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

Child Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03366467
• Other study ID #: 0469-17-HMO
• Status: Withdrawn
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: March 22, 2022

Study information

• Verified date: March 2022
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 22, 2022
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

Inclusion Criteria:

• ASA1

• Needs at least 2 similar dental treatment appointments

Exclusion Criteria:

• Needs only one dental treatment

Related Conditions & MeSH terms

• Child Behavior

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiologic arousal states	Evaluated by palmar electrodermal activity (EDA) during dental treatment	Data will be reported through study completion, an average of 2 years
Secondary	Houpt Scale	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).	Data will be reported through study completion, an average of 2 years
Secondary	Anxious behavior-number	Examiner will count the number of the anxious behavior episodes (crying and movements) during dental treatment.	Data will be reported through study completion, an average of 2 years
Secondary	Anxious behavior-duration	Examiner will count the duration, in minute, of the anxious behavior (crying and movements) during dental treatment..	Data will be reported through study completion, an average of 2 years