Dental AnxietyNCT06698562
Virtual Reality and Laser Biostimulation on Pain Perception and Dental Anxiety
A study testing Distraction with Virtual reality glassess, Distraction with Virtual reality glassess + LLLT and Tell Show Do Group + LLLT in people with Dental Anxiety and Pain Intensity Assessment, run by SIRIN GUNER ONUR at 1 site in Turkey (Türkiye).
Trial summary
Dental anxiety in children can prevent planned treatment from being carried out, negatively affect the child's relationship with the dentist and make the treatment process difficult. The most common sources of directly anticipated anxiety are known to be associated with pain. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Pain Intensity Assessment
- What is being tested?
- Distraction with Virtual reality glassess, Distraction with Virtual reality glassess + LLLT and Tell Show Do Group + LLLT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2023to 15 May 2023
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- No history of systemic disease or infectious disease
- Compliant with the dental treatments to be performed in the Children's Dental Hospital and able to answer the questions asked
- Exhibiting 'positive' and 'absolutely positive' behaviours during the examination, compliant according to the Frankl scale,
- Children with no previous experience of dental treatment with local anaesthesia
Who cannot join
- Children with any systemic condition
- Mentally and physically disabled, unable to co-operate,
- Children allergic to local anaesthesia,
- Previous dental treatment experience with local anaesthesia
- Exhibiting "negative" and "strongly negative" behaviour according to the Frankl scale
- Children with eye diseases such as myopia and astigmatism
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Altinbas University Faculty of Dentistry
Istanbul, Marmara, 34147
About this study
Official title: Effect of Virtual Reality and Laser Biostimulation on Pain Perception and Dental Anxiety in Children
Dental anxiety in children can prevent planned treatment from being carried out, negatively affect the child's relationship with the dentist and make the treatment process difficult. The most common sources of directly anticipated anxiety are known to be associated with pain. Painful experiences are anxiety-provoking for people of all ages, especially children.This study aims to evaluate the effect of virtual reality glassess (VR) and low-level laser therapy (LLLT) on dental anxiety and pain perception during local anaesthesia administration in paediatric patients.
Read the detailed description
This study aims to investigate the combined effects of virtual reality glassess (VR) and low-level laser therapy (LLLT) on dental anxiety and pain perception in paediatric patients undergoing local anaesthesia for dental procedures. Dental anxiety is a common issue in children, often leading to increased pain perception and poor cooperation during treatment. Virtual reality has been proposed as a distraction technique, while LLLT is believed to reduce pain and inflammation. By exploring the effectiveness of these two interventions, the study seeks to determine whether VR and LLLT can serve as effective adjuncts to improve patient comfort, reduce anxiety, and enhance overall treatment experience during the administration of local anaesthesia
- Conditions
- Dental Anxiety, Pain Intensity Assessment
- Being tested
- Distraction with Virtual reality glassess, Distraction with Virtual reality glassess + LLLT, Tell Show Do Group + LLLT, Tell Show Do Group
- Keywords
- pain perception, dental anxiety, children, virtual reality, dental laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction with Virtual reality glassessOther
the injection site was dried with a cotton pellet and placebo topical anaesthesia was applied with a pre-sterilised wooden ear stick in a circular motion followed by laser biostimulation. The Wiser diode laser (Doctor Smile, Vicenza, Italy), a diode laser device with a wavelength of 980 nm and equipped with a 600 μm diameter fibre, was used to deliver low-level laser therapy to the area of interest. The tip of the laser carrier system was placed at a distance of 1 cm from the target tissue without contact and applied with continuous circular movements as recommended by the manufacturer. A silicone piece was placed on the end of the carrier system to ensure that the distance to the tissue remained constant in each application. The focal spot area was determined as 0.087 cm2. The power of the laser used in our study was determined as 0.3 W and the application time was selected as 60 seconds. The patient and the physician wore protective goggles during the whole procedure to prevent possi
Distraction with Virtual reality glassess + LLLTOther
The injection area was dried with a cotton pellet before injection. A topical anaesthetic gel containing 20% benzocaine (Vision pat gel) was applied to the mucosal tissues to be injected using a pre-sterilised ear stick. After the application of the topical anaesthetic agent, the laser device was positioned in the same way, but without applying energy, and the sound of the laser device was pre-recorded and the study was blinded. In this way, a placebo effect was created and the patient was prevented from distinguishing between the laser and non-laser session. After this procedure, local anaesthesia was applied.
