Dental AnxietyNCT05157438
Effect of VR vs Screens on Children's Dental Anxiety, Pain and Behavior
A study testing virtual reality device and screen programs in people with Dental Anxiety, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- virtual reality device and screen programs
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Mar 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry Cairo University
Cairo
ola omar, professor, 23634965 ext. +202, dentmail@dentistry.cu.edu.eg
hala mohyeldin, professor, 23642938 ext. +202, pedo@dentistry.cu.edu.eg
About this study
Official title: Comparative Evaluation of The Effect of Virtual Reality and Screen Programs on Children's Dental Anxiety, Pain and Behavior: A Randomized Cross-Over Clinical Trial
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.
Read the detailed description
Most of dental procedures are accompanied by pain and discomfort which subsequently adversely affect the patient's cooperation and willingness to complete or undergo the procedures. This negative behavior compromises the efficiency and quality of the delivered dental treatment, to the extent that it may not be completed. Therefore, behavior management techniques have been introduced to the field of pediatric dentistry to effectively manage the child anxiety and improve the child's experience in dental office to establish a positive child-dentist relationship. The virtual reality (VR) is considered a behavior management technique as well as a distraction tool, as it modifies the child's attitude. Thus, it can be used in the dental practice to help the dentist to control the child during the treatment procedure. The study's design is a cross-over, split mouth trial in which the procedure is planned to be on three visits, as the following: baseline visit (v0) for diagnosis, examination and inclusion, first visit (v1) and second visit (v2) for treatment sessions. A follow up visit (v3) may be needed for younger patients who need space maintenance for the extraction site. allocated and randomized equally into two groups according to the intervention assigned in the first treatment session: Group I (virtual reality group) and Group II (screen program group). In both groups, children will be allowed to choose an animation or cartoon from a list pre-prepared by the investigator in order to watch a show of their own choice, to augment the effect of distraction. Both groups will be managed and operated by the same operator who is the research investigator. Treatments were completed in two separate sessions, two weeks apart as a washout period, to avoid any carry-over effect. Each patient will have two teeth extracted, one on each side, on two successive visits, with two weeks apart as a washout period. The required sample size was calculated using the IBMª SPSSª Sample Powerª version 3.0.1 (IBMª Corp., Armonk, NY, USA). Subjects will be recruited from the outpatient clinic in Pediatric Dentistry and Dental Public health Department. Faculty of Dentistry, Cairo University, Egypt. Patients will be screened by the research investigator until the target population is achieved. The outcome data and results will be independently collected from each participant by the researcher, examined, organized and analyzed under the supervision of the assistant supervisor. Any missing data will be revised and handled with the best techniques according to the type of data missed. All data will be entered and stored on a secured personal computer in coded and password locked files. Backup of data on an external hard disc in order to prevent any data loss. Results will be statistically analyzed by using statistical package of social sciences (SPSS 26.0, IBM/SPSS Inc., Chicago, IL). There are two types of statistical methods Descriptive statistics and Analytical or inferential statistics. In this study, no data monitoring committee will be needed since it is a study with known minimal risks. The Main Supervisor will monitor this study. Auditing will be done by the main and co-supervisors to assure quality of the research methods, restorative technique and interventions.
- Conditions
- Dental Anxiety
- Being tested
- virtual reality device, screen programs
- Keywords
- virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality deviceBehavioural
The virtual reality device is a 3D head-mounted display which provides a wide field of view and a high-resolution visual display, it has been used to manage cases of phobia and extreme fear through the use of exposure-based treatment programs. The virtual reality system consists of head mounted glasses, a compatible smartphone and headphones. This technology creates a computer stimulated virtual environment into which the child can be entirely immersed. It works to distract the brain from the painful procedure and reduce the perception of pain stimuli
screen programsBehavioural
Also called tablets, televisions
the screens are used for distraction during dental treatments. they could be on tablets, iPads or televisions.
| Study group | Role | What they receive |
|---|---|---|
| Group I (virtual reality group) | Experimental | The virtual reality device is a 3D head-mounted display which provides a wide field of view and a high-resolution visual display, the system consists of head mounted glasses, a compatible smartphone and headphones. This technology creates a computer stimulated virtual environment. Receives: Behavioral: virtual reality device |
| Group II (screen program group). | Active comparator | the screens shows such as cartoons, animation movies or recorded video games are used for distraction during dental treatments. They could be seen on tablets, iPads or LCD screen. Receives: Behavioral: screen programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
RMS Pictorial Scale: A scale to assess the change in dental anxiety through the dental procedure
The scale consists of row of 5 photographs of a child showing 5 different faces ranging from happy to very unhappy. The child is asked to choose the face that looks like what they feel at the moment. The score is recorded by giving value of 1 to happy and value of 5 to very unhappy. The RMS-pictorial scale is chosen for simple and easy for the child to understand, has 2 sets of photographs for boys and for girls, which gives efficient evaluation of dental anxiety.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start1 Oct 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Salem Yousry Mahrouse, Cairo University
- Investigators
- Amal S Abdelatty, Masters, Principal investigator, Cairo UniversityCairo University, Study chair, 11 El-Saraya St. - Manial - Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157438
- Sponsor's protocol ID
- VR in Child Anxiety
- Status last verified
- Nov 2023
- First submitted
- 11 Nov 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nunna M, Dasaraju RK, Kamatham R, Mallineni SK, Nuvvula S. Comparative evaluation of virtual reality distraction and counter-stimulation on dental anxiety and pain perception in children. J Dent Anesth Pain Med. 2019 Oct;19(5):277-288. doi: 10.17245/jdapm.2019.19.5.277. Epub 2019 Oct 30.
