Objective Pain and DiscomfortNCT07376941
The Effect of Virtual Reality Distraction on Pain and Discomfort Associated With Bitewing Radiographs in Pediatric Patients
A study testing virtual reality device goggles in people with Objective Pain and Discomfort and Subjective Pain and Discomfort, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
This study will be conducted at King Abdulaziz University Dental Hospital (KAUDH). Ethical approval was obtained from the Research Ethics Committee of the Faculty of Dentistry at King Abdulaziz University (32-03-25). Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Objective Pain and Discomfort, Subjective Pain and Discomfort, Behavior
- What is being tested?
- virtual reality device goggles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2026to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy
- Cooperative children
- Aged 4 to 12 years
- Referred to the radiology department for two-bitewing radiographs.
Who cannot join
- 1- Children with a history of epilepsy or anxiety disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study will be conducted at King Abdulaziz University Dental Hospital (KAUDH). Ethical approval was obtained from the Research Ethics Committee of the Faculty of Dentistry at King Abdulaziz University (32-03-25).
Inclusion criteria will include healthy and cooperative children aged 4 to 12 years who are referred to the radiology department for two-bitewing radiographs. Children with a history of epilepsy or anxiety disorder will be excluded. The study's purpose, risks, benefits, and limitations will be explained to the parents or guardians of eligible children by trained dental interns. Those who agree to participate will be asked to sign an Arabic consent form before their involvement. Additionally, an assent form will be obtained from children aged seven and older.
Read more
Subjects' age, gender, previous dental experience, and behavior during previous dental visits, as assessed by Frankl's behavior rating scale , will be recorded, along with whether they own or have prior exposure to a virtual reality device. Only children with cooperative and definitely cooperative behavior will be included.
A randomization sequence with an allocation ratio of 1:1 will be generated using computer software and kept with a radiology assistant who is not involved in the study to ensure allocation concealment. Due to the nature of the study, neither the subject nor the radiologist will be blinded to the group allocation. However, the statistician will be blinded to which group each subject will be allocated.
Before taking the radiographs, subjects will be asked to select a video from a list of popular cartoon shows or a video of their preference. In the test group, the subjects will wear virtual reality device goggles (LG 360 virtual reality [VR] headset, LG Electronics) connected to a mobile phone, and the chosen video will be played. In the control group, radiographs will be taken without the use of any distraction device. The sounds of the videos will be played on headphones. All bitewing radiographs will be taken by the same radiologist, following the As Low As Reasonably Achievable (ALARA) protocol and hospital guidelines. The procedure uses either size one or size two bitewing Photostimulable Phosphor digital sensors, along with a film holder and a rectangular collimator. While taking the radiographs, the Tell-Show-Do behavior management technique will be used with all participating children, and they will be recorded with a high-resolution camera.
The camera will aim toward the face and the body. Later, two trained and calibrated evaluators will independently assess the participating children's behavioral pain using the face, legs, activity, cry, and consolability (FLACC) behavioral pain assessment scale. The FLACC scale ranges from 0 to 10, with 0 indicating no pain and 10 the worst possible pain. Additionally, the behavior during the BWS will also be recorded using Frankl's behavior rating scale classification. Training and calibration for the evaluators will involve watching videos of 20 randomly selected children during their dental treatment. A stopwatch will be used to measure the chair time required to take the radiographs. In the test group, the time needed to place the VR device will be included.
