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Waiting Room's Environment and Children Anxiety Prior Dental Treatment

Primary Purpose

Dental Anxiety

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
sensory adapted waiting room
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dental Anxiety

Eligibility Criteria

3 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers
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.

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SADE waiting room

Traditional waiting room

Arm Description

children that will wait in the SADE waiting room

children that will wait in the traditional waiting room

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 20, 2017
Last Updated
October 7, 2021
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT03197129
Brief Title
Waiting Room's Environment and Children Anxiety Prior Dental Treatment
Official Title
The Effect of Waiting Room's Environment on the Levels of Anxiety Experienced by Children Prior Dental Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SADE waiting room
Arm Type
Experimental
Arm Description
children that will wait in the SADE waiting room
Arm Title
Traditional waiting room
Arm Type
No Intervention
Arm Description
children that will wait in the traditional waiting room
Intervention Type
Other
Intervention Name(s)
sensory adapted waiting room
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dental Anxiety
Description
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.
Time Frame
Dental anxiety will be assessed while waiting in the waiting room, up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
State/Province
Hadassah
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31888588
Citation
Fux-Noy A, Zohar M, Herzog K, Shmueli A, Halperson E, Moskovitz M, Ram D. The effect of the waiting room's environment on level of anxiety experienced by children prior to dental treatment: a case control study. BMC Oral Health. 2019 Dec 30;19(1):294. doi: 10.1186/s12903-019-0995-y.
Results Reference
derived

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Waiting Room's Environment and Children Anxiety Prior Dental Treatment

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