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Effect of Sensory Adapted Dental Environment on Children's Behavior During Dental Treatment

Effect of Sensory Adapted Dental Environment on Children's Behavior During Dental Treatment

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03366467
Enrollment
0
Registered
2017-12-08
Start date
2022-03-22
Completion date
2022-03-22
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Behavior

Keywords

dental treatment, sensory adapted environment

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.

Interventions

OTHERSADE

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.

OTHERRDE

The RDE utilized fluorescent lighting on the ceiling, without special visual effects and without music stimulation.

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

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).

Eligibility

Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
Yes

Inclusion criteria

* ASA1 * Needs at least 2 similar dental treatment appointments

Exclusion criteria

* Needs only one dental treatment

Design outcomes

Primary

MeasureTime frameDescription
Physiologic arousal statesData will be reported through study completion, an average of 2 yearsEvaluated by palmar electrodermal activity (EDA) during dental treatment

Secondary

MeasureTime frameDescription
Houpt ScaleData will be reported through study completion, an average of 2 yearsRating 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-numberData will be reported through study completion, an average of 2 yearsExaminer will count the number of the anxious behavior episodes (crying and movements) during dental treatment.
Anxious behavior-durationData will be reported through study completion, an average of 2 yearsExaminer will count the duration, in minute, of the anxious behavior (crying and movements) during dental treatment..

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026