The Effect of Dream Doctors in Children Undergoing Digestive Endoscopic Procedures: Physiological and Biological Assessment of Emotional and Cognitive Consequences
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Level of anxiety in children undergoing gastroscopies measured by biological indices (saturation)
研究概览
简要总结
Background: Performance of endoscopy in children requires more patience, experience, and expertise than in adults. The anxiety of the children is related to parent's separation, loss of self-control, unknown surroundings and strange people that are taking care of them, and frequently unpleasant or even painful procedures. Painful and frightening procedures in children have been shown to result in short-term physiologic changes and long-term behavioral changes. The response to unpleasant stimuli with stress and fear may be exaggerated in children and experienced as pain. Most infants and children and many teenagers need deep sedation or light general anesthesia to complete a successful and safe procedure. Induction of general anesthesia is a stressful procedure itself. Strategies to reduce preanesthesia anxiety include pharmacologic and non-pharmacologic interventions.
However, this evidence is based mainly on self reports rather than objective measurements. Therefore, objective and non-invasive measurements to be utilized in the current study, should provide an assessment tools regardless the children's age.
Multiple studies, beginning in the 1970's, have shown that humor has many positive effects on physical and mental health and well-being. Previous investigations have reported that humor has beneficial effects on the immune system, stress related to potentially fatal illnesses, pain tolerance, and mental functions.
Dream doctors (DDs) are professional medical clowns or stage artists, who received training specifically to understand medical patient's need and to give the patient adjuvant therapy during hospital admissions or ambulatory treatment.The Israel dream doctors project, integrates professional medical clowning into the medical services provided at Israeli hospitals.Studies already proved that presence of medical clowns significantly reduces the level of anxiety during induction of anesthesia in children. Hypothesis of the study: 1) DDs lessen the level of anxiety and attention impairment in children undergoing gastroscopies. 2) DDs improve the satisfaction of children and their parents during gastroscopies.
The aim of this study is: 1) To explore the influence of DDs on the satisfaction of children and their parents undergoing gastroscopy, utilizing questioners. 2) To explore the effects of DDs on anxiety and attention of children and their parents, undergoing gastroscopies by means of GSR, startle response and pre-pulse inhibition (PPI) tests, as well as , and measuring anxiety-related biologic indices.
详细描述
The effect of Dream Doctors in children undergoing digestive endoscopic procedures: Physiological and biological assessment of emotional and cognitive consequences.
Background: Since the advent of pediatric gastrointestinal endoscopy in the early 1970's, there has been a remarkable increase in the number of diagnostic and therapeutic procedures performed in infants and children. Performance of endoscopy in children requires more patience, experience, and expertise than in adults. The anxiety of the children is related to parent's separation, loss of self-control, unknown surroundings and strange people that are taking care of them, and frequently unpleasant or even painful procedures. Painful and frightening procedures in children have been shown to result in short-term physiologic changes and long-term behavioral changes. The response to unpleasant stimuli with stress and fear may be exaggerated in children and experienced as pain. Most infants and children and many teenagers need deep sedation or light general anesthesia to complete a successful and safe procedure. Induction of general anesthesia is a stressful procedure itself. Strategies to reduce preanesthesia anxiety include pharmacologic and non-pharmacologic interventions.
However, this evidence is based mainly on self reports rather than objective measurements. Therefore, objective and non-invasive measurements to be utilized in the current study, should provide an assessment tools regardless the children's age.
Multiple studies, beginning in the 1970's, have shown that humor has many positive effects on physical and mental health and well-being. Previous investigations have reported that humor has beneficial effects on the immune system, stress related to potentially fatal illnesses, pain tolerance, and mental functions.
Dream doctors are professional medical clowns or stage artists, who received training specifically to understand medical patient's need and to give the patient adjuvant therapy during hospital admissions or ambulatory treatment. Laughter has physiological effects on different body mechanisms and it affects the cardiovascular system (decreasing heart rate and blood pressure), strengthens the immune system, and lowers level of stress hormones like Norepinephrine. Humor can also help in strengthening the bond between therapist and patient and reduce stress and anxiety and enhance recovery. The Israel dream doctors project, integrates professional medical clowning into the medical services provided at Israeli hospitals. The DDs are part of the multidisciplinary staff, principally but not only, in pediatric wards. Studies already proved that presence of medical clowns significantly reduces the level of anxiety during induction of anesthesia in children. In the pediatric ward in Afula Medical Center, the investigators have experience with DDs for preparing children to kidney scans.
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
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1-18 years undergoing gastroscopy.
- •Informed consent of the parents
排除标准
- •Developmental delay or neurologic disease
- •Children who underwent endoscopy in the past
- •Parents that don't agree to participate in the study
- •Children or parents hearing problem.
研究组 & 干预措施
Children and their parents with the presence of Dream Doctors
The DD will use various methods for entertaining the child and alleviate stress . The parents and the children will be given anxiety and satisfaction questionnaires. The children and parents will perform Pre-Pulse inhibition (PPI) test and GSR. In addition, stress hormones will be assessed (cortisol, epinephrine, and norepinephrine) and the following physical indices will be measured: blood pressure, pulse, saturation and body temperature. The amount of drugs given for deep sedation will be evaluated.
