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临床试验/NCT06624410
NCT06624410尚未招募不适用

Reduction of Perioperative Anxiety in Spanish-Speaking Children

Oregon Health and Science University0 个研究点目标入组 50 人开始时间: 2025年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Anxiety score using the mYPAS-SF anxiety index

研究概览

简要总结

The goal of this trial is to first evaluate whether a difference exists in anxiety scores between Spanish-speaking children and English-speaking children in the pre-operative setting in our patient population as assessed by the validated myPAS-SF anxiety index. In the interventional phase, the investigators hypothesize that the use of a language-concordant, educational intervention by study participants at home during the week preceding surgery will decrease pre-operative anxiety in Spanish-speaking children, as assessed by the validated mYPAS-SF anxiety index.

详细描述

Rationale: Pre-operative anxiety is a common phenomenon among children as well as their parents with some studies suggesting it occurs in up to 50% of children who are undergoing surgery in the United States (U.S.). Therefore, the prevalence of this phenomenon within the surgical field represents a solvable problem, the elimination of which would be of added benefit to the surgical experience for patients. Beyond the simple unpleasantness of experiencing anxiety, higher levels of pre-operative anxiety have also been shown to associate with worse post-surgical outcomes including increased pain, agitated emergence from anesthesia (emergence delirium) and maladaptive behavioral change. Indeed, this means that addressing pre-operative anxiety could lead to better overall health outcomes post-operatively.

Demographically, the Hispanic / Latino population is one of the fastest growing in the U.S., with a predicted increase by 240% by the year 2060, meaning that one in three US residents will be Hispanic at that time. Our ever-diversifying US population highlights a need for more personalized and culturally considerate medical care, as research has shown that ethnicity, culture, and language may play a role in decision making as well as the patient experience.

Given the association between pre-operative anxiety and worse post-operative outcomes and the fact that Hispanic children with Spanish-speaking parents experience higher levels of pre-operative anxiety as opposed to their white counterparts, the investigators have thus identified a gap in healthcare that leaves Hispanic populations vulnerable to preventable health disparities. Therefore, the purpose of this project is to create an intervention designed specifically for Hispanic, Spanish-speaking children that will lower rates of pre-operative anxiety and thus improve their post-operative outcomes.

Background: To address the problem of pre-operative anxiety in children, it was paramount to develop a valid metric for accurately assessing anxiety level. To assist with measuring anxiety in children before surgery, the modified Yale Preoperative Anxiety Scale (mYPAS) was developed in 1995 and then modified in 1997. This scale uses 5 items, each of which represent a different domain of child anxiety and is used at 4 distinct timepoints throughout the surgical experience. However, though this metric was reliable and accurate, the inclusion of 5 different domains of assessment over 4 timepoints proved to be somewhat redundant and cumbersome to use in a hectic surgical setting. Therefore, in 2014, Jenkins et al. developed a short form version of the mYPAS, aptly renamed mYPAS-SF through elimination of areas of redundancy and only administered at 2 time points instead of 4. Use of this metric has helped identify characteristics which may correspond to higher levels of anxiety such as younger age, a shyer temperament, an established history of surgery, and miscellaneous parental factors.

Once a reliable metric for assessing pre-operative anxiety in children was established, various experimental interventions were developed and introduced to children pre-operatively like listening to calming music or encouragement of participation in recreation beforehand, both of which had a significant impact on the reduction of pre-operative anxiety. However, an inherent problem with these studies is that most of them are conducted on primarily white, English-speaking children or their parents which limits their generalizability. Indeed, research has confirmed that cultural consideration is necessary; Hispanic children with Spanish-speaking parents experience higher levels of pre-operative anxiety as compared to white children with English-speaking parents. This is not exclusively limited to children, but to their parents as well. Fortier et al., specifically concluded that "Spanish-speaking Hispanic parents exhibited higher levels of anxiety and this correlates to higher levels of preoperative anxiety in their children". These differences represent a gap in healthcare that could be filled through tailored delivery of interventions pre-operatively which reduce Hispanic children's anxiety and will correspond to better outcomes post-operatively.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

Anesthesia providers, nurse providers, and surgical providers will be masked. The outcome assessor will be masked. The subject and their parent cannot be masked, due to the nature of the study. We will request of our subjects and parents/guardians to not inform their pre-operative nurse as to their allocation.

入排标准

年龄范围
5 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Hispanic/Latino Spanish-Speaking children ages 5-14 years
  • Undergoing surgery in the Doernbecher Operating Rooms

排除标准

  • Subjects having cardiac surgery
  • Parent refusal of consent
  • Children that refuse assent
  • Children with psychiatric or atypical neurodevelopmental conditions such as autism or sensory processing disorders that put them at greater risk for pre-surgical anxiety, history of prior surgery, and children with global developmental delay as noted by ICD codes or diagnosis on their problem list
  • Parent/Guardian Exclusion Criteria
  • Impaired decision-making adults
  • Incarcerated adults

结局指标

主要结局

Anxiety score using the mYPAS-SF anxiety index

时间窗: On average 1-2 weeks. From enrollment to day of surgery.

Pre-operative anxiety levels will be assessed with the mYPAS-SF6-12 (below). Subjects will be observed for behaviors and then given a score out of possible 5 across 5 domains that corresponds with demonstrated behaviors, specified in the figure below. The 5 domains include Activity, Vocalization, Emotional Expressivity, State of Arousal, and Use of Parent. Note that the "Vocalization" domain differs in that It's possible scores range from 1-7. Pilot data collection will involve mYPAS scoring in isolation to demonstrate existing anxiety burden at Doernbecher Children's Hospital.

次要结局

  • Post-operative/Emergence Delirium(Up to 24 hours)
  • VAS pain score(Up to 1 week)
  • Morphine equivalents(Up to 1 week)

研究者

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

Tomas Lazo

Associate Professor

Oregon Health and Science University

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