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

NCT ID: NCT03366467

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-22
• Study Completion Date: 2022-03-22

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.

Conditions

Child Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

SADE first

SADE first will initially be treated under SADE (Time 1) and receive RDE on the second encounter (Time 2)

Group Type: EXPERIMENTAL

SADE

Intervention Type: OTHER

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.

RDE

Intervention Type: OTHER

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

RDE first

RDE first will initially be treated under RDE (Time 1) and receive SADE on the second encounter (Time 2)

Group Type: EXPERIMENTAL

SADE

Intervention Type: OTHER

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.

RDE

Intervention Type: OTHER

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

Interventions

SADE

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.

Intervention Type: OTHER

RDE

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ASA1
• Needs at least 2 similar dental treatment appointments

Exclusion Criteria

• Needs only one dental treatment

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Avia Fux

pediatric dentist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

0469-17-HMO

Identifier Type: -

Identifier Source: org_study_id