Dental AnxietyNCT06966726
Positive Pre-Visit Imagery Does Not Reduce Dental Anxiety in Children
A study testing Positive Dental Imagery and Neutral Nature Imagery in people with Dental Anxiety and Dental Fear and Anxiety, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Dental Fear and Anxiety
- What is being tested?
- Positive Dental Imagery and Neutral Nature Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Oct 2023to 17 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Children with intellectual disabilities, visual or hearing impairments and children requiring emergency treatment were excluded
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Norte - Departamento de odontologia
Natal, Rio Grande do Norte, 59052-000
About this study
Official title: Positive Pre-Visit Imagery Does Not Reduce Dental Anxiety in Children: A Randomized, Triple-Blind, Controlled Trial
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.
Read the detailed description
Dental anxiety (DA) is a significant barrier to dental care in children and is commonly associated with negative treatment experiences, particularly during procedures such as local anaesthesia. Children with DA are more likely to exhibit poor oral health outcomes and reduced quality of life. Behaviour management techniques (BMTs), such as distraction, tell-show-do, desensitization, and positive reinforcement, are routinely used in pediatric dentistry to help reduce anxiety and improve cooperation.
Among the newer BMTs, positive pre-visit imagery-where children view positive dental-related images prior to treatment-has shown promise. This technique is based on observational learning and aims to create positive associations with dental care. However, current evidence is limited and inconclusive.
This triple-blind randomized controlled trial investigates the effectiveness of positive pre-visit imagery in reducing DA in children. Sixty-nine children aged 5 to 13 years requiring local anaesthesia were randomly assigned to view either a series of positive dental images (intervention group) or neutral nature scenes (control group) prior to treatment. The intervention consisted of four A4 laminated images designed to elicit positive emotional responses related to dental care, while the control group viewed four neutral nature photographs.
Anxiety was assessed before and after the dental procedure using the Venham Picture Test (VPT), a validated tool for evaluating dental anxiety in children. The primary outcome was the change in anxiety level between pre- and post-treatment, and the data were analyzed using non-parametric statistical methods.
The study follows CONSORT guidelines and was approved by the Human Research Ethics Committee at the Federal University of Rio Grande do Norte. This trial aims to provide robust evidence regarding the effectiveness of positive pre-visit imagery as a non-pharmacological strategy for managing dental anxiety in children.
- Conditions
- Dental Anxiety, Dental Fear and Anxiety
- Being tested
- Positive Dental Imagery, Neutral Nature Imagery
- Keywords
- dental anxiety, pediatric dentistry
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Dental ImageryBehavioural
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.
Neutral Nature ImageryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Neutral Nature Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (before and after the dental procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start25 Oct 2023
- Primary completion29 Jul 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lavínia Lourenço Costa, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966726
- Sponsor's protocol ID
- 71431923.0.0000.5537
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28288299
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Pre-Visit Imagery Does Not Reduce Dental Anxiety in Children: A Randomized, Triple-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT06966726
- Acronym / sponsor ID
- 71431923.0.0000.5537
- Conditions
- Dental Anxiety, Dental Fear and Anxiety
- Keywords
- dental anxiety, pediatric dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dental anxiety (DA) is a significant barrier to dental care in children and is commonly associated with negative treatment experiences, particularly during procedures such as local anaesthesia. Children with DA are more likely to exhibit poor oral health outcomes and reduced quality of life. Behaviour management techniques (BMTs), such as distraction, tell-show-do, desensitization, and positive reinforcement, are routinely used in pediatric dentistry to help reduce anxiety and improve cooperation.
Among the newer BMTs, positive pre-visit imagery-where children view positive dental-related images prior to treatment-has shown promise. This technique is based on observational learning and aims to create positive associations with dental care. However, current evidence is limited and inconclusive.
This triple-blind randomized controlled trial investigates the effectiveness of positive pre-visit imagery in reducing DA in children. Sixty-nine children aged 5 to 13 years requiring local anaesthesia were randomly assigned to view either a series of positive dental images (intervention group) or neutral nature scenes (control group) prior to treatment. The intervention consisted of four A4 laminated images designed to elicit positive emotional responses related to dental care, while the control group viewed four neutral nature photographs.
Anxiety was assessed before and after the dental procedure using the Venham Picture Test (VPT), a validated tool for evaluating dental anxiety in children. The primary outcome was the change in anxiety level between pre- and post-treatment, and the data were analyzed using non-parametric statistical methods.
The study follows CONSORT guidelines and was approved by the Human Research Ethics Committee at the Federal University of Rio Grande do Norte. This trial aims to provide robust evidence regarding the effectiveness of positive pre-visit imagery as a non-pharmacological strategy for managing dental anxiety in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Imagery Group | Experimental | Behavioral: Positive Dental ImageryParticipants 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. |
| Neutral imagery group | Placebo comparator | Behavioral: Neutral Nature ImageryParticipants were exposed to neutral images (nature scenes) for 2 minutes prior to the dental procedure. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Children with intellectual disabilities, visual or hearing impairments and children requiring emergency treatment were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Dental ImageryChildren 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. | Behavioural | Positive Imagery Group |
| Neutral Nature ImageryChildren 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. | Behavioural | Neutral imagery group |
Primary outcome
Anxiety Level (Venham Picture Test - VPT)
Time frame: Day 1 (before and after the dental procedure)
The primary outcome of this study is to evaluate the level of dental anxiety before and after the dental procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Background: PubMed 28288299Kamel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Dental Imagery and Neutral Nature Imagery in people with Dental Anxiety and Dental Fear and Anxiety, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Level (Venham Picture Test - VPT) (time frame: Day 1 (before and after the dental procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06966726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.