The Effect of Dream Doctors in Children Undergoing Digestive Endoscopic Procedures
Condition: Gastrointestinal Diseases
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

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.
    

Detailed description: 
      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.

      Pre-Puls Inhibition PPI A computerized human startle response monitoring system (SR-HLAB
      STARTLE REFLEX, San Diego Instruments, San Diego, CA) was used to deliver acoustic startle
      stimuli via headphones and record and score the corresponding electro myographic activity
      from the orbicularis oculi muscle. Two disposable electrodes (sensor area 12 mm2) were placed
      approximately 0.75-1cm below the pupil on the orbicularis oculi muscle and 3rd reference
      electrode on the mastoid bone. The skin area at the electrode site was cleaned with a cotton
      swab saturated with rubbing alcohol, then prepared by gently rubbing a small amount of EEG &
      ECG Skin Prepping Gel (Signa Gel- Parker Laboratories Inc., Fairfield, New jersey, USA), and
      cleaned again with a cotton swab.

      The session (a total of 56 trials) is started with 3 min acclimatization period with a 60 dB
      background noise level that is delivered continuously throughout the test session. The
      session is comprised from two blocks. block1: comprised from randomly delivered six trials of
      single 40 msec 120 dB "pulse alone" startle stimuli in order to evaluate the startle
      response, ten "pre" stimuli (at 74, 78, 82, 86 or 92 dB), and thirty "pre pulse" trials that
      consisted of a single 120 dB pulse preceded (120 msec inter-stimulus-interval) by a 20 msec
      pre pulse of 14, 18, 22, 26 or 32 dB above background (i.e., 74, 78, 82, 86 or 92 dB). Block1
      trials were delivered on average 20 sec inter-trial-interval ITI (15-25 sec, total 46
      trials). Block2: comprised of the last ten trials of "pulse alone" startle, at fixed 2 sec
      ITI in order to evaluate a measure of habituation in response to repeated delivery of the
      startling stimuli. Finally, prepulse inhibition (PPI) was calculated as the percent of the
      habituated response as follows [100-(max response to "pre pulse" trial / max response to
      "pulse alone" trial X 100)]

      GSR - Galvanic Skin Response Electrodermal activity will be measured by the differences of
      the skin conductivity. Two 5 mm electrodes will be placed on fingers 2 and 4 of the
      non-dominant hand. The electrodes will be connected to sensor and amplifying receiver with a
      10Hz sampling rate.

      Different portions of the skin can show differences in conductivity, due to sweat related to
      stress. Thus, measuring the skin conductivity of the non-dominant hand was shown to reduce
      this variability.

      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 and measuring anxiety-related
      biologic indices.

      Patients and Methods: This randomized, controlled study will be conducted with children
      undergoing deep sedation during pediatric upper gastrointestinal endoscopies in the
      Gastroenterology institute of the Emek Medical Center,Afula, Israel. One hundred children
      (age 1-18 years) scheduled to undergo deep sedation and elective gastroscopy will be
      enrolled. During enrollment, the potential clown involvement will be explained to parents.
      Patients will be assigned to one of two groups: Group 1:children and their parents with the
      presence of DD upon arrival to the Gastroenterology institute and throughout the induction of
      sedation, gastroscopy and recovery. Group 2: children and their parents undergoing
      gastroscopy with deep sedation without the presence of a DD.

      The randomization process: In Afula Medical Center, the investigators perform gastroscopies
      weekly. During the study period the investigators will perform the gastroscopies one week
      with the DD and one week without the DD.The patients will not be aware to that fact that in
      some weeks the DD is participating during the sedation induction in some of the patients
      (every other week). The DD will use various methods for entertaining the child and alleviate
      stress according to the child's age. The parents and the children will be given anxiety
      questioners to fill before the induction of sedation. At the end of the gastroscopy the
      parents and the children will be given satisfaction questioners. The children will perform
      Pre-Pulse inhibition (PPI) test and GSR before and after the gastroscopy to assess
      physiological and biological emotional and cognitive consequences. The parents will perform
      PPI test and GSR before, during and after the gastroscopy (no caffeine or nicotine
      consumption will be allowed 30min before examination). The anesthesiologist and the nurse at
      the recovery room will fill a questioner evaluating the behavior of the child during the
      induction of sedation and awakening. While inserting an IV line blood spots will be taken for
      stress hormones: cortisol, epinephrine, and norepinephrine. 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.

      The current study hold two major innovativeness: (a) The effects of DD as part of the medical
      team in gastroscopy in children. (b) The physiological and biological evaluation of the
      emotional and cognitive consequences in children and their parents during gastroscopy.

      Statistical analysis:

      The study design is Mixed design (2X3), with DD as between subject factor (with or without
      DD) and stage of treatment as within subject factor (prior, during and after gastroscopy
      examination).Thus, we will conduct a Two-Way ANOVA (2X3) with post hoc Tukey's test.
      Significant interactions will be further analyzed with One-Way ANOVA. Moreover to relate
      physiological and biological measurement to questioner items, Pearson's correlations will be
      calculated.

      The study schedule:

        1. Recruitment: 1.5 year

        2. Study period: for each patient the study will be held during the day of gastroscopy.

        3. Examination of blood serum by ELISA: 3 months.

      3. Analysis of results: three months 4. Targeted date as to completion of project: two years
      from the study beginning.

      Project staff:

        1. Dr Peleg Sarit - Board certified in Pediatrics and Pediatric Gastroenterology and
           Nutrition.

        2. Dr Rinawi Firas - Board certified in Pediatrics and Pediatric Gastroenterology and
           Nutrition.

        3. Dr Efrat Rachel - Board certified in Anesthesiology and Pediatrics.

        4. Professor Avital Avi - Behavioral Neuroscience Lab, Head.

        5. Mrs Lazimi Ilanit - Pediatric and Pediatric Gastroenterology nurse.

        6. Mr Yaron (Sancho) Goshen - Experienced DD.

        7. Mrs Yaara Tirosh Kamienchick - Research coordinator. Institutional overview: Dr Peleg
           Sarit, Pediatric Gastroenterology Unit, Emek Medical Center, Shderot Itzhak Rabin 21
           Afula, 18101, Israel Phone: +972-4-6494104 Fax: +972-4-6495532 Email:
           Peleg_sa@clalit.org.il

      Ethics:

      The study will be conducted according to the ethical principles of the Declaration of
      Helsinki. Informed consent will be obtained following explicit description of the study
      outline and alternatives for participation. It will be made clear that declining to
      participate in the study will not jeopardize, in any way, the quality of care received. The
      signed consent will be filed in the patient's medical record. The principal investigators
      will have full access to the data prior to publication. CRFs will be identified and coded by
      study number and initials only.
    

Intervention name(s): Sedation of children during gastroscopy with and without the presence of dream doctor; evaluation of stress with PPI and GSR; blood specimens for stress hormones; Physiological indices for evaluation of stress
Intervention type(s): Procedure; Device; Biological; Other
Intervention description(s): 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.
Other intervention name(s): dream doctor; PPI GSR; stress hormones; physiological indices
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Dream Doctors; Medical Clown; Pediatrics; Sedation; Endoscopy