The Effectiveness of Audiovisual Distraction Behavior Guidance Technique in Children With Dental … (NCT04226651) | Clinical Trial Compass
CompletedNot Applicable
The Effectiveness of Audiovisual Distraction Behavior Guidance Technique in Children With Dental Anxiety
Turkey (Türkiye)70 participantsStarted 2019-03-11
Plain-language summary
This randomized, two-armed, placebo-controlled, cross-over, controlled trial aimed to evaluate the effect of virtual reality exposure therapy (VRET) on dental anxiety, pain, and behaviour among children undergoing dental treatment under local anaesthesia. The null hypotheses were as follows: VRET has no effect on reducing dental anxiety and dental pain scores of participants; and there is no difference between subjective and objective measure scores of dental anxiety and pain when VRET and attention palcebo-controlled (APC) groups are used to reduce anxiety in children undergoing dental treatment with local anaesthesia.
Who can participate
Age range
7 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Requiring restorative treatment for first mandibular permanent molar tooth with dentin caries in each mandibular quadrant with a bilateral inferior alveolar nerve block
* Co-operative ability
Exclusion Criteria:
* Systemic or mental illnesses
* Limited audiovisual capabilities
* Acute dental pain or trauma
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dental Anxiety
Timeframe: Time 0: a minute after sitting in the dental unit ; Time 1: 1 min before local anaesthesia; Time 2: 1 min after local anaesthesia; Time 3: 1 min before end of the treatment
2
Dental Anxiety
Timeframe: Visit 0: 5 min before first inclusion visit, Visit 1: 5 min before first dental treatment visit,Visit 2: 5 min before second dental treatment visit,