Waiting Room's Environment and Children Anxiety Prior Dental Treatment

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Completed
• CT.gov ID: NCT03197129
• Collaborator: (none)
• Enrollment: 122
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.9
• Patients Per Site Per Month: 7.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Anxiety	Other: sensory adapted waiting room	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The Effect of Waiting Room's Environment on the Levels of Anxiety Experienced by Children Prior Dental Treatment
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Jan 31, 2019
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SADE waiting room children that will wait in the SADE waiting room	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.
No Intervention: Traditional waiting room children that will wait in the traditional waiting room

Outcome Measures

Primary Outcome Measures

1. Dental Anxiety [Dental anxiety will be assessed while waiting in the waiting room, up to 1 hour]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization	Jerusalem	Hadassah	Israel	91120

Sponsors and Collaborators

• Hadassah Medical Organization

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 23, 2017

More Information

Publications

None provided.

• Responsible Party: Hadassah Medical Organization
• ClinicalTrials.gov Identifier: NCT03197129
• Other Study ID Numbers: hadasshmo
• First Posted: Jun 23, 2017
• Last Update Posted: Nov 5, 2021
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

Participant Flow

Arm/Group Title	SADE Waiting Room	Traditional Waiting Room
Arm/Group Description	children that will wait in the SADE waiting room 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.	children that will wait in the traditional waiting room This waiting room consisted of ten seats in one row facing the reception desk, and was air-conditioned, well-lit, without posters or paintings on the walls, and no reading material.
Period Title: Overall Study
STARTED	60	62
COMPLETED	56	57
NOT COMPLETED	4	5

Baseline Characteristics

Arm/Group Title	SADE Waiting Room	Traditional Waiting Room	Total
Arm/Group Description	children that will wait in the SADE waiting room 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.	children that will wait in the traditional waiting room	Total of all reporting groups
Overall Participants	60	62	122
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.63 (1.87)	5.73 (2.1)	5.68 (1.98)
Sex: Female, Male (Count of Participants)
Female	23 38.3%	28 45.2%	51 41.8%
Male	33 55%	29 46.8%	62 50.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Israel	56 93.3%	57 91.9%	113 92.6%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SADE Waiting Room	Traditional Waiting Room
Arm/Group Description	children that will wait in the SADE waiting room 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.	children that will wait in the traditional waiting room
Measure Participants	56	57
Mean (Standard Deviation) [units on a scale]	1.71 (2.27)	2 (2.28)

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	no adverse events
Arm/Group Title	SADE Waiting Room		Traditional Waiting Room
Arm/Group Description	children that will wait in the SADE waiting room 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.		children that will wait in the traditional waiting room This waiting room consisted of ten seats in one row facing the reception desk, and was air-conditioned, well-lit, without posters or paintings on the walls, and no reading material.
All Cause Mortality
	SADE Waiting Room		Traditional Waiting Room
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/57 (0%)
Serious Adverse Events
	SADE Waiting Room		Traditional Waiting Room
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/57 (0%)
Other (Not Including Serious) Adverse Events
	SADE Waiting Room		Traditional Waiting Room
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/57 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.