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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03197129
Other study ID # hadasshmo
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date May 1, 2019

Study information

Verified date February 2020
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The amount of time the patient has spent awaiting treatment and the nature of the waiting room environment influence the anxiety level prior treatment. The objective of the present study is to compare the effect of waiting room's environment on the levels of anxiety experienced by children, in sensory adapted dental environment (SADE) and traditional waiting rooms. A parallel randomized trial. The participants will be randomly assigned to one type of waiting room. The participants will be asked to answer Venham Picture Test (VPT) scale while waiting in the waiting room just before entering the clinic.


Description:

The SADE waiting room: a small waiting room (2.5mx2.5m) inside the clinic with 6 seats. All ceiling fluorescent lighting is removed. The adapted lighting consisted of slow-moving, repetitive visual color effects created by a projector, and a lighting column that children can touch and climb on. Auditory stimuli include rhythmic music, which is heard via loudspeakers. The traditional waiting room: a waiting area outside the clinic with ten seats in one row faces the reception desk in an area of 15 square meters. The area is air-conditioned, moderately well-lit, without posters or paintings on the walls, and no reading material. •Dental anxiety scale- Venham Picture Test (VPT) is widely used and easily administered. In this test, children are presented with eight cards, with two figures on each card, one 'anxious' figure and one 'nonanxious' figure. They are asked to choose the figure from each pair that describes how they feel at that particular time. All cards are shown in their numbered order. If an anxious figure is chosen, a score of one is recorded. If a nonanxious cartoon is chosen, a score of zero is recorded. A measure of anxiety is obtained by totaling the number of times the child picks the cartoons depicting the anxious state (minimum score, 0; maximum score, 8). The participants will be asked to answer while waiting in the waiting room just before entering the clinic. Study design- The study is a parallel randomized trial. The participants will be randomly assigned to one type of waiting room. Additional data- gender, age, the lengths of waiting, the purpose of the visit (examination or treatment with/without sedation), dental experience, type of waiting room, child escort.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date May 1, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 10 Years
Eligibility Inclusion criteria: healthy 3-10 years old boys and girls Exclusion criteria: mentally unable to understand and answer the Venham Picture Test (VPT) to assess anxiety before treatment, accepted immediately without waiting.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
sensory adapted waiting room
The SADE waiting room: a small waiting room (2.5mx2.5m) inside the clinic with 6 seats. A lighting column that children can touch and climb on. Auditory stimuli include rhythmic music, which is heard via loudspeakers.

Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem Hadassah

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dental Anxiety According to Venham Picture Test (VPT) scale. A measure of anxiety is obtained by totaling the number of times the child picks the figure depicting the anxious state :minimum score 0; maximum score 8. A score of 0 means low anxiety, a score of 8 means high anxiety. Dental anxiety will be assessed while waiting in the waiting room, up to 1 hour
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