NCT03197129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

November 5, 2021

Completed
Last Updated

November 5, 2021

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

June 20, 2017

Results QC Date

March 24, 2021

Last Update Submit

October 7, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

SADE waiting room

EXPERIMENTAL

children that will wait in the SADE waiting room

Other: sensory adapted waiting room

Traditional waiting room

NO INTERVENTION

children that will wait in the traditional waiting room

Interventions

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.

SADE waiting room

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Hadassah, 91120, Israel

Location

Related Publications (1)

  • 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 Point of Contact

Title
Dr. Avia Fux-Noy
Organization
Hadassah School of Dental Medicine, P.O.Box 12272

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 23, 2017

Study Start

January 1, 2018

Primary Completion

January 31, 2019

Study Completion

May 1, 2019

Last Updated

November 5, 2021

Results First Posted

November 5, 2021

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations