Dental AnxietyNCT06788301
Dental Anxiety and Pain During Inferior Alveolar Nerve Block in Children: the Effects of Two Distraction Techniques
A study testing Inferior Alveolar Nerve Block, VR eyeglasses and Buzzy device in people with Dental Anxiety and Pain, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Objectives: To compare the effectiveness of virtual reality (VR) and external cooling and vibration distraction techniques on dental anxiety and pain in children during inferior alveolar nerve block (IANB). Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Pain, Distraction Methods
- What is being tested?
- Inferior Alveolar Nerve Block, VR eyeglasses and Buzzy device
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2022to 20 Apr 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 6-12 years without any systemic disease and physical and/or mental disorders,
- Children whose behavior rating were positive and definitely positive according to the Frankl Behavior Scale (FBS),
- Children with no known allergy to any medication or local anesthetic,
- Children who had mandibular primary/permanent molar requiring dental treatment under an IANB,
- Children with no previous experience of local anesthesia.
Who cannot join
- Children with systemic disease or neurological behaviour disorders,
- Children whose behavior rating were negative and definitely negative according to the FBS,
- Children with history of allergy to any medication or local anesthetic,
- Children who exhibeted any kind of dento-facial abnormality/syndrome that lead to administration of local anesthesia difficult,
- Children with previous experience of local anesthesia, and non-Turkish speaking
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University, Faculty of Dentistry, Department of Pediatric Dentistry
Denizli, 20160
About this study
Official title: The Effects of Virtual Reality and External Cooling and Vibration on Dental Anxiety and Pain During Inferior Alveolar Nerve Block in Children: a Randomized Clinical Trial
Objectives: To compare the effectiveness of virtual reality (VR) and external cooling and vibration distraction techniques on dental anxiety and pain in children during inferior alveolar nerve block (IANB).
Materials and Methods: This randomized controlled parallel arm trial included 120 children aged between 6-12 years old who required IANB. Children were randomly divided following three groups: Group I: VR eyeglasses, Group II: Buzzy® device, and Group 3: Control (conventional behavior management technique). Dental anxiety levels were measured by the pulse rate and oxygen saturation level before, during, and after IANB procedure. Pain perception during IANB procedure was assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale, Wong Baker Faces Scale (WBS), and Visual Analog Scale (VAS).
Read the detailed description
This study was designed as a three-arm parallel randomized controlled trial to compare the effects of virtual reality (VR) and external cooling and vibration on dental anxiety and pain during inferior alveolar nerve block (IANB) in children aged 6 to 12 years old.
The sample size consisted of 120 children, and the patients were randomly divided following three different groups: Group I: VR eyeglasses group, Group II: Buzzy® device group, and Group III: Control group.
Group I (VR eylasses): In the present study, 3D VR eyeglasses (Oculus Quest 2, Oculus Go, Facebook Technologies, Auburn, USA) were used for VR distraction.
Group II (Buzzy® device): In the present study, the Buzzy® device (MMJ Labs, Atlanta, GA, USA), consisting of a bee-shaped vibrating body and removable wing-shaped cold gel packs, was used for external cooling and vibration application.
Group III (Control): In the present study, group III received conventional behavior management technique (tell-show-do) during the administration of IANB.
Administration of IANB: The oral mucosa was dried with air-water spray and topical anesthetic solution (Vemcaine %10 Lidocaine, VEM Co. Ltd., Istanbul, Turkey) was applied to the dry mucosa with a cotton pellet for 1 minute. The patient was asked to open his/her mouth as wide as possible, and then IANB was administred using 2 ml of 4% articaine with 1:100.000 adrenaline (Ultracaine DS® Forte, Sanofi Health Products Co. Ltd., Istanbul, Turkey) using an automatic aspirated Aspiject® carpule syringe (RØNVIG Dental Mfg. A/S, Daugaard, Denmark) with a 35 mm 27 gauge needle at a rate of 1 ml/minute. In order to ensure standardisation, each patient received the same dosage of local anesthetic and the IANB procedure was provided by the same investigator.
Dental anxiety and pain assessment In order to evaluate physiological changes associated with anxiety, oxygen saturation (SpO2) and pulse rate (PR) values were recorded using pediatric fingertip pulse oximeter (ChoiceMMed, Beijing Choice Electronic Technology Co., Ltd, China) 1 minutes before, during, and 1 minutes after the administration of IANB.
For objective assessment of pain during the IANB procedure, the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Assessment Scale was used. The FLACC scores were assessed by another investigator not involved in the IANB procedure.
The Wong Baker Face (WBS) and the Visual Analog Scale (VAS), two commonly used and valid pain measurment scale for pediatric patients, were used to assess the self perception of pain. Both scales were explained to the patients, and they were asked to choose the facial expression (for WBS) and the number (for VAS) that best reflected their current level of pain during the IANB procedure.
- Conditions
- Dental Anxiety, Pain, Distraction Methods, Local Anesthesia
- Being tested
- Inferior Alveolar Nerve Block, VR eyeglasses, Buzzy device
- Keywords
- Dental anxiety, Distraction, Local Anethesia, Pain, Pediatric Dentistry
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior Alveolar Nerve BlockProcedure or surgery
local anesthesia administration (inferior alveolar nerve block)
VR eyeglassesDevice
VR eyeglasses was used to distarct patients from dental environment during inferior alveolar nerve block.
Buzzy deviceDevice
Buzzy device was used to distarct patients from dental environment during inferior alveolar nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Group I (VR eyeglasses) | Experimental | In the VR group, patients wore a VR eyeglasses (Oculus Quest 2, Oculustm Go, Facebook Technologies, Auburn, USA) and watched a previously selected favorite cartoon during the IANB procedure. Receives: Procedure: Inferior Alveolar Nerve Block; Device: VR eyeglasses |
| Group II (Buzzy device) | Experimental | In the Buzzy device group, the Buzzy® device (MMJ Labs, Atlanta, GA, USA) was placed extra-orally on the site of IANB (right/left mandibula) during the administration of IANB. Receives: Procedure: Inferior Alveolar Nerve Block; Device: Buzzy device |
| Group III (Control) | Other | In the control group, patients received conventional behavior management technique (tell-show-do) during the administration of IANB. Prior to the IANB procedure, the instruments to be used and procedure were explained to the patient in phrases suitable for the patient's cognitive level. Receives: Procedure: Inferior Alveolar Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation
The physiological response of dental anxiety to inferior alveolar nerve block was evaluated by parameters of oxygen saturation value.
Measured: 1 minutes before, during, and 1 minutes after the administration of inferior alveolar nerve block
Pulse rate
The physiological response of dental anxiety to inferior alveolar nerve block was evaluated by parameters of pulse rate value.
Measured: 1 minutes before, during, and 1 minutes after the administration of inferior alveolar nerve block
Objective pain assessment
For objective assessment of pain during the inferior alveolar nerve block procedure, the Face, Legs, Activity, Cry, Consolability Behavioral Pain Assessment Scale (0-10) was used. (0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-10: severe pain)
Measured: During the inferior alveolar nerve block procedure.
Self perception of pain
The Wong Baker Face Scale (0-10) was used to assess the self perception of pain. (0: no pain, 10: severe pain)
Measured: Immediately after the inferior alveolar nerve block procedure.
Self perception of pain
The Visual Analog Scale (0-10) was used to assess the self perception of pain. (0: no pain, 10: severe pain)
Measured: Immediately after the inferior alveolar nerve block procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start20 Jul 2022
- Primary completion20 Apr 2023
- Study completion20 Apr 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.
