Effect of Medical Clown Intervention on Anxiety and Perceived Pain Levels in Pediatric Patients Undergoing Venous Blood Draw
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 2-Item anxiety intensity measure
研究概览
简要总结
The research objective of this proposed clinical trial is to determine the efficacy of a medical clowning intervention for pediatric patients undergoing venipuncture. Efficacy is defined in terms of decreasing anxiety, pain, and crying duration, and increasing the pace and ease of the procedure. The study population includes pediatric patients between the ages of 3 - 11 years who must undergo venipuncture at the LAC + USC Outpatient Clinic. The subjects will be randomized into two groups. The control subjects will receive no intervention during blood draw, while the intervention subjects will receive the medical clown intervention during blood draw. The clowns will interact with one patient at a time, engaging in play with the patient and caretakers during all parts of the procedure. Duration of crying and the duration of the entire procedure, the patient's level of pain and anxiety, the caretaker's level of anxiety, need for restraining devices (papoose) and the efficiency of the procedure will be measured. In order to perform the survey and self-assessment procedures, we will implement the use of measurement scales including a novel "emoji" child distress assessment scale, and a published adult anxiety scale (State-Trait Anxiety Inventory Form Y-1). The data will be analyzed using descriptive statistics.
详细描述
The scientific aim of this project is to determine the effect a medical clowning intervention may have on perceived pain levels and anxiety levels with patients, their families, and the medical staff during routine blood draw procedures in the Pediatric Oncology Hematology Clinic of LAC + USC.
We are investigating the following claims: First, the physical, play-based, non-verbal based forms of communication that a clown implements is effective in creating playful distraction during the procedure. The presence of the clown in this capacity can meaningfully reduce perceived pain levels in patients during venipuncture and reduce the duration of crying. Second, the clown intervention decreases anxiety levels in the trial participants and families leading up to and during blood draw which supports the patient as well as increases efficiency for hospital staff. Third, the presence of the clown will significantly reduce physical restraint (i.e. medical stabilization board, known as a papoose board) usage during venipuncture. Lastly, we aim to prove that coulrophobia does not play a factor in medical clowning interventions.
The USC School of Dramatic Arts Medical Clowning Program is the first academic and research program of its kind in the country, offering a groundbreaking opportunity to develop a new model for patient healing and wellness. While research studies have proven its effectiveness internationally, USC hopes to become a leading player by applying, proving, and advocating for the transformational impact of clowning in healthcare. Medical Clowns, Zachary Steel and Caitlyn Conlin, have both been clowning at LAC + USC County Hospital for the past two years. The practice, as perceived by the clown practitioners, staff and family members, has been extremely effective in lowering anxiety, reframing the hospitalization experience, and as a distraction tool. We are hoping to elevate the practice as a vital paramedical profession by proving the efficacy of the practice in this specific setting.
Internationally, the practice of medical clowning has becoming increasingly prevalent in hospital and community settings. The efficacy of the practice continues to be proven, all without undue risk to human subjects, when applied to a large spectrum of populations and settings. At Carmel Medical Center in Haifa, Israel, a study on the effect of medical clowning on reducing pain, crying, and anxiety in children aged 2 to 10 years old undergoing venous blood drawing proved the clowns were effective, safe, and had less negative effect on future blood draw examinations compared with control or use of topical anesthetic. Furthermore, integration of medical clowns in physical examination was shown to improve the overall experience of the child and the caregivers and help the pediatrician to perform a complete physical examination, with shorter duration of discomfort (0.2 +/- 0.6 minutes vs 1.6 +/- 2.0 minutes, p = 0.001); in the medical clown group, 94% of pediatricians reported that the medical clown improved their ability to perform a complete physical examination. Clowning has also successfully been used as a psychological distress buffer during anogenital examinations of sexually abused children.
While the international community has successfully studied the efficacy of the practice, the practice of medical clowning varies from country to country as the patient's response to different forms of humor and play varies. Culturally, clowns play a different role in the United States than they do elsewhere due to coulrophobia (fear of clowns) that has surfaced in the U.S. due to blockbuster movies. In 2017, an Israeli group published a study that showed that only 1.2% of hospitalized children were afraid of clowns. In contrast, according to a poll conducted by Morning Consult 42% of Americans said they were, in some capacity, afraid of clowns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 11 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children whose treatment includes blood tests in the outpatient blood draw facility at LAC + USC Medical Center.
排除标准
- •Participants will be excluded if they have severe developmental disabilities or are both blind and deaf.
研究组 & 干预措施
Intervention group
This arm will receive a medical clowning intervention in addition to pre and post surveys about the blood draw process.
干预措施: Medical Clowning (Behavioral)
Non-intervention group
This arm will continue usual care with no intervention from medical clowns. They will be asked to complete pre and post surveys about the blood draw process.
结局指标
主要结局
2-Item anxiety intensity measure
时间窗: 30 minutes
Compare the difference in self reported scores on the Children's Anxiety and Pain Scale 0-4 prior to and 0-4 following intervention, between control and experimental groups
次要结局
- 2-item pain intensity measure(30 minutes)
研究者
Brent Blair, PhD
Director, Institute for Theatre & Social Change
University of Southern California
