Dental AnxietyNCT06058533
Pre-Visit Positive Imagery in Reducing Dental Anxiety
A study testing Previsit Imagery Picturebook in people with Dental Anxiety, run by University of Southern California at 1 site in United States.
Trial summary
The purpose of this study is to determine whether pre-visit positive imagery has an impact in decreasing dental anxiety and fear in pediatric patients as well as increasing patient cooperation during treatment visits. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Previsit Imagery Picturebook
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2023to 30 Jun 2025
- 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 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients that are healthy with no systemic conditions and are considered ASA I or ASA II
- Patients who have never had any form of dental treatment before.
- Patients who need at least 1 filling to be restored with composite due to caries and will need local anesthetic and nitrous oxide inhalation.
- English speaking patients
Who cannot join
- Patients with a visual impairment
- Patients with developmental delays that are unable to read or interpret pictures for their age-level.
- Patients whose treatment changes to something other than composite
- Patients who refuse to wear nitrous hood.
- Patients who are unable to read and comprehend English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Herman Ostrow School of Dentistry of USC
Los Angeles, California, 90089
About this study
Official title: The Effectiveness of Pre-Visit Positive Imagery in Reducing Dental Anxiety
The purpose of this study is to determine whether pre-visit positive imagery has an impact in decreasing dental anxiety and fear in pediatric patients as well as increasing patient cooperation during treatment visits. Patients needing at least 1 composite filling with nitrous and local anesthetic will receive a picture book if they are selected in the experimental group, and no picture book if they are in the control group. Patients will be asked to be fill out a pre-operative survey and post-operative survey asking how they feel about treatment. Parents will also be asked to fill out a post-operative survey.
Read the detailed description
This study is a prospective randomized control trial. The study will be conducted at the Herman Ostrow School of Dentistry Pediatric Dental Clinic and Healthy Smiles for Kids of Orange County clinic. Established patients of record that are 4-10 years old who meet the inclusion criteria will qualify.
Participants will be randomly assigned to two groups by flipping a coin and having pre-assigned envelopes in numeric order for each participant. The envelopes will be made ahead of time with heads representing Group 1 and tails representing Group 2. The envelopes will then be numbered and stored in a folder; once a participant consents to enroll in the study, the envelope will be drawn in numeric order determining the participants group number to ensure it is randomized, Group 1 will include patients receiving positive pre-visit imagery. Group 2 will be the control group and will not receive any form of positive pre-visit imagery. The positive pre-visit imagery group 1 will receive a picture book explaining their dental treatment appointment with pictures and some words. The picture book will be a hard copy and will be shown to them by a faculty advisor at USC and by the PI at Healthy Smiles for Kids. The patient's behavior will initially be assessed at their new patient or recall appointment based off the Frankl behavior scale. At the end of the treatment visit, patient behavior will be measured by the dental provider using the Frankl behavior scale. The dentists rating the behavior will be calibrated to ensure there is consistency in the Frankl scale rating and criteria for each score.
Patients will also be asked to fill out a pre- and post-survey that allows them to express their level of dental fear and anxiety before and after the appointment using the Venham Picture Test. The total time commitment will be about 20 minutes and will be a part of their normal dental visit, no additional time is needed. Parents/caregivers will also be given a post-operative survey asking whether they felt the pre-visit positive imagery helped improve patient's behavior.
- Conditions
- Dental Anxiety
- Being tested
- Previsit Imagery Picturebook
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Previsit Imagery PicturebookOther
This picturebook will include pictures of the dental operatory and materials the patient can expect to see during their dental treatment appointment. The pictures included will be generalized pictures of a dental operatory and dental materials. The picture book will also include some words to describe what is happening during the appointment. It is important to note that pictures of the local anesthetic / needle will not be shown in the picture book but will be used during the appointment. The procedures described are standard protocol at both clinics. The traditional picture book shown will be a hard copy.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No intervention will be given to this group. Each treatment visit will move forward as routine. |
| Previsit Imagery Group | Experimental | This group will be given previsit imagery (picture book) before treatment visit. Receives: Other: Previsit Imagery Picturebook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Anxiety
Patients will also be asked to fill out a pre- and post-survey that allows them to express their level of dental fear and anxiety before and after the appointment using the Venham Picture Test. The total time commitment will be about 20 minutes and will be a part of their normal dental visit, no additional time is needed.
Measured: 1 day (1 hour during their dental visit)
Patient Behavior
Parents/caregivers will also be given a post-operative survey asking whether they felt the pre-visit positive imagery helped improve patient's behavior.
