The Effect of Dream Doctors in Children Undergoing Digestive Endoscopic Procedures
1 other identifier
interventional
99
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2016
CompletedFirst Posted
Study publicly available on registry
January 29, 2016
CompletedStudy Start
First participant enrolled
March 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2018
CompletedOctober 3, 2018
October 1, 2018
2.3 years
January 10, 2016
October 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Level of anxiety in children undergoing gastroscopies measured by biological indices (blood pressure)
The following physical indices will be measured: blood pressure (mmHG)
Up to 12 hours during the day of gastroscopy for each patient.
Level of anxiety in children undergoing gastroscopies measured by biological indices (pulse)
The following physical indices will be measured: pulse per minute
Up to 12 hours during the day of gastroscopy for each patient.
Level of anxiety in children undergoing gastroscopies measured by biological indices (saturation)
The following physical indices will be measured: saturation meaning level of oxygen in blood with pulse oximeter in units
Up to 12 hours during the day of gastroscopy for each patient.
Level of anxiety in children undergoing gastroscopies measured by biological indices (body temperature)
The following physical indices will be measured: body temperature in celsius degrees
Up to 12 hours during the day of gastroscopy for each patient.
Level of anxiety in children undergoing gastroscopies measured by biological indices (sedation drug level)
The following physical indices will be measured:The amount of drugs given for deep sedation will be evaluated, in milligrams per kilogram body weight.
Up to 12 hours during the day of gastroscopy for each patient.
level of anxiety in children undergoing gastroscopies and their parents measured by PPI
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.
Up to 12 hours during the day of gastroscopy for each patient.
level of anxiety in children undergoing gastroscopies and their parents measured by GSR
The investigators would use a monitoring device that would assess physiological reactivity by measurement of skin conductance (galvanic skin response).
Up to 12 hours during the day of gastroscopy for each patient.
Study Arms (2)
Children and their parents with the presence of Dream Doctors
ACTIVE COMPARATORThe 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.
Children and their parents without the presence of DD
PLACEBO COMPARATORNo 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.
Interventions
children and their parents with and without the presence of DD upon arrival to the Gastroenterology institute and throughout the induction of sedation, gastroscopy and recovery.
evaluation of stress in children undergoing gastroscopy with sedation with and without the presence of a dream doctor by measurement of PPI and GSR
evaluation of stress in children undergoing gastroscopy with sedation with and without the presence of a dream doctor by measurement of stress hormones.
evaluation of stress in children undergoing gastroscopy with sedation with and without the presence of a dream doctor by measurement of blood pressure, pulse, saturation and body temperature.
Eligibility Criteria
You may qualify if:
- Children aged 1-18 years undergoing gastroscopy.
- Informed consent of the parents
You may not qualify if:
- Developmental delay or neurologic disease
- Children who underwent endoscopy in the past
- Parents that don't agree to participate in the study
- ASA≥3
- Children or parents hearing problem.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emek Medical Center
Afula, 1834111, Israel
Related Publications (5)
Tolia V, Peters JM, Gilger MA. Sedation for pediatric endoscopic procedures. J Pediatr Gastroenterol Nutr. 2000 May;30(5):477-85. doi: 10.1097/00005176-200005000-00003. No abstract available.
PMID: 10817274RESULTSoker Z. Play and Learning: What really children wan't to learn through play? 'Megamot' (Trends) for research. Behav. Sci.1993; 34:497-520.
RESULTPuder C. The healthful effects of laughter. CYC-Net 2003; 55:32-42.
RESULTGolan G, Tighe P, Dobija N, Perel A, Keidan I. Clowns for the prevention of preoperative anxiety in children: a randomized controlled trial. Paediatr Anaesth. 2009 Mar;19(3):262-6. doi: 10.1111/j.1460-9592.2008.02903.x. Epub 2008 Dec 23.
PMID: 19143948RESULTVagnoli L, Caprilli S, Messeri A. Parental presence, clowns or sedative premedication to treat preoperative anxiety in children: what could be the most promising option? Paediatr Anaesth. 2010 Oct;20(10):937-43. doi: 10.1111/j.1460-9592.2010.03403.x.
PMID: 20849499RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarit Peleg, MD
Emek Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Pediatric Gastroenterology Unit
Study Record Dates
First Submitted
January 10, 2016
First Posted
January 29, 2016
Study Start
March 30, 2016
Primary Completion
July 18, 2018
Study Completion
July 18, 2018
Last Updated
October 3, 2018
Record last verified: 2018-10