- More trials run by Pamukkale 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arif Bolaca, Pamukkale University
- Investigators
- Arif Bolaca, Dr., Study director, Pamukkale University Faculty of DentistryAybüke ipek Atik, Dr., Principal investigator, Pamukkale University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788301
- Sponsor's protocol ID
- 2022DİŞF003
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- 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 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Virtual Reality and External Cooling and Vibration on Dental Anxiety and Pain During Inferior Alveolar Nerve Block in Children: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06788301
- Acronym / sponsor ID
- 2022DİŞF003
- Conditions
- Dental Anxiety, Pain, Distraction Methods, Local Anesthesia
- Keywords
- Dental anxiety, Distraction, Local Anethesia, Pain, Pediatric Dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 23 Jan 2025 (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.
Objectives: To compare the effectiveness of virtual reality (VR) and external cooling and vibration distraction techniques on dental anxiety and pain in children during inferior alveolar nerve block (IANB).
Materials and Methods: This randomized controlled parallel arm trial included 120 children aged between 6-12 years old who required IANB. Children were randomly divided following three groups: Group I: VR eyeglasses, Group II: Buzzy® device, and Group 3: Control (conventional behavior management technique). Dental anxiety levels were measured by the pulse rate and oxygen saturation level before, during, and after IANB procedure. Pain perception during IANB procedure was assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale, Wong Baker Faces Scale (WBS), and Visual Analog Scale (VAS).
Detailed description
This study was designed as a three-arm parallel randomized controlled trial to compare the effects of virtual reality (VR) and external cooling and vibration on dental anxiety and pain during inferior alveolar nerve block (IANB) in children aged 6 to 12 years old.
The sample size consisted of 120 children, and the patients were randomly divided following three different groups: Group I: VR eyeglasses group, Group II: Buzzy® device group, and Group III: Control group.
Group I (VR eylasses): In the present study, 3D VR eyeglasses (Oculus Quest 2, Oculus Go, Facebook Technologies, Auburn, USA) were used for VR distraction.
Group II (Buzzy® device): In the present study, the Buzzy® device (MMJ Labs, Atlanta, GA, USA), consisting of a bee-shaped vibrating body and removable wing-shaped cold gel packs, was used for external cooling and vibration application.
Group III (Control): In the present study, group III received conventional behavior management technique (tell-show-do) during the administration of IANB.
Administration of IANB: The oral mucosa was dried with air-water spray and topical anesthetic solution (Vemcaine %10 Lidocaine, VEM Co. Ltd., Istanbul, Turkey) was applied to the dry mucosa with a cotton pellet for 1 minute. The patient was asked to open his/her mouth as wide as possible, and then IANB was administred using 2 ml of 4% articaine with 1:100.000 adrenaline (Ultracaine DS® Forte, Sanofi Health Products Co. Ltd., Istanbul, Turkey) using an automatic aspirated Aspiject® carpule syringe (RØNVIG Dental Mfg. A/S, Daugaard, Denmark) with a 35 mm 27 gauge needle at a rate of 1 ml/minute. In order to ensure standardisation, each patient received the same dosage of local anesthetic and the IANB procedure was provided by the same investigator.
Dental anxiety and pain assessment In order to evaluate physiological changes associated with anxiety, oxygen saturation (SpO2) and pulse rate (PR) values were recorded using pediatric fingertip pulse oximeter (ChoiceMMed, Beijing Choice Electronic Technology Co., Ltd, China) 1 minutes before, during, and 1 minutes after the administration of IANB.
For objective assessment of pain during the IANB procedure, the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Assessment Scale was used. The FLACC scores were assessed by another investigator not involved in the IANB procedure.
