Virtual RealityPhase 4NCT06355492
Virtual Reality Distraction in Pediatric Patients.
A Phase 4 study testing Virtual reality goggles (VR ) and regular screen in people with Virtual Reality and Distraction, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Virtual Reality, Distraction, Infiltration Anesthesia
- What is being tested?
- Virtual reality goggles (VR ) and regular screen
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to Jul 2025
- Phase
- Phase 4
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children with no systemic illness.
- Cooperative child with frankels behavior rating scale positive or definitely positive.
- Patient requiring infiltration LA for dental treatment.
- Children with proper parental consent.
- Patients who needed non-urgent dental treatment.
Who cannot join
- Medical disability such as history of seizures, convulsion disorder, vertigo, eye problems and autism.
- Children below 5 years of age.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Rokia Abdelrhman Saad Elfaramawy
Tanta, El-Gharbia, 31527
Rokia A Elfaramawy, BDS, 01069823221, Rokiaabdelrahman94@gmail.com
Fatma A Elhendawy, Professor
About this study
Official title: Effectiveness of Virtual Reality Distraction During Infiltration Anesthesia in Pediatric Patients.
The aim of this study is to evaluate the effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients.
Read the detailed description
Proper pain control and discomfort reduction during dental treatment, especially among children, can maximize a child's cooperation, overall satisfaction, build a good dentist-patient relationship, and enhance patient compliance. Psychological and pharmaceutical methods, and their combinations have tried to address this pain. Pharmaceutical approaches include the application of topical anesthetics. Psychological and behavioral modification methods including active distractions, deep breathing, Witaul and eye movement distractions. Passive distraction methods, such as audiovisual glasses and video distraction. Other methods, such as precooling the injection site, warming the local anesthesia, and camouflaging the syringe, have also been suggested.
A range of fear management techniques have been described in the literature and American Academy of Pediatric Dentistry (AAPD) has described some concepts as basic behavior guidance such as communication, tell show do, voice control, nonverbal communication, positive reinforcement, distraction and parental absence/presence, and advanced behavior guidance such as protective stabilization, sedation and general anesthesia.
Distraction as a behavior guidance technique is defined by the American Academy of Pediatric Dentistry (AAPD) as the technique of diverting the patient's attention from what may be perceived as an unpleasant procedure.
Audiovisual distraction techniques are used in dental clinics and have shown great results in managing anxious pediatric patients.
Virtual reality (VR) distraction, defined as a human-computer interface that enables the user to interact dynamically with the computer- generated environment is a new method in the medical field with the aim of aiding in patient behavior management. It offers the advantage of an immersive virtual experience blocking out external stimuli that may provoke a negative attitude, especially in young patients.
Distraction using VR provided favorable outcomes for adult and pediatric patients during various dental procedures, ranging from simple anesthesia to periodontal, restorative, and pulpal therapy .
- Being tested
- Virtual reality goggles (VR ), regular screen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality goggles (VR )Device
Patients will take buccal infiltration anaethesia using (Virtual reality goggles) that properly adjusted around the patient's head and in front of his/her eyes.
regular screenDevice
Patients will take buccal infiltration anaethesia using (regular screen ).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Patients will take buccal infiltration anesthesia using (regular screen). Receives: Device: regular screen |
| VR group | Experimental | Patients will take buccal infiltration anesthesia using (Virtual reality goggles). Receives: Device: Virtual reality goggles (VR ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain during virtual reality distraction
During local anesthesia administration, the face, legs, activity, cry, consolability (FLACC) behavioral pain assessment scale (objective scale) will be recorded to assess pain. Immediately after anesthetic administration, the patients will be placed in upright position and will be shown Wong-Baker faces pain rating scale (subjective scale) and give a brief explanation to the child about each face and instruct the child to choose the face that describe their feeling during administration of local anaethesia
Measured: After 2 weeks from the first visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rokia Abdelrhman Saad Elfaramawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355492
- Sponsor's protocol ID
- 2090/10/30
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kamath PS. A novel distraction technique for pain management during local anesthesia administration in pediatric patients. J Clin Pediatr Dent. 2013 Fall;38(1):45-7. doi: 10.17796/jcpd.38.1.265807t236570hx7.
PubMed 24579282Custodio NB, Costa FDS, Cademartori MG, da Costa VPP, Goettems ML. Effectiveness of Virtual Reality Glasses as a Distraction for Children During Dental Care. Pediatr Dent. 2020 Mar 15;42(2):93-102.
PubMed 32276674Al-Khotani A, Bello LA, Christidis N. Effects of audiovisual distraction on children's behaviour during dental treatment: a randomized controlled clinical trial. Acta Odontol Scand. 2016 Aug;74(6):494-501. doi: 10.1080/00016357.2016.1206211. Epub 2016 Jul 13.
PubMed 27409593
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality Distraction During Infiltration Anesthesia in Pediatric Patients.