干预措施: Sedation of children during gastroscopy with and without the presence of dream doctor (Procedure)
Children and their parents with the presence of Dream Doctors
The DD will use various methods for entertaining the child and alleviate stress . The parents and the children will be given anxiety and satisfaction questionnaires. The children and parents will perform Pre-Pulse inhibition (PPI) test and GSR. In addition, stress hormones will be assessed (cortisol, epinephrine, and norepinephrine) and the following physical indices will be measured: blood pressure, pulse, saturation and body temperature. The amount of drugs given for deep sedation will be evaluated.
干预措施: evaluation of stress with PPI and GSR (Device)
Children and their parents with the presence of Dream Doctors
The DD will use various methods for entertaining the child and alleviate stress . The parents and the children will be given anxiety and satisfaction questionnaires. The children and parents will perform Pre-Pulse inhibition (PPI) test and GSR. In addition, stress hormones will be assessed (cortisol, epinephrine, and norepinephrine) and the following physical indices will be measured: blood pressure, pulse, saturation and body temperature. The amount of drugs given for deep sedation will be evaluated.
干预措施: blood specimens for stress hormones (Biological)
Children and their parents with the presence of Dream Doctors
The DD will use various methods for entertaining the child and alleviate stress . The parents and the children will be given anxiety and satisfaction questionnaires. The children and parents will perform Pre-Pulse inhibition (PPI) test and GSR. In addition, stress hormones will be assessed (cortisol, epinephrine, and norepinephrine) and the following physical indices will be measured: blood pressure, pulse, saturation and body temperature. The amount of drugs given for deep sedation will be evaluated.
干预措施: Physiological indices for evaluation of stress (Other)
Children and their parents without the presence of DD
No DD during the gastroscopy. The parents and the children will be given anxiety and satisfaction questionnaires. The children and parents will perform Pre-Pulse inhibition (PPI) test and GSR. In addition, stress hormones will be assessed (cortisol, epinephrine, and norepinephrine) and the following physical indices will be measured: blood pressure, pulse, saturation and body temperature. The amount of drugs given for deep sedation will be evaluated.
干预措施: Sedation of children during gastroscopy with and without the presence of dream doctor (Procedure)
Children and their parents without the presence of DD
No DD during the gastroscopy. The parents and the children will be given anxiety and satisfaction questionnaires. The children and parents will perform Pre-Pulse inhibition (PPI) test and GSR. In addition, stress hormones will be assessed (cortisol, epinephrine, and norepinephrine) and the following physical indices will be measured: blood pressure, pulse, saturation and body temperature. The amount of drugs given for deep sedation will be evaluated.
干预措施: evaluation of stress with PPI and GSR (Device)
Children and their parents without the presence of DD
No DD during the gastroscopy. The parents and the children will be given anxiety and satisfaction questionnaires. The children and parents will perform Pre-Pulse inhibition (PPI) test and GSR. In addition, stress hormones will be assessed (cortisol, epinephrine, and norepinephrine) and the following physical indices will be measured: blood pressure, pulse, saturation and body temperature. The amount of drugs given for deep sedation will be evaluated.
干预措施: blood specimens for stress hormones (Biological)
Children and their parents without the presence of DD
No DD during the gastroscopy. The parents and the children will be given anxiety and satisfaction questionnaires. The children and parents will perform Pre-Pulse inhibition (PPI) test and GSR. In addition, stress hormones will be assessed (cortisol, epinephrine, and norepinephrine) and the following physical indices will be measured: blood pressure, pulse, saturation and body temperature. The amount of drugs given for deep sedation will be evaluated.
干预措施: Physiological indices for evaluation of stress (Other)
结局指标
主要结局
Level of anxiety in children undergoing gastroscopies measured by biological indices (saturation)
时间窗: Up to 12 hours during the day of gastroscopy for each patient.
The following physical indices will be measured: saturation meaning level of oxygen in blood with pulse oximeter in units
Level of anxiety in children undergoing gastroscopies measured by biological indices (blood pressure)
时间窗: Up to 12 hours during the day of gastroscopy for each patient.
The following physical indices will be measured: blood pressure (mmHG)
Level of anxiety in children undergoing gastroscopies measured by biological indices (pulse)
时间窗: Up to 12 hours during the day of gastroscopy for each patient.
The following physical indices will be measured: pulse per minute
Level of anxiety in children undergoing gastroscopies measured by biological indices (body temperature)
时间窗: Up to 12 hours during the day of gastroscopy for each patient.
The following physical indices will be measured: body temperature in celsius degrees
Level of anxiety in children undergoing gastroscopies measured by biological indices (sedation drug level)
时间窗: Up to 12 hours during the day of gastroscopy for each patient.
The following physical indices will be measured:The amount of drugs given for deep sedation will be evaluated, in milligrams per kilogram body weight.
level of anxiety in children undergoing gastroscopies and their parents measured by PPI
时间窗: Up to 12 hours during the day of gastroscopy for each patient.
The investigators would use a monitoring device that would assess startle reflex reaction measured by blinking of the eye. Monitoring would be done with electrodes of EMG device that would be located on orbicularis oculi muscle and will monitor response. Startle reflex response (anxiety)- Assessed by millivolts registered by electromyography (EMG) electrodes.
level of anxiety in children undergoing gastroscopies and their parents measured by GSR
时间窗: Up to 12 hours during the day of gastroscopy for each patient.
The investigators would use a monitoring device that would assess physiological reactivity by measurement of skin conductance (galvanic skin response).
次要结局
未报告次要终点
研究者
Sarit Peleg
Head of Pediatric Gastroenterology Unit
HaEmek Medical Center, Israel