Measured: 1 day (1 hour during their dental visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start15 Oct 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Pham, University of Southern California
- Investigators
- Arusha Bhatia, Principal investigator, Herman Ostrow School of Dentistry of USC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058533
- Sponsor's protocol ID
- HS-23-00464
- Status last verified
- Jul 2025
- First submitted
- 15 Sep 2023
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Pre-Visit Positive Imagery in Reducing Dental Anxiety
- ClinicalTrials.gov ID
- NCT06058533
- Acronym / sponsor ID
- HS-23-00464
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 28 Sep 2023 (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.
The purpose of this study is to determine whether pre-visit positive imagery has an impact in decreasing dental anxiety and fear in pediatric patients as well as increasing patient cooperation during treatment visits. Patients needing at least 1 composite filling with nitrous and local anesthetic will receive a picture book if they are selected in the experimental group, and no picture book if they are in the control group. Patients will be asked to be fill out a pre-operative survey and post-operative survey asking how they feel about treatment. Parents will also be asked to fill out a post-operative survey.
Detailed description
This study is a prospective randomized control trial. The study will be conducted at the Herman Ostrow School of Dentistry Pediatric Dental Clinic and Healthy Smiles for Kids of Orange County clinic. Established patients of record that are 4-10 years old who meet the inclusion criteria will qualify.
Participants will be randomly assigned to two groups by flipping a coin and having pre-assigned envelopes in numeric order for each participant. The envelopes will be made ahead of time with heads representing Group 1 and tails representing Group 2. The envelopes will then be numbered and stored in a folder; once a participant consents to enroll in the study, the envelope will be drawn in numeric order determining the participants group number to ensure it is randomized, Group 1 will include patients receiving positive pre-visit imagery. Group 2 will be the control group and will not receive any form of positive pre-visit imagery. The positive pre-visit imagery group 1 will receive a picture book explaining their dental treatment appointment with pictures and some words. The picture book will be a hard copy and will be shown to them by a faculty advisor at USC and by the PI at Healthy Smiles for Kids. The patient's behavior will initially be assessed at their new patient or recall appointment based off the Frankl behavior scale. At the end of the treatment visit, patient behavior will be measured by the dental provider using the Frankl behavior scale. The dentists rating the behavior will be calibrated to ensure there is consistency in the Frankl scale rating and criteria for each score.
Patients will also be asked to fill out a pre- and post-survey that allows them to express their level of dental fear and anxiety before and after the appointment using the Venham Picture Test. The total time commitment will be about 20 minutes and will be a part of their normal dental visit, no additional time is needed. Parents/caregivers will also be given a post-operative survey asking whether they felt the pre-visit positive imagery helped improve patient's behavior.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No intervention will be given to this group. Each treatment visit will move forward as routine. |
| Previsit Imagery Group | Experimental | Other: Previsit Imagery PicturebookThis group will be given previsit imagery (picture book) before treatment visit. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients that are healthy with no systemic conditions and are considered ASA I or ASA II
- Patients who have never had any form of dental treatment before.
- Patients who need at least 1 filling to be restored with composite due to caries and will need local anesthetic and nitrous oxide inhalation.
- English speaking patients
Key exclusion criteria (5 listed)
- Patients with a visual impairment
- Patients with developmental delays that are unable to read or interpret pictures for their age-level.
- Patients whose treatment changes to something other than composite
- Patients who refuse to wear nitrous hood.
- Patients who are unable to read and comprehend English.
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 |
|---|---|---|
| Previsit Imagery PicturebookThis picturebook will include pictures of the dental operatory and materials the patient can expect to see during their dental treatment appointment. The pictures included will be generalized pictures of a dental operatory and dental materials. The picture book will also include some words to describe what is happening during the appointment. It is important to note that pictures of the local anesthetic / needle will not be shown in the picture book but will be used during the appointment. The procedures described are standard protocol at both clinics. The traditional picture book shown will be a hard copy. | Other | Previsit Imagery Group |
Primary outcome
Dental Anxiety
Time frame: 1 day (1 hour during their dental visit)
Patients will also be asked to fill out a pre- and post-survey that allows them to express their level of dental fear and anxiety before and after the appointment using the Venham Picture Test. The total time commitment will be about 20 minutes and will be a part of their normal dental visit, no additional time is needed.
Patient Behavior
Time frame: 1 day (1 hour during their dental visit)
Parents/caregivers will also be given a post-operative survey asking whether they felt the pre-visit positive imagery helped improve patient's behavior.
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 14 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Arusha Bhatia principal investigator
Herman Ostrow School of Dentistry of USC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Previsit Imagery Picturebook in people with Dental Anxiety, run by University of Southern California at 1 site in United States.
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 4 inclusion and 5 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 14 Jul 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 United States. 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. 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?
Dental Anxiety (time frame: 1 day (1 hour during their dental visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2025.