NCT02668679

The Effect of Dream Doctors in Children Undergoing Digestive Endoscopic Procedures

Completed NA Last updated 3 October 2018

What this trial tests

NA trial testing Sedation of children during gastroscopy with and without the presence of dream doctor in Gastrointestinal Diseases in 99 participants. Completed in 18 July 2018.

Timeline

30 March 2016

Primary endpoint
18 July 2018

18 July 2018

Quick facts

Lead sponsor	HaEmek Medical Center, Israel
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	99
Start date	30 March 2016
Primary completion	18 July 2018
Estimated completion	18 July 2018
Sites	1 location across Israel

Drugs / interventions tested

• 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 — full drug profile →
• Physiological indices for evaluation of stress

Conditions studied

• Gastrointestinal Diseases — all drugs for Gastrointestinal Diseases →

Sponsor

HaEmek Medical Center, Israel

Who can join

Adults 1 to 18, any sex, with Gastrointestinal Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clowning in children undergoing potentially anxiety-provoking procedures: a systematic review and meta-analysis.
   Könsgen N, Polus S, Rombey T, Pieper D. · · 2019 · cited 12× · PMID 31324215 · DOI 10.1186/s13643-019-1095-4