The Wong Baker Face (WBS) and the Visual Analog Scale (VAS), two commonly used and valid pain measurment scale for pediatric patients, were used to assess the self perception of pain. Both scales were explained to the patients, and they were asked to choose the facial expression (for WBS) and the number (for VAS) that best reflected their current level of pain during the IANB procedure.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (VR eyeglasses) | Experimental | Procedure: Inferior Alveolar Nerve Block, Device: VR eyeglassesIn the VR group, patients wore a VR eyeglasses (Oculus Quest 2, Oculustm Go, Facebook Technologies, Auburn, USA) and watched a previously selected favorite cartoon during the IANB procedure. |
| Group II (Buzzy device) | Experimental | Procedure: Inferior Alveolar Nerve Block, Device: Buzzy deviceIn the Buzzy device group, the Buzzy® device (MMJ Labs, Atlanta, GA, USA) was placed extra-orally on the site of IANB (right/left mandibula) during the administration of IANB. |
| Group III (Control) | Other | Procedure: Inferior Alveolar Nerve BlockIn the control group, patients received conventional behavior management technique (tell-show-do) during the administration of IANB. Prior to the IANB procedure, the instruments to be used and procedure were explained to the patient in phrases suitable for the patient's cognitive level. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged between 6-12 years without any systemic disease and physical and/or mental disorders,
- Children whose behavior rating were positive and definitely positive according to the Frankl Behavior Scale (FBS),
- Children with no known allergy to any medication or local anesthetic,
- Children who had mandibular primary/permanent molar requiring dental treatment under an IANB,
- Children with no previous experience of local anesthesia.
Key exclusion criteria (5 listed)
- Children with systemic disease or neurological behaviour disorders,
- Children whose behavior rating were negative and definitely negative according to the FBS,
- Children with history of allergy to any medication or local anesthetic,
- Children who exhibeted any kind of dento-facial abnormality/syndrome that lead to administration of local anesthesia difficult,
- Children with previous experience of local anesthesia, and non-Turkish speaking
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 |
|---|---|---|
| Inferior Alveolar Nerve Blocklocal anesthesia administration (inferior alveolar nerve block) | Procedure or surgery | Group I (VR eyeglasses), Group II (Buzzy device), Group III (Control) |
| VR eyeglassesVR eyeglasses was used to distarct patients from dental environment during inferior alveolar nerve block. | Device | Group I (VR eyeglasses) |
| Buzzy deviceBuzzy device was used to distarct patients from dental environment during inferior alveolar nerve block. | Device | Group II (Buzzy device) |
Primary outcome
Oxygen saturation
Time frame: 1 minutes before, during, and 1 minutes after the administration of inferior alveolar nerve block
The physiological response of dental anxiety to inferior alveolar nerve block was evaluated by parameters of oxygen saturation value.
Pulse rate
Time frame: 1 minutes before, during, and 1 minutes after the administration of inferior alveolar nerve block
The physiological response of dental anxiety to inferior alveolar nerve block was evaluated by parameters of pulse rate value.
Objective pain assessment
Time frame: During the inferior alveolar nerve block procedure.
For objective assessment of pain during the inferior alveolar nerve block procedure, the Face, Legs, Activity, Cry, Consolability Behavioral Pain Assessment Scale (0-10) was used. (0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-10: severe pain)
Self perception of pain
Time frame: Immediately after the inferior alveolar nerve block procedure.
The Wong Baker Face Scale (0-10) was used to assess the self perception of pain. (0: no pain, 10: severe pain)
Self perception of pain
Time frame: Immediately after the inferior alveolar nerve block procedure.
The Visual Analog Scale (0-10) was used to assess the self perception of pain. (0: no pain, 10: severe pain)
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 23 Jan 2025.
- 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.
Arif Bolaca, Dr. study director
Pamukkale University Faculty of Dentistry
Aybüke ipek Atik, Dr. principal investigator
Pamukkale University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inferior Alveolar Nerve Block, VR eyeglasses and Buzzy device in people with Dental Anxiety and Pain, run by Pamukkale University 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 5 inclusion and 5 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 23 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 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. 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?
Oxygen saturation (time frame: 1 minutes before, during, and 1 minutes after the administration of inferior alveolar nerve block). The study lists 5 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 23 Jan 2025.