Effect of VR vs Screens on Children's Dental Anxiety, Pain and Behavior (NCT05157438) | Clinical Trial Compass
UnknownNot Applicable
Effect of VR vs Screens on Children's Dental Anxiety, Pain and Behavior
Egypt42 participantsStarted 2023-10-01
Plain-language summary
Virtual reality distraction is intended to reduce the pain experience by distracting the patient attention from the pain stimulating procedure. Then, it breaks the cycle of negative experiences by improving the dental experience. The study's aim is to compare the effect of virtual reality to the effect of screen programs on dental anxiety, pain and behavior at different time points among children undergoing dental treatment under local anesthesia. The null hypothesis assumes that virtual reality has no effect on reducing the children's pain or anxiety and there is no difference between virtual reality and screen programs in improving the children's behavior and dental experience. The study's design is a cross-over, split mouth trial in which each patient will have similar dental treatments on each side, but with different distraction techniques.
Who can participate
Age range
5 Years – 7 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:
* Children between 5-7 years old age.
* Both genders.
* First dental visit
* Positive and definitely positive behavior according to Frankel behavior scale.
* Two or more badly decayed primary maxillary first molars beyond repair and need to be extracted.
* Systemically and mentally healthy.
Exclusion Criteria:
* History of systemic or mental conditions.
* Special health care needs who require pharmacological management prior to dental treatment.
* Acute dental pain or trauma.
* Extremely uncooperative children who require being treated under general anesthesia, negative and definitely negative according to Frankel behavior scale
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
RMS Pictorial Scale: A scale to assess the change in dental anxiety through the dental procedure
Timeframe: The dental anxiety is measured during same single visit. There is no follow up and no specific time duration for the visit. Pre-operative anxiety: before administration of local anesthesia and Post-operative anxiety: after dental extraction.