Clinical trial NCT03366467: Effect of Sensory Adapted Dental Environment on Children's Behavior During Dental Treatment
Official title: Effect of Sensory Adapted Dental Environment on Children's Behavior During Dental Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Child Behavior
Keywords: dental treatment
sensory adapted environment
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The participants will be randomly assigned into two groups. Group 1 will initially be treated under SADE (Time 1) and receive RDE on the second encounter (Time 2). For the second group, the procedure is reversed (RDE at Time 1 and SADE at Time 2).
Primary purpose: OTHER

Brief summary: The objective of the present study is to determine the effect of sensory adapted dental environment (SADE) in healthy children during a routine dental restorative treatment. The hypothesis is that the SADE would have a favorable effect in calming the subjects during dental treatment.

the study is a random cross-over design. The participants will be randomly assigned into two groups. Group 1 will initially be treated under SADE (Time 1) and receive regular dental environment (RDE) on the second encounter (Time 2). For the second group, the procedure is reversed (RDE at Time 1 and SADE at Time 2).

Detailed description: * Dental treatment- will include restorations, crowns, pulp treatment, with local anesthesia. The use of oral/inhaled sedation will be decided according to the patient's behavior and cooperation assessment.
* Dental settings- The SADE: the sensory stimuli addressed are visual and auditory, as follows: (i) Visual sensation. All ceiling fluorescent lighting are removed. The adapted lighting consisted of slow-moving, repetitive visual color effects created by a projector, in the child's visual field. (ii) Auditory stimuli include rhythmic music, which was heard via loudspeakers. The RDE utilized fluorescent lighting on the ceiling, without special visual effects and without music stimulation.
* Instruments- 1) the children will be observed during the treatments. The observer will code all behaviors according to the Houpt Scale used for rating patient behavior during treatment. In addition, the examiner will count the number and duration (in minutes) of the anxious behavior (crying and movements). Because of the nature of the study (one environment with sensory adaptation and the other without), the observer cannot be blind to the treatment environment. 2) Physiologic arousal states, evaluated by the assessment of EDA (Mindlife Co, Jerusalem, Israel). Changes in the electrical conductance of the skin are a sensitive way of monitoring autonomic responses to external stimuli.

Eligibility criteria: Inclusion Criteria:

* ASA1
* Needs at least 2 similar dental treatment appointments

Exclusion Criteria:

* Needs only one dental treatment

Primary outcomes:
measure: Physiologic arousal states
timeFrame: Data will be reported through study completion, an average of 2 years
Secondary outcomes:
measure: Houpt Scale
timeFrame: Data will be reported through study completion, an average of 2 years
measure: Anxious behavior-number
timeFrame: Data will be reported through study completion, an average of 2 years
measure: Anxious behavior-duration
timeFrame: Data will be reported through study completion, an average of 2 years
Other outcomes:
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