Tell Show Do Group + LLLTOther
The injection site was dried with a cotton pellet and placebo topical anaesthesia was applied with a pre-sterilised wooden ear stick in a circular motion followed by laser biostimulation. The Wiser diode laser (Doctor Smile, Vicenza, Italy), a diode laser device with a wavelength of 980 nm and equipped with a 600 μm diameter fibre, was used to deliver low-level laser therapy to the area of interest. The tip of the laser carrier system was placed at a distance of 1 cm from the target tissue without contact and applied with continuous circular movements as recommended by the manufacturer. A silicone piece was placed on the end of the carrier system to ensure that the distance to the tissue remained constant in each application. The focal spot area was determined as 0.087 cm2. The power of the laser used in our study was determined as 0.3 W and the application time was selected as 60 seconds. During the whole procedure, the patient wore virtual glasses and the physician wore protective go
Tell Show Do GroupOther
Also called Group IIb
In this session, the injection area was dried with a cotton pellet before injection. A topical anaesthetic gel containing 20% benzocaine (Vision pat gel) was applied to the mucosal tissues to be injected using a pre-sterilised ear stick. After the application of the topical anaesthetic agent, the laser device was positioned in the same way, but without applying energy, and the sound of the laser device was pre-recorded and the study was blinded. In this way, a placebo effect was created and the patient was prevented from distinguishing between the laser and non-laser session. After this procedure, local anaesthesia was applied.
| Study group | Role | What they receive |
|---|---|---|
| Group IIa Tell- Show-Do | Active comparator | Placebo topical anesthesia + LLLT + Local anesthesia Receives: Other: Tell Show Do Group + LLLT; Other: Tell Show Do Group |
| Group IIb Tell- Show-Do | Placebo comparator | Topical anesthesia + placebo LLLT + Local anesthesia Receives: Other: Tell Show Do Group |
| Group Ia Distraction (VR) | Active comparator | Placebo topical anesthesia + LLLT + Local anesthesia Receives: Other: Distraction with Virtual reality glassess + LLLT |
| Grup Ib Distraction (VR) | Placebo comparator | Topical anesthesia + placebo LLLT + Local anesthesia Receives: Other: Distraction with Virtual reality glassess |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception
In this study, each patient received both topical anaesthesia and DSLT treatment using a split-mouth design.Pain perception was measured by Wong and Baker scale. In this scale there are 6 different facial expressions ranging from very happy to very unhappy to express the level of pain.The scale includes six faces, each illustrating a different level of pain intensity:
0 (No Pain), 1 (Very Mild Pain), 2 (Mild Pain), 3 (Moderate Pain), 4 (Severe Pain) 5 (Very Very Severe Pain). The Wong Baker facial expression pain scale was evaluated right before and immediately after the application of local anesthesia by an observer physician other than the physician administering local anesthesia. The pictures on this scale were introduced to the patient in an appropriate language. Right before and immediately after local anesthetic injection, the picture chosen by the patient was recorded on the scale.
Measured: Right before and immediately after treatment
Dental Anxiety
Dental anxiety levels of the children were physiologically evaluated using the 'Venham Picture Test'. The picture chosen by the patient was recorded on the scale. The Venham Picture Test was assessed right before and immediately after local anaesthetic injection by an observer clinician other than the clinician administering the local anesthesia. The children were shown 8 pairs of pictures of boys (one "anxious" picture and one "non-anxious" picture), each drawn in a contrasting mood, and were asked to choose the picture on each card that corresponded to their feelings. A score of 1 was given if the child chose the "anxious" picture and 0 if the child chose the "non-anxious" picture. To determine the total score, the number of "anxious" pictures was summed (lowest score 0, highest score 8).
Measured: Right before and immediately after treatment
Pain perception
The "Face, Legs, Activity, Cry, Consolability (FLACC)" pain assessment scale was also evaluated during local anesthesia application by an observer clinician other than the clinician to whom local anesthesia would be applied. The patient's reactions were evaluated by observation by the researcher. Pain values were determined between 0-2 for each parameter and 0-10 for the total scale score. According to the scale, the total score was evaluated as follows: 0: No pain, 1-3: Mild pain, 4-6: Moderate pain and discomfort, 7-10: Severe pain and discomfort.
Measured: During local anesthesia application
Secondary outcomes (1)
Dental Anxiety
Pulse rate and oxygen saturation values were measured with a pulse oximetry device. The measurement was started by attaching the finger apparatus of the device to the index finger of the left hand of the patients. Then, the pulse and SpO2 values right before, during and immediately after the application of local anesthesia were recorded. At the end of the session, these values were averaged and recorded in the case report form.