Immediately after taking the BWS, the subjects will be shown the Arabic version of the Wong-Baker FACES pain rating scale. They will be asked to select the face that best describes their feelings during the procedure. Finally, the satisfaction with the use of VR during BWS taking will be assessed using a five-point Likert scale, where zero indicates 'not satisfied at all' and 10 means' very satisfied'. Subjects who require repeating any of the BWS will be excluded from the study
- Conditions
- Objective Pain and Discomfort, Subjective Pain and Discomfort, Behavior, Satisfaction, Future Preferences
- Being tested
- virtual reality device goggles
- Keywords
- Satisfaction, Virtual Reality, Bitewings Radiographs
- Medical subject headings
- Behavior, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality device gogglesOther
virtual reality device goggles (LG 360 virtual reality [VR] headset, LG Electronics)
| Study group | Role | What they receive |
|---|---|---|
| In the test group, the subjects will wear VR device goggles. | Experimental | In the test group, the subjects will wear VR device goggles (LG 360 virtual reality [VR] headset, LG Electronics) connected to a mobile phone, and the chosen video will be played. Receives: Other: virtual reality device goggles |
| In the control group, radiographs will be taken without the use of any distraction device. | No intervention | In the control group, radiographs will be taken without the use of any distraction device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective main and discomfort
The camera will aim toward the face and the body. Later, two trained and calibrated evaluators will independently assess the participating children's behavioral pain using the FLACC scale. The FLACC scale ranges from 0 to 10, with 0 indicating no pain and 10 the worst possible pain.
Measured: While taking the BWS radiographs.
Subjective pain and discomfort
Immediately after taking the BWS, the subjects will be shown the Arabic version of the Wong-Baker FACES pain rating scale. They will be asked to select the face that best describes their feelings during the procedure. The participants choose the face that best describes their current feelings, ranging from 0 (no hurt) to 10 (worst pain).
Measured: Immediately after taking the BWS.
Secondary outcomes (2)
The behavior during the radiograph procedure.
The camera will aim toward the face and the body. Later, two trained and calibrated evaluators will independently assess the participating children's behavior during the radiograph procedure will also be recorded using Frankl's behavior rating scale classification
Measured: While taking the BWS radiographs
Satisfaction of the use of virtual reality
The satisfaction with the use of VR during radiograph taking will be assessed using a five-point Likert scale, where zero indicates 'not satisfied at all' and 10 means' very satisfied'.
Measured: Immediately after taking the BWS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Objective Pain and DiscomfortStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the test group, subjects wore VR goggles (LG 360G Electronics) connected to a mobile phone, and a VR headset; the selected video was played. In the control group, BWS were taken without the use of any distraction device.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mustafa Bagher, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376941
- Sponsor's protocol ID
- KingAbdulazizU
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Distraction on Pain and Discomfort Associated With Bitewing Radiographs in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07376941
- Acronym / sponsor ID
- KingAbdulazizU
- Conditions
- Objective Pain and Discomfort, Subjective Pain and Discomfort, Behavior, Satisfaction, Future Preferences
- Keywords
- Satisfaction, Virtual Reality, Bitewings Radiographs
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 29 Jan 2026 (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.
This study will be conducted at King Abdulaziz University Dental Hospital (KAUDH). Ethical approval was obtained from the Research Ethics Committee of the Faculty of Dentistry at King Abdulaziz University (32-03-25).
Inclusion criteria will include healthy and cooperative children aged 4 to 12 years who are referred to the radiology department for two-bitewing radiographs. Children with a history of epilepsy or anxiety disorder will be excluded. The study's purpose, risks, benefits, and limitations will be explained to the parents or guardians of eligible children by trained dental interns. Those who agree to participate will be asked to sign an Arabic consent form before their involvement. Additionally, an assent form will be obtained from children aged seven and older.
Subjects' age, gender, previous dental experience, and behavior during previous dental visits, as assessed by Frankl's behavior rating scale , will be recorded, along with whether they own or have prior exposure to a virtual reality device. Only children with cooperative and definitely cooperative behavior will be included.
A randomization sequence with an allocation ratio of 1:1 will be generated using computer software and kept with a radiology assistant who is not involved in the study to ensure allocation concealment. Due to the nature of the study, neither the subject nor the radiologist will be blinded to the group allocation. However, the statistician will be blinded to which group each subject will be allocated.
