Effect of Sensory Adapted Dental Environment on Children's Behavior During Dental Treatment
- Conditions
- Child Behavior
- Interventions
- Other: SADEOther: RDE
- Registration Number
- NCT03366467
- Lead Sponsor
- Hadassah Medical Organization
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- ASA1
- Needs at least 2 similar dental treatment appointments
- Needs only one dental treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description SADE first SADE SADE first will initially be treated under SADE (Time 1) and receive RDE on the second encounter (Time 2) RDE first SADE RDE first will initially be treated under RDE (Time 1) and receive SADE on the second encounter (Time 2) SADE first RDE SADE first will initially be treated under SADE (Time 1) and receive RDE on the second encounter (Time 2) RDE first RDE RDE first will initially be treated under RDE (Time 1) and receive SADE on the second encounter (Time 2)
- Primary Outcome Measures
Name Time Method Physiologic arousal states Data will be reported through study completion, an average of 2 years Evaluated by palmar electrodermal activity (EDA) during dental treatment
- Secondary Outcome Measures
Name Time Method Anxious behavior-duration Data will be reported through study completion, an average of 2 years Examiner will count the duration, in minute, of the anxious behavior (crying and movements) during dental treatment..
Houpt Scale Data will be reported through study completion, an average of 2 years Rating patient behavior during treatment according to Houpt scale. The Houpt scale is a tool used to assess a child's behavior during dental sedation according to specific categories and scores including: sleep (1-awake, 2-drowsy, disoriented), movement (1-violent, 2-continuous, 3-controllable, 4-no movement), cry (1-hysterical, 2-continuous, 3-intermittent, 4-no cry), and overall behavior (1-treatment aborted, 2-poor, 3-regular, 4-good, 5-very good, 6-excellent).
Anxious behavior-number Data will be reported through study completion, an average of 2 years Examiner will count the number of the anxious behavior episodes (crying and movements) during dental treatment.