative period, parents will be provided with information regarding the 11 item Post-Hospital Discharge Behavior Questionnaire ( PHBQ-AS) in the outpatient clinic. Parents will be requested to compare their children's behavior prior to hospitalization with their behavior following discharge for each item on the questionnaire. Additionally, follow-up phone calls will be conducted on the 2nd, 15th, and 30th days after discharge to collect and record survey results.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients categorized as American Society of Anesthesiologists (ASA) groups 1 and
  • Children aged 3 to 12 years who are scheduled to receive dental treatment under general anesthesia.

排除标准

  • The child patient or parent has a diagnosed psychiatric disorder.
  • There is a history of substance use that may affect cognitive function.
  • The parent has declined to participate in the study.
  • The child patient or parent does not speak Turkish.
  • Patients categorized as American Society of Anesthesiologists (ASA) group 3 and 4.

结局指标

主要结局

The effect of preoperative anxiety level on postoperative behavioral changes in children receiving dental treatment under general anesthesia.

时间窗: one year

This observational study, conducted at a single center, aims to investigate the occurrence of negative postoperative behavior in children

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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