A trial on the use of virtual reality in children during dental local anesthesia
| ISRCTN | ISRCTN42144944 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42144944 |
| Sponsor | Umm Al-Qura University |
| Funder | Umm Al-Qura University |
- Submission date
- 13/09/2026
- Registration date
- 11/10/2026
- Last edited
- 05/10/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Many children feel anxious or experience pain when receiving a local anaesthetic injection during dental treatment. Anxiety and pain can make dental visits more difficult for children, parents, and dental professionals. Virtual reality (VR) technology may help distract children during medical and dental procedures, reducing their discomfort and fear. This study aims to find out whether using a VR headset during a dental injection can reduce pain, anxiety, and distress in children compared with standard care.
Who can participate?
Children aged 4 to 10 years who are generally healthy, have not had dental treatment or visited a dental setting in the previous six months, and whose parent or guardian agrees to participation can take part.
What does the study involve?
After parents or guardians provide consent, participating children are randomly allocated to one of two groups. One group receives local anaesthetic injections while wearing a VR headset, while the other group receives the injection without VR. Before treatment, measurements are taken including pulse rate and behaviour scores. Additional measurements are recorded during and after the injection. Researchers assess anxiety using pulse oximeter readings, behaviour using validated behavioural scales, and pain using a child-friendly pain rating scale. The results from the two groups are compared to determine whether VR reduces anxiety, pain, and distress during dental injections.
What are the possible benefits and risks of participating?
Children using VR may experience less anxiety and discomfort during the dental procedure. The study may help identify effective ways to improve children's experiences of dental treatment in the future. Risks are expected to be minimal and are mainly related to the routine dental injection. Some children may find the VR headset uncomfortable or may not wish to use it.
Where is the study run from?
Faculty of Dental Medicine, Alaa Redwan, Umm Al-Qura University, Makkah, Saudi Arabia.
When is the study starting and how long is it expected to run for?
The study started recruiting participants in March 2024. Recruitment was completed in May 2025 and the study finished in May 2025.
Who is funding the study?
Faculty of Dental Medicine, Alaa Redwan, Umm Al-Qura University, Makkah, Saudi Arabia.
Who is the main contact?
Dr Alaa Redwan, akredwan@uqu.edu.sa
Contact information
Principal investigator, Scientific, Public
Umm Al-Qura University
Faculty of Dental Medicine
2373
Makkah
24381
Saudi Arabia
 ORCID ID |
0000-0002-7934-9939 |
|---|---|
| Phone | +966556672899 |
| akredwan@uqu.edu.sa |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Health services research, Treatment |
| Participant information sheet | 50279_PIS and Informed Consent Form.pdf |
| Scientific title | Virtual reality for pain and anxiety control during local anesthesia in a pediatric dental teaching clinic: a randomized controlled trial |
| Study objectives | |
| Ethics approval(s) |
Approved 01/01/2024, The Biomedical Research Ethics Committee at Umm Al-Qura University (Umm Al-Qura University, Makkah P.O.Box 715, Makkah, 24381, Saudi Arabia; +966125280347; cscenterQuqu.edu.sa), ref: HAPO-02-K-012-2024-01-1940 |
| Health condition(s) or problem(s) studied | Pain and anxiety during local anesthesia in pediatric dentistry |
| Intervention | Participants were randomly allocated to treatment groups using numbered, opaque, sealed envelopes to ensure allocation concealment. The first group received local anesthesia while using the VR device (intervention group) while the other received local anesthesia without the VR device (control group). The VR was placed for about 4-5 minutes depending on the child and the operator and that was only once during the LA insertion. |
| Intervention type | Device |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Virtual Reality (VR) |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 08/05/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 10 Years |
| Sex | All |
| Target sample size at registration | 90 |
| Total final enrolment | 85 |
| Key inclusion criteria | 1. No prior exposure to the dental setting or treatment procedures during the past 6 months 2. Classified as ASA I or II 3. Willing to participate in the study |
| Key exclusion criteria | Children or parents who refused participation in the study |
| Date of first enrolment | 21/03/2024 |
| Date of final enrolment | 08/05/2025 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 21/09/2026 | No | Yes | ||
| Protocol file | 21/09/2026 | No | No |
Additional files
- 50279_Protocol.pdf
- Protocol file
- 50279_PIS and Informed Consent Form.pdf
- Participant information sheet
Editorial Notes
14/09/2026: Study’s existence confirmed by the Biomedical Research Ethics Committee at Umm Al-Qura University, Saudi Arabia.
