Dental AnxietyNCT05854329
The Effects of Preoperative Immersive and Non-Immersive Virtual Reality Exposure on Dental Anxiety in Children:A Randomised Controlled Trial
A study testing Virtual Reality Exposure in people with Dental Anxiety, run by University of Malaya at 1 site in Malaysia.
Trial summary
The goal of this randomised controlled trial is to compare the effects of Immersive Virtual Reality(IVRE) and Non-Immersive Virtual Reality(NIVRE) andin children having dental anxiety.The main question[s] it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Virtual Reality Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteMalaysia
- Study dates
- 23 May 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 9-12 years old.
- Children who can understand and complete the Malay-MCDASf questionnaire with a score of 19 and above.
- Children who requires fissure sealants on sound permanent tooth.
Who cannot join
- Children requiring emergency dental treatment for pain, trauma or facial cellulitis.
- Children that have undergone invasive dental treatment such as extraction and pulp therapy in the past 6 months.
- Children with hearing or visual impairment, developmental or intellectual disability, cognitive impairment, balance disorders such as vertigo and cybersickness, sensitivity to the motion or flash light, having accident in the eye, face, neck or arms, history of epileptic seizures, history of cardiac problems
- Parents who refuse to allow their children to participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Preoperative Immersive and Non-Immersive Virtual Reality Exposure on Dental Anxiety in Children: a Randomised Controlled Trial
The goal of this randomised controlled trial is to compare the effects of Immersive Virtual Reality(IVRE) and Non-Immersive Virtual Reality(NIVRE) andin children having dental anxiety.The main question[s] it aims to answer are:
- Is there a significant difference in baseline dental anxiety scores, as measured using the Malay-MCDASf and PR across the IVRE, NIVRE, and control groups?
- What is the mean change score in dental anxiety measured using the Malay-MCDASf and PR for IVRE, NIVRE, and control groups after the operative procedure?
- Is there a significant difference in mean change score of dental anxiety measured using the Malay-MCDASf and PR across the IVRE, NIVRE, and control groups?
- Is there a significant correlation between the Malay-MCDASf scores (subjective) and PR scores (objective) at preoperative, postoperative, and using the score changes for all groups?
Read the detailed description
Participants will be randomised into three groups, Immersive Virtual Reality, Non Immersive Virtual Reality and Control Group.Immersive Virtual Reality group will be asked to play with an immersive virtual reality dental game using Virtual reality device preoperatively after which they will undergo treatment. For the Non Immersive Virtual Reality participants will be asked to watch a dental cartoon using the virtual reality device passively before treatment and the control group of no intervention, to wait as usual before treatment. All groups will undergo dental treatment of resin based fissure sealant placement under cotton roll isolation in one permanent molar.
- Conditions
- Dental Anxiety
- Being tested
- Virtual Reality Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality ExposureBehavioural
Virtual Reality device using the immersive dental game.
| Study group | Role | What they receive |
|---|---|---|
| Immersive Virtual Reality Exposure | Experimental | Immersive Virtual Reality Dental Game for 15 minutes. Participants will be actively involved with the game, in placing restorations, scaling virtually playing the role of the dentist. Receives: Behavioral: Virtual Reality Exposure |
| Non-Immersive Virtual Reality Exposure | Active comparator | Participants will be made to watch dental related cartoon passively while sitting using the Virtual Reality device for 15 minutes. Receives: Behavioral: Virtual Reality Exposure |
| Control Group | No intervention | Participants will be waiting for 15 minutes as usual prior to their treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Malay-MCDASf score
Malay translated Modified Child Dental Anxiety Scale faces version
Measured: 10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same day
Secondary outcomes (1)
Change in Pulse Rate
Will be measured using Pulse Oximeter
Measured: 10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start23 May 2023
- Primary completion28 Jul 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 University of MalayaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Immersive and Non immersive Virtual Reality
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leezallini Selvaraj, Principal investigator, Faculty of Dentistry Medical Ethics Committee (FDMEC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854329
- Sponsor's protocol ID
- DF CD2313/0024 (P)
- Status last verified
- Jan 2025
- First submitted
- 21 Apr 2023
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Selvaraj L, Yusof ZYM, Zakaria NN, Azizi NZ, Aalam NZ. Effects of Preoperative Immersive and Non-Immersive Virtual Reality Exposure on Dental Anxiety in Children: A Randomised Controlled Trial. Int J Paediatr Dent. 2026 May;36(3):431-439. doi: 10.1111/ipd.70066. Epub 2025 Dec 22.
