Comparison of the Effects of Personal Versus Hospital-Provided Dolls on Preoperative Anxiety and Postoperative Delirium in Preschool Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Preoperative Anxiety Level
研究概览
简要总结
The goal of this study is to evaluate the effects of personal versus hospital-provided dolls on preoperative anxiety and postoperative delirium in preschool children aged 3-7 years undergoing elective adenoidectomy and/or tonsillectomy.
The main questions it aims to answer are:
- Is the use of a personal doll or a hospital-provided doll associated with lower preoperative anxiety compared with no doll use?
- Is dolls used associated with a reduced incidence and severity of postoperative emergence delirium?
- Researchers will compare children accompanied by a hospital-provided doll, children accompanied by their personal doll, and children with no doll to assess differences in preoperative anxiety levels, serum cortisol concentrations, and postoperative delirium scores.
Participants will:
- Be observed in one of three exposure groups (hospital-provided doll, personal doll, or no doll)
- Undergo standardized preoperative anxiety assessments at predefined time points
- Have serum cortisol levels measured during routine intravenous cannulation
- Be assessed for postoperative delirium in the recovery unit
详细描述
This study is designed to evaluate the association between doll use and preoperative anxiety as well as postoperative emergence delirium in preschool children undergoing elective adenoidectomy and/or tonsillectomy. The study population consists of female children aged 3-7 years who meet the eligibility criteria and are scheduled for elective surgery under general anesthesia.
Participants will be observed in one of three exposure groups based on routine perioperative practice and parental preference: children accompanied by a hospital-provided doll, children accompanied by their personal doll, and children with no doll use. No intervention will be assigned by the investigators, and standard perioperative care will be maintained for all participants.
Preoperative anxiety will be assessed at four predefined time points: in the waiting area (T0), immediately before transfer to the operating room (T1), in the operating room corridor (T2), and just before anesthesia induction (T3). Anxiety levels will be evaluated using the modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A).
As a biochemical marker of stress response, serum cortisol levels will be measured from an additional blood sample obtained during routine intravenous cannulation performed for clinical purposes. No additional invasive procedures will be required for study-related assessments.
Postoperative emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium Scale (PAED) at three points: immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission (P2).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female children aged 3-7 years
- •Scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia
- •Able to communicate verbally
- •ASA physical status I or II, according to the American Society of Anesthesiologists classification
- •Written informed consent obtained from a parent or legal guardian
排除标准
- •Presence of psychiatric, neurological, or developmental disorders
- •Presence of chronic pain or ongoing medical treatment that may affect anxiety levels
- •Refusal to participate despite repeated encouragement by the investigators
- •Use of additional anxiety-reducing methods or medications outside the study protocol prior to intervention
- •Previous surgical experience
研究组 & 干预措施
Hospital-Provided Doll Group
Participants in this cohort will consist of preschool children accompanied by a hospital-provided doll during the preoperative period. Preoperative anxiety levels, serum cortisol concentrations, and postoperative emergence delirium will be assessed as part of routine perioperative observation.
干预措施: Hospital-Provided Doll (Other)
Personal Doll Group
Participants in this cohort will consist of preschool children accompanied by their own personal doll during the preoperative period. Preoperative anxiety levels, serum cortisol concentrations, and postoperative emergence delirium will be evaluated using standardized assessment tools.
干预措施: Personal Doll (Other)
No Doll (Control) Group
Participants in this cohort will consist of preschool children who will undergo the surgical process without the use of any doll. Preoperative anxiety, serum cortisol levels, and postoperative emergence delirium will be observed and recorded for comparison purposes.
干预措施: No Doll (Other)
结局指标
主要结局
Preoperative Anxiety Level
时间窗: Waiting area (T0), immediately before transfer to the operating room (T1), operating room corridor (T2), and just before anesthesia induction (T3)
Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A) during the preoperative period. Preoperative anxiety will be assessed using m-YPAS, (score range 23-100) and VAS-A (score range 0-10), with higher scores indicating increased anxiety severity.
次要结局
- Postoperative Emergence Delirium(Immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission (P2))
研究者
Filiz Kaya
M.D.
Ankara City Hospital Bilkent