- ClinicalTrials.gov ID
- NCT06355492
- Acronym / sponsor ID
- 2090/10/30
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 9 Apr 2024 (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 aim of this study is to evaluate the effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients.
Detailed description
Proper pain control and discomfort reduction during dental treatment, especially among children, can maximize a child's cooperation, overall satisfaction, build a good dentist-patient relationship, and enhance patient compliance. Psychological and pharmaceutical methods, and their combinations have tried to address this pain. Pharmaceutical approaches include the application of topical anesthetics. Psychological and behavioral modification methods including active distractions, deep breathing, Witaul and eye movement distractions. Passive distraction methods, such as audiovisual glasses and video distraction. Other methods, such as precooling the injection site, warming the local anesthesia, and camouflaging the syringe, have also been suggested.
A range of fear management techniques have been described in the literature and American Academy of Pediatric Dentistry (AAPD) has described some concepts as basic behavior guidance such as communication, tell show do, voice control, nonverbal communication, positive reinforcement, distraction and parental absence/presence, and advanced behavior guidance such as protective stabilization, sedation and general anesthesia.
Distraction as a behavior guidance technique is defined by the American Academy of Pediatric Dentistry (AAPD) as the technique of diverting the patient's attention from what may be perceived as an unpleasant procedure.
Audiovisual distraction techniques are used in dental clinics and have shown great results in managing anxious pediatric patients.
Virtual reality (VR) distraction, defined as a human-computer interface that enables the user to interact dynamically with the computer- generated environment is a new method in the medical field with the aim of aiding in patient behavior management. It offers the advantage of an immersive virtual experience blocking out external stimuli that may provoke a negative attitude, especially in young patients.
Distraction using VR provided favorable outcomes for adult and pediatric patients during various dental procedures, ranging from simple anesthesia to periodontal, restorative, and pulpal therapy .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Device: regular screenPatients will take buccal infiltration anesthesia using (regular screen). |
| VR group | Experimental | Device: Virtual reality goggles (VR )Patients will take buccal infiltration anesthesia using (Virtual reality goggles). |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children with no systemic illness.
- Cooperative child with frankels behavior rating scale positive or definitely positive.
- Patient requiring infiltration LA for dental treatment.
- Children with proper parental consent.
- Patients who needed non-urgent dental treatment.
Key exclusion criteria (2 listed)
- Medical disability such as history of seizures, convulsion disorder, vertigo, eye problems and autism.
- Children below 5 years of age.
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 |
|---|---|---|
| Virtual reality goggles (VR )Patients will take buccal infiltration anaethesia using (Virtual reality goggles) that properly adjusted around the patient's head and in front of his/her eyes. | Device | VR group |
| regular screenPatients will take buccal infiltration anaethesia using (regular screen ). | Device | Control group |
Primary outcome
Assessment of pain during virtual reality distraction
Time frame: After 2 weeks from the first visit.
During local anesthesia administration, the face, legs, activity, cry, consolability (FLACC) behavioral pain assessment scale (objective scale) will be recorded to assess pain. Immediately after anesthetic administration, the patients will be placed in upright position and will be shown Wong-Baker faces pain rating scale (subjective scale) and give a brief explanation to the child about each face and instruct the child to choose the face that describe their feeling during administration of local anaethesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Background: PubMed 24579282Kamath PS. A novel distraction technique for pain management during local anesthesia administration in pediatric patients. J Clin Pediatr Dent. 2013 Fall;38(1):45-7. doi: 10.17796/jcpd.38.1.265807t236570hx7.
- Background: PubMed 32276674Custodio NB, Costa FDS, Cademartori MG, da Costa VPP, Goettems ML. Effectiveness of Virtual Reality Glasses as a Distraction for Children During Dental Care. Pediatr Dent. 2020 Mar 15;42(2):93-102.
- Background: PubMed 27409593Al-Khotani A, Bello LA, Christidis N. Effects of audiovisual distraction on children's behaviour during dental treatment: a randomized controlled clinical trial. Acta Odontol Scand. 2016 Aug;74(6):494-501. doi: 10.1080/00016357.2016.1206211. Epub 2016 Jul 13.
Related trials for Virtual Reality
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
Not yet recruiting
Testing the Timing and Application of Virtual Reality Distraction During Knee Injections in a VA Pain Clinic
Pain Management, Injection Pain Prevention
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
Not yet recruiting
Evidence-based, Customized, Motion-recognition Rehabilitation System Development for Bed-ridden Patients - Validation of Effectiveness: Rehabit: Swim
ICU-acquired Weakness
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Virtual reality goggles (VR ) and regular screen in people with Virtual Reality and Distraction, run by Tanta University at 1 site in Egypt.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Apr 2024. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain during virtual reality distraction (time frame: After 2 weeks from the first visit.). 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 NCT06355492, which also lists 3 linked publications.
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 9 Apr 2024.