Measured: Right before, during and immediately after the application of local anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start3 Jan 2023
- Primary completion25 Apr 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study included 40 Frankl "positive" and "definitely positive" pediatric patients between the ages of 6 and 10, applied to Altinbaş University Faculty of Dentistry Pediatric Dentistry Clinic for routine dental treatments between January 2023 and April 2023, and had no previous local anesthesia experience. This study designed as a randomized, single-center, split-mouth, double blind clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- SIRIN GUNER ONUR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SIRIN GUNER ONUR, Altinbas University
- Investigators
- SIRIN GUNER ONUR, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698562
- Sponsor's protocol ID
- 2022/143
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 21 Nov 2024
- 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 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality and Laser Biostimulation on Pain Perception and Dental Anxiety in Children
- ClinicalTrials.gov ID
- NCT06698562
- Acronym / sponsor ID
- 2022/143
- Conditions
- Dental Anxiety, Pain Intensity Assessment
- Keywords
- pain perception, dental anxiety, children, virtual reality, dental laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- SIRIN GUNER ONURUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 21 Nov 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.
Dental anxiety in children can prevent planned treatment from being carried out, negatively affect the child's relationship with the dentist and make the treatment process difficult. The most common sources of directly anticipated anxiety are known to be associated with pain. Painful experiences are anxiety-provoking for people of all ages, especially children.This study aims to evaluate the effect of virtual reality glassess (VR) and low-level laser therapy (LLLT) on dental anxiety and pain perception during local anaesthesia administration in paediatric patients.
Detailed description
This study aims to investigate the combined effects of virtual reality glassess (VR) and low-level laser therapy (LLLT) on dental anxiety and pain perception in paediatric patients undergoing local anaesthesia for dental procedures. Dental anxiety is a common issue in children, often leading to increased pain perception and poor cooperation during treatment. Virtual reality has been proposed as a distraction technique, while LLLT is believed to reduce pain and inflammation. By exploring the effectiveness of these two interventions, the study seeks to determine whether VR and LLLT can serve as effective adjuncts to improve patient comfort, reduce anxiety, and enhance overall treatment experience during the administration of local anaesthesia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- The study included 40 Frankl "positive" and "definitely positive" pediatric patients between the ages of 6 and 10, applied to Altinbaş University Faculty of Dentistry Pediatric Dentistry Clinic for routine dental treatments between January 2023 and April 2023, and had no previous local anesthesia experience. This study designed as a randomized, single-center, split-mouth, double blind clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Group IIa Tell- Show-Do | Active comparator | Other: Tell Show Do Group + LLLT, Other: Tell Show Do GroupPlacebo topical anesthesia + LLLT + Local anesthesia |
| Group IIb Tell- Show-Do | Placebo comparator | Other: Tell Show Do GroupTopical anesthesia + placebo LLLT + Local anesthesia |
| Group Ia Distraction (VR) | Active comparator | Other: Distraction with Virtual reality glassess + LLLTPlacebo topical anesthesia + LLLT + Local anesthesia |
| Grup Ib Distraction (VR) | Placebo comparator | Other: Distraction with Virtual reality glassessTopical anesthesia + placebo LLLT + Local anesthesia |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- No history of systemic disease or infectious disease
- Compliant with the dental treatments to be performed in the Children's Dental Hospital and able to answer the questions asked
- Exhibiting 'positive' and 'absolutely positive' behaviours during the examination, compliant according to the Frankl scale,
- Children with no previous experience of dental treatment with local anaesthesia
Key exclusion criteria (6 listed)
- Children with any systemic condition
- Mentally and physically disabled, unable to co-operate,
- Children allergic to local anaesthesia,
- Previous dental treatment experience with local anaesthesia
- Exhibiting "negative" and "strongly negative" behaviour according to the Frankl 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 |
|---|---|---|
| Distraction with Virtual reality glassessthe injection site was dried with a cotton pellet and placebo topical anaesthesia was applied with a pre-sterilised wooden ear stick in a circular motion followed by laser biostimulation. The Wiser diode laser (Doctor Smile, Vicenza, Italy), a diode laser device with a wavelength of 980 nm and equipped with a 600 μm diameter fibre, was used to deliver low-level laser therapy to the area of interest. The tip of the laser carrier system was placed at a distance of 1 cm from the target tissue without contact and applied with continuous circular movements as recommended by the manufacturer. A silicone piece was placed on the end of the carrier system to ensure that the distance to the tissue remained constant in each application. The focal spot area was determined as 0.087 cm2. The power of the laser used in our study was determined as 0.3 W and the application time was selected as 60 seconds. The patient and the physician wore protective goggles during the whole procedure to prevent possi | Other | Grup Ib Distraction (VR) |
