Trial Outcomes & Findings for Waiting Room's Environment and Children Anxiety Prior Dental Treatment (NCT NCT03197129)

NCT ID: NCT03197129

Last Updated: 2021-11-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 122 participants
• Primary outcome timeframe: Dental anxiety will be assessed while waiting in the waiting room, up to 1 hour
• Results posted on: 2021-11-05

Participant Flow

Participant milestones

Measure	SADE Waiting Room 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.	Traditional Waiting Room 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.
Overall Study STARTED	60	62
Overall Study COMPLETED	56	57
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Measure	SADE Waiting Room 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.	Traditional Waiting Room 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.
Overall Study did not answer the VPT: shyness	4	5

Baseline Characteristics

Drop out

Baseline characteristics by cohort

Measure	SADE Waiting Room n=60 Participants 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.	Traditional Waiting Room n=62 Participants children that will wait in the traditional waiting room	Total n=122 Participants Total of all reporting groups
Age, Continuous	5.63 years STANDARD_DEVIATION 1.87 • n=56 Participants • Drop out	5.73 years STANDARD_DEVIATION 2.1 • n=57 Participants • Drop out	5.68 years STANDARD_DEVIATION 1.98 • n=113 Participants • Drop out
Sex: Female, Male Female	23 Participants n=56 Participants • Drop out	28 Participants n=57 Participants • Drop out	51 Participants n=113 Participants • Drop out
Sex: Female, Male Male	33 Participants n=56 Participants • Drop out	29 Participants n=57 Participants • Drop out	62 Participants n=113 Participants • Drop out
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Israel	56 participants n=60 Participants	57 participants n=62 Participants	113 participants n=122 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	SADE Waiting Room n=56 Participants 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.	Traditional Waiting Room n=57 Participants children that will wait in the traditional waiting room
Dental Anxiety	1.71 units on a scale Standard Deviation 2.27	2 units on a scale Standard Deviation 2.28

Adverse Events

SADE Waiting Room

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Waiting Room

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Avia Fux-Noy

Hadassah School of Dental Medicine, P.O.Box 12272

Phone: +972-2-6776135

Email: fuxavia@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place