NCT06966726

Brief Summary

This randomized triple-blind clinical trial aims to evaluate the effectiveness of positive pre-visit imagery in managing dental anxiety (DA) in children aged 5 to 13 years. DA is a common barrier to dental treatment and is often triggered by procedures such as local anaesthesia. Participants were randomly assigned to view either positive dental images or neutral nature images before treatment. Anxiety levels were assessed before and after the procedure using the Venham Picture Test. The study hypothesizes that exposure to positive dental imagery prior to the appointment may reduce anxiety levels, promoting a more positive dental experience for pediatric patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

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

Study Start

First participant enrolled

October 25, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

April 29, 2025

Last Update Submit

May 13, 2025

Conditions

Keywords

dental anxietypediatric dentistry

Outcome Measures

Primary Outcomes (1)

  • Anxiety Level (Venham Picture Test - VPT)

    The primary outcome of this study is to evaluate the level of dental anxiety before and after the dental procedure.

    Day 1 (before and after the dental procedure)

Study Arms (2)

Positive Imagery Group

EXPERIMENTAL

Participants were exposed to positive images related to dental care (e.g., smiling children after treatment, positive interactions with the dentist) for 2 minutes prior to the dental procedure.

Behavioral: Positive Dental Imagery

Neutral imagery group

PLACEBO COMPARATOR

Participants were exposed to neutral images (nature scenes) for 2 minutes prior to the dental procedure.

Behavioral: Neutral Nature Imagery

Interventions

Children were shown four A4-sized laminated color images depicting positive dental scenes (e.g., children interacting happily with the dentist, smiling after treatment) for 2 minutes prior to the procedure.

Positive Imagery Group

Children were shown four A4-sized laminated color images depicting neutral nature scenes (e.g., a beach, sunset, flowers) for 2 minutes prior to the procedure.

Neutral imagery group

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children aged 5-13 years who were admitted to the Paediatric Dentistry Clinic of the Federal University of Rio Grande do Norte, and who required local anaesthesia during dental treatment

You may not qualify if:

  • Children with intellectual disabilities, visual or hearing impairments and children requiring emergency treatment were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio Grande do Norte - Departamento de odontologia

Natal, Rio Grande do Norte, 59052-000, Brazil

Location

Related Publications (1)

  • Kamel DO, Wahba NA, Talaat DM. Comparison between Positive Dental Images and Neutral Images in Managing Anticipatory Anxiety of Children. J Clin Pediatr Dent. 2017;41(2):116-119. doi: 10.17796/1053-4628-41.2.116.

    PMID: 28288299BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 13, 2025

Study Start

October 25, 2023

Primary Completion

July 29, 2024

Study Completion

December 17, 2024

Last Updated

May 18, 2025

Record last verified: 2025-05

Locations