PubMed 41429659
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Preoperative Immersive and Non-Immersive Virtual Reality Exposure on Dental Anxiety in Children: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05854329
- Acronym / sponsor ID
- DF CD2313/0024 (P)
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 11 May 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 goal of this randomised controlled trial is to compare the effects of Immersive Virtual Reality(IVRE) and Non-Immersive Virtual Reality(NIVRE) andin children having dental anxiety.The main question[s] it aims to answer are:
- Is there a significant difference in baseline dental anxiety scores, as measured using the Malay-MCDASf and PR across the IVRE, NIVRE, and control groups?
- What is the mean change score in dental anxiety measured using the Malay-MCDASf and PR for IVRE, NIVRE, and control groups after the operative procedure?
- Is there a significant difference in mean change score of dental anxiety measured using the Malay-MCDASf and PR across the IVRE, NIVRE, and control groups?
- Is there a significant correlation between the Malay-MCDASf scores (subjective) and PR scores (objective) at preoperative, postoperative, and using the score changes for all groups?
Detailed description
Participants will be randomised into three groups, Immersive Virtual Reality, Non Immersive Virtual Reality and Control Group.Immersive Virtual Reality group will be asked to play with an immersive virtual reality dental game using Virtual reality device preoperatively after which they will undergo treatment. For the Non Immersive Virtual Reality participants will be asked to watch a dental cartoon using the virtual reality device passively before treatment and the control group of no intervention, to wait as usual before treatment. All groups will undergo dental treatment of resin based fissure sealant placement under cotton roll isolation in one permanent molar.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Immersive and Non immersive Virtual Reality
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality Exposure | Experimental | Behavioral: Virtual Reality ExposureImmersive Virtual Reality Dental Game for 15 minutes. Participants will be actively involved with the game, in placing restorations, scaling virtually playing the role of the dentist. |
| Non-Immersive Virtual Reality Exposure | Active comparator | Behavioral: Virtual Reality ExposureParticipants will be made to watch dental related cartoon passively while sitting using the Virtual Reality device for 15 minutes. |
| Control Group | No intervention | –Participants will be waiting for 15 minutes as usual prior to their treatment. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 9-12 years old.
- Children who can understand and complete the Malay-MCDASf questionnaire with a score of 19 and above.
- Children who requires fissure sealants on sound permanent tooth.
Key exclusion criteria (4 listed)
- Children requiring emergency dental treatment for pain, trauma or facial cellulitis.
- Children that have undergone invasive dental treatment such as extraction and pulp therapy in the past 6 months.
- Children with hearing or visual impairment, developmental or intellectual disability, cognitive impairment, balance disorders such as vertigo and cybersickness, sensitivity to the motion or flash light, having accident in the eye, face, neck or arms, history of epileptic seizures, history of cardiac problems
- Parents who refuse to allow their children to participate in the trial.
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 ExposureVirtual Reality device using the immersive dental game. | Behavioural | Immersive Virtual Reality Exposure, Non-Immersive Virtual Reality Exposure |
Primary outcome
Change in Malay-MCDASf score
Time frame: 10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same day
Malay translated Modified Child Dental Anxiety Scale faces version
1 secondary outcome
Change in Pulse Rate
Time frame: 10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same day
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 28 Jan 2025.
- Derived from this study: PubMed 41429659Selvaraj L, Yusof ZYM, Zakaria NN, Azizi NZ, Aalam NZ. Effects of Preoperative Immersive and Non-Immersive Virtual Reality Exposure on Dental Anxiety in Children: A Randomised Controlled Trial. Int J Paediatr Dent. 2026 May;36(3):431-439. doi: 10.1111/ipd.70066. Epub 2025 Dec 22.
- Individual participant dataSharing planned: No
Related trials for Dental Anxiety
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Recruiting
Pain Perception With Cordless Electronic Local Anesthetic Delivery System
Decayed Primary Molars
RecruitingObservational study
Bruxism, Anxiety, and Periodontal Status Among Dental Students
Bruxism, Anxiety
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Active, not recruiting
Musical Intervention for Dental Anxiety
Dental Anxiety
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.
Leezallini Selvaraj principal investigator
Faculty of Dentistry Medical Ethics Committee (FDMEC)
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 Exposure in people with Dental Anxiety, run by University of Malaya at 1 site in Malaysia.
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 3 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: finished, as of the sponsor's last update on 28 Jan 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 Malaysia. 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?
Change in Malay-MCDASf score (time frame: 10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same day). 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 NCT05854329, which also lists 1 linked publication.
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 28 Jan 2025.