Before taking the radiographs, subjects will be asked to select a video from a list of popular cartoon shows or a video of their preference. In the test group, the subjects will wear virtual reality device goggles (LG 360 virtual reality [VR] headset, LG Electronics) connected to a mobile phone, and the chosen video will be played. In the control group, radiographs will be taken without the use of any distraction device. The sounds of the videos will be played on headphones. All bitewing radiographs will be taken by the same radiologist, following the As Low As Reasonably Achievable (ALARA) protocol and hospital guidelines. The procedure uses either size one or size two bitewing Photostimulable Phosphor digital sensors, along with a film holder and a rectangular collimator. While taking the radiographs, the Tell-Show-Do behavior management technique will be used with all participating children, and they will be recorded with a high-resolution camera.
The camera will aim toward the face and the body. Later, two trained and calibrated evaluators will independently assess the participating children's behavioral pain using the face, legs, activity, cry, and consolability (FLACC) behavioral pain assessment scale. The FLACC scale ranges from 0 to 10, with 0 indicating no pain and 10 the worst possible pain. Additionally, the behavior during the BWS will also be recorded using Frankl's behavior rating scale classification. Training and calibration for the evaluators will involve watching videos of 20 randomly selected children during their dental treatment. A stopwatch will be used to measure the chair time required to take the radiographs. In the test group, the time needed to place the VR device will be included.
Immediately after taking the BWS, the subjects will be shown the Arabic version of the Wong-Baker FACES pain rating scale. They will be asked to select the face that best describes their feelings during the procedure. Finally, the satisfaction with the use of VR during BWS taking will be assessed using a five-point Likert scale, where zero indicates 'not satisfied at all' and 10 means' very satisfied'. Subjects who require repeating any of the BWS will be excluded from the study
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In the test group, subjects wore VR goggles (LG 360G Electronics) connected to a mobile phone, and a VR headset; the selected video was played. In the control group, BWS were taken without the use of any distraction device.
| Arm | Type | Receives |
|---|---|---|
| In the test group, the subjects will wear VR device goggles. | Experimental | Other: virtual reality device gogglesIn the test group, the subjects will wear VR device goggles (LG 360 virtual reality [VR] headset, LG Electronics) connected to a mobile phone, and the chosen video will be played. |
| In the control group, radiographs will be taken without the use of any distraction device. | No intervention | –In the control group, radiographs will be taken without the use of any distraction device. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy
- Cooperative children
- Aged 4 to 12 years
- Referred to the radiology department for two-bitewing radiographs.
Key exclusion criteria (1 listed)
- 1- Children with a history of epilepsy or anxiety disorder
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 device gogglesvirtual reality device goggles (LG 360 virtual reality [VR] headset, LG Electronics) | Other | In the test group, the subjects will wear VR device goggles. |
Primary outcome
Objective main and discomfort
Time frame: While taking the BWS radiographs.
The camera will aim toward the face and the body. Later, two trained and calibrated evaluators will independently assess the participating children's behavioral pain using the FLACC scale. The FLACC scale ranges from 0 to 10, with 0 indicating no pain and 10 the worst possible pain.
Subjective pain and discomfort
Time frame: Immediately after taking the BWS.
Immediately after taking the BWS, the subjects will be shown the Arabic version of the Wong-Baker FACES pain rating scale. They will be asked to select the face that best describes their feelings during the procedure. The participants choose the face that best describes their current feelings, ranging from 0 (no hurt) to 10 (worst pain).
2 secondary outcomes
The behavior during the radiograph procedure.
Time frame: While taking the BWS radiographs
Satisfaction of the use of virtual reality
Time frame: Immediately after taking the BWS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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.
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 goggles in people with Objective Pain and Discomfort and Subjective Pain and Discomfort, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 29 Jan 2026. 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 Saudi Arabia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Mustafa Bagher, Associate Professor (00966547433525, sbagher@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective main and discomfort (time frame: While taking the BWS radiographs.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2026.