PubMed 31723668Rao DG, Havale R, Nagaraj M, Karobari NM, Latha AM, Tharay N, Shrutha SP. Assessment of Efficacy of Virtual Reality Distraction in Reducing Pain Perception and Anxiety in Children Aged 6-10 Years: A Behavioral Interventional Study. Int J Clin Pediatr Dent. 2019 Nov-Dec;12(6):510-513. doi: 10.5005/jp-journals-10005-1694.
PubMed 32440065Tanja-Dijkstra K, Pahl S, White MP, Andrade J, Qian C, Bruce M, May J, Moles DR. Improving dental experiences by using virtual reality distraction: a simulation study. PLoS One. 2014 Mar 12;9(3):e91276. doi: 10.1371/journal.pone.0091276. eCollection 2014.
PubMed 24621518Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12.
PubMed 23277857Nuvvula S, Alahari S, Kamatham R, Challa RR. Effect of audiovisual distraction with 3D video glasses on dental anxiety of children experiencing administration of local analgesia: a randomised clinical trial. Eur Arch Paediatr Dent. 2015 Feb;16(1):43-50. doi: 10.1007/s40368-014-0145-9. Epub 2014 Sep 26.
PubMed 25256207Niharika P, Reddy NV, Srujana P, Srikanth K, Daneswari V, Geetha KS. Effects of distraction using virtual reality technology on pain perception and anxiety levels in children during pulp therapy of primary molars. J Indian Soc Pedod Prev Dent. 2018 Oct-Dec;36(4):364-369. doi: 10.4103/JISPPD.JISPPD_1158_17.
PubMed 30324926
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of The Effect of Virtual Reality and Screen Programs on Children's Dental Anxiety, Pain and Behavior: A Randomized Cross-Over Clinical Trial
- ClinicalTrials.gov ID
- NCT05157438
- Acronym / sponsor ID
- VR in Child Anxiety
- Conditions
- Dental Anxiety
- Keywords
- virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 15 Dec 2021 (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.
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.
Detailed description
Most of dental procedures are accompanied by pain and discomfort which subsequently adversely affect the patient's cooperation and willingness to complete or undergo the procedures. This negative behavior compromises the efficiency and quality of the delivered dental treatment, to the extent that it may not be completed. Therefore, behavior management techniques have been introduced to the field of pediatric dentistry to effectively manage the child anxiety and improve the child's experience in dental office to establish a positive child-dentist relationship. The virtual reality (VR) is considered a behavior management technique as well as a distraction tool, as it modifies the child's attitude. Thus, it can be used in the dental practice to help the dentist to control the child during the treatment procedure. The study's design is a cross-over, split mouth trial in which the procedure is planned to be on three visits, as the following: baseline visit (v0) for diagnosis, examination and inclusion, first visit (v1) and second visit (v2) for treatment sessions. A follow up visit (v3) may be needed for younger patients who need space maintenance for the extraction site. allocated and randomized equally into two groups according to the intervention assigned in the first treatment session: Group I (virtual reality group) and Group II (screen program group). In both groups, children will be allowed to choose an animation or cartoon from a list pre-prepared by the investigator in order to watch a show of their own choice, to augment the effect of distraction. Both groups will be managed and operated by the same operator who is the research investigator. Treatments were completed in two separate sessions, two weeks apart as a washout period, to avoid any carry-over effect. Each patient will have two teeth extracted, one on each side, on two successive visits, with two weeks apart as a washout period. The required sample size was calculated using the IBMª SPSSª Sample Powerª version 3.0.1 (IBMª Corp., Armonk, NY, USA). Subjects will be recruited from the outpatient clinic in Pediatric Dentistry and Dental Public health Department. Faculty of Dentistry, Cairo University, Egypt. Patients will be screened by the research investigator until the target population is achieved. The outcome data and results will be independently collected from each participant by the researcher, examined, organized and analyzed under the supervision of the assistant supervisor. Any missing data will be revised and handled with the best techniques according to the type of data missed. All data will be entered and stored on a secured personal computer in coded and password locked files. Backup of data on an external hard disc in order to prevent any data loss. Results will be statistically analyzed by using statistical package of social sciences (SPSS 26.0, IBM/SPSS Inc., Chicago, IL). There are two types of statistical methods Descriptive statistics and Analytical or inferential statistics. In this study, no data monitoring committee will be needed since it is a study with known minimal risks. The Main Supervisor will monitor this study. Auditing will be done by the main and co-supervisors to assure quality of the research methods, restorative technique and interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (virtual reality group) | Experimental | Behavioral: virtual reality deviceThe virtual reality device is a 3D head-mounted display which provides a wide field of view and a high-resolution visual display, the system consists of head mounted glasses, a compatible smartphone and headphones. This technology creates a computer stimulated virtual environment. |