| Distraction with Virtual reality glassess + LLLTThe injection area was dried with a cotton pellet before injection. A topical anaesthetic gel containing 20% benzocaine (Vision pat gel) was applied to the mucosal tissues to be injected using a pre-sterilised ear stick. After the application of the topical anaesthetic agent, the laser device was positioned in the same way, but without applying energy, and the sound of the laser device was pre-recorded and the study was blinded. In this way, a placebo effect was created and the patient was prevented from distinguishing between the laser and non-laser session. After this procedure, local anaesthesia was applied. | Other | Group Ia Distraction (VR) |
| Tell Show Do Group + LLLTThe injection site was dried with a cotton pellet and placebo topical anaesthesia was applied with a pre-sterilised wooden ear stick in a circular motion followed by laser biostimulation. The Wiser diode laser (Doctor Smile, Vicenza, Italy), a diode laser device with a wavelength of 980 nm and equipped with a 600 μm diameter fibre, was used to deliver low-level laser therapy to the area of interest. The tip of the laser carrier system was placed at a distance of 1 cm from the target tissue without contact and applied with continuous circular movements as recommended by the manufacturer. A silicone piece was placed on the end of the carrier system to ensure that the distance to the tissue remained constant in each application. The focal spot area was determined as 0.087 cm2. The power of the laser used in our study was determined as 0.3 W and the application time was selected as 60 seconds. During the whole procedure, the patient wore virtual glasses and the physician wore protective go | Other | Group IIa Tell- Show-Do |
| Tell Show Do GroupAlso: Group IIbIn this session, the injection area was dried with a cotton pellet before injection. A topical anaesthetic gel containing 20% benzocaine (Vision pat gel) was applied to the mucosal tissues to be injected using a pre-sterilised ear stick. After the application of the topical anaesthetic agent, the laser device was positioned in the same way, but without applying energy, and the sound of the laser device was pre-recorded and the study was blinded. In this way, a placebo effect was created and the patient was prevented from distinguishing between the laser and non-laser session. After this procedure, local anaesthesia was applied. | Other | Group IIa Tell- Show-Do, Group IIb Tell- Show-Do |
Primary outcome
Pain perception
Time frame: Right before and immediately after treatment
In this study, each patient received both topical anaesthesia and DSLT treatment using a split-mouth design.Pain perception was measured by Wong and Baker scale. In this scale there are 6 different facial expressions ranging from very happy to very unhappy to express the level of pain.The scale includes six faces, each illustrating a different level of pain intensity: 0 (No Pain), 1 (Very Mild Pain), 2 (Mild Pain), 3 (Moderate Pain), 4 (Severe Pain) 5 (Very Very Severe Pain). The Wong Baker facial expression pain scale was evaluated right before and immediately after the application of local anesthesia by an observer physician other than the physician administering local anesthesia. The pictures on this scale were introduced to the patient in an appropriate language. Right before and immediately after local anesthetic injection, the picture chosen by the patient was recorded on the scale.
Dental Anxiety
Time frame: Right before and immediately after treatment
Dental anxiety levels of the children were physiologically evaluated using the 'Venham Picture Test'. The picture chosen by the patient was recorded on the scale. The Venham Picture Test was assessed right before and immediately after local anaesthetic injection by an observer clinician other than the clinician administering the local anesthesia. The children were shown 8 pairs of pictures of boys (one "anxious" picture and one "non-anxious" picture), each drawn in a contrasting mood, and were asked to choose the picture on each card that corresponded to their feelings. A score of 1 was given if the child chose the "anxious" picture and 0 if the child chose the "non-anxious" picture. To determine the total score, the number of "anxious" pictures was summed (lowest score 0, highest score 8).
Pain perception
Time frame: During local anesthesia application
The "Face, Legs, Activity, Cry, Consolability (FLACC)" pain assessment scale was also evaluated during local anesthesia application by an observer clinician other than the clinician to whom local anesthesia would be applied. The patient's reactions were evaluated by observation by the researcher. Pain values were determined between 0-2 for each parameter and 0-10 for the total scale score. According to the scale, the total score was evaluated as follows: 0: No pain, 1-3: Mild pain, 4-6: Moderate pain and discomfort, 7-10: Severe pain and discomfort.
1 secondary outcome
Dental Anxiety
Time frame: Right before, during and immediately after the application of local anesthesia
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 21 Nov 2024.
- Individual participant dataSharing planned: No
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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.
SIRIN GUNER ONUR, PhD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction with Virtual reality glassess, Distraction with Virtual reality glassess + LLLT and Tell Show Do Group + LLLT in people with Dental Anxiety and Pain Intensity Assessment, run by SIRIN GUNER ONUR at 1 site in Turkey (Türkiye).
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 6 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 21 Nov 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 Turkey (Türkiye). 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.
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?
Pain perception (time frame: Right before and immediately after treatment). The study lists 3 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 21 Nov 2024.