| Group II (screen program group). | Active comparator | Behavioral: screen programsthe screens shows such as cartoons, animation movies or recorded video games are used for distraction during dental treatments. They could be seen on tablets, iPads or LCD screen. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 deviceThe virtual reality device is a 3D head-mounted display which provides a wide field of view and a high-resolution visual display, it has been used to manage cases of phobia and extreme fear through the use of exposure-based treatment programs. The virtual reality system consists of head mounted glasses, a compatible smartphone and headphones. This technology creates a computer stimulated virtual environment into which the child can be entirely immersed. It works to distract the brain from the painful procedure and reduce the perception of pain stimuli | Behavioural | Group I (virtual reality group) |
| screen programsAlso: tablets, televisionsthe screens are used for distraction during dental treatments. they could be on tablets, iPads or televisions. | Behavioural | Group II (screen program group). |
Primary outcome
RMS Pictorial Scale: A scale to assess the change in dental anxiety through the dental procedure
Time frame: 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.
The scale consists of row of 5 photographs of a child showing 5 different faces ranging from happy to very unhappy. The child is asked to choose the face that looks like what they feel at the moment. The score is recorded by giving value of 1 to happy and value of 5 to very unhappy. The RMS-pictorial scale is chosen for simple and easy for the child to understand, has 2 sets of photographs for boys and for girls, which gives efficient evaluation of dental anxiety.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 31723668Nunna M, Dasaraju RK, Kamatham R, Mallineni SK, Nuvvula S. Comparative evaluation of virtual reality distraction and counter-stimulation on dental anxiety and pain perception in children. J Dent Anesth Pain Med. 2019 Oct;19(5):277-288. doi: 10.17245/jdapm.2019.19.5.277. Epub 2019 Oct 30.
- Background: PubMed 32440065Rao DG, Havale R, Nagaraj M, Karobari NM, Latha AM, Tharay N, Shrutha SP. Assessment of Efficacy of Virtual Reality Distraction in Reducing Pain Perception and Anxiety in Children Aged 6-10 Years: A Behavioral Interventional Study. Int J Clin Pediatr Dent. 2019 Nov-Dec;12(6):510-513. doi: 10.5005/jp-journals-10005-1694.
- Background: PubMed 24621518Tanja-Dijkstra K, Pahl S, White MP, Andrade J, Qian C, Bruce M, May J, Moles DR. Improving dental experiences by using virtual reality distraction: a simulation study. PLoS One. 2014 Mar 12;9(3):e91276. doi: 10.1371/journal.pone.0091276. eCollection 2014.
- Background: PubMed 23277857Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12.
- Background: PubMed 25256207Nuvvula S, Alahari S, Kamatham R, Challa RR. Effect of audiovisual distraction with 3D video glasses on dental anxiety of children experiencing administration of local analgesia: a randomised clinical trial. Eur Arch Paediatr Dent. 2015 Feb;16(1):43-50. doi: 10.1007/s40368-014-0145-9. Epub 2014 Sep 26.
- Background: PubMed 30324926Niharika P, Reddy NV, Srujana P, Srikanth K, Daneswari V, Geetha KS. Effects of distraction using virtual reality technology on pain perception and anxiety levels in children during pulp therapy of primary molars. J Indian Soc Pedod Prev Dent. 2018 Oct-Dec;36(4):364-369. doi: 10.4103/JISPPD.JISPPD_1158_17.
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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.
Amal S Abdelatty, Masters principal investigator
Cairo University
Cairo University study chair
11 El-Saraya St. - Manial - Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality device and screen programs in people with Dental Anxiety, run by Cairo 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 6 inclusion and 4 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 18 Nov 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amal S Abdelatty (+201092623145, amal.mahrouse@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RMS Pictorial Scale: A scale to assess the change in dental anxiety through the dental procedure (time frame: 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.). 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 NCT05157438, which also lists 6 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 18 Nov 2023.