Injection PainNCT03772483
Efficacy of Virtual Reality in Reducing Injection Pain and Anxiety During Local Anesthesia in Children
A study testing Local anesthesia with conventional syringe and Local anesthesia with conventional syringe + VR device in people with Injection Pain and Local Anesthesia, run by Plovdiv Medical University at 1 site in Bulgaria.
Trial summary
The aim of this study is to determine the efficacy of a virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients. The clinical trial is a randomized split-mouth assignment. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Pain, Local Anesthesia
- What is being tested?
- Local anesthesia with conventional syringe and Local anesthesia with conventional syringe + VR device
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBulgaria
- Study dates
- 15 Dec 2018to 15 Oct 2019
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients, identified as positive or definitely positive through Frankl behavioral rating scale.
- Children, requiring local anesthesia infiltration for conservative treatment of two primary upper jaw molars bilaterally.
- Children without previous experience with local anesthesia for dental treatment.
- Obtained informed consent from parents or gave-givers to participate in the study.
Who cannot join
- Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic non-epileptic events, sensitivity to flashing light or motion.
- Vision requiring correction with eyeglasses.
- Recent injury to the eyes or face that prevents comfortable use of VR hardware or software.
- Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.
- Patients with allergy to local anesthetics of the amide group.
- Children, who are first time ever dental patients.
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Department of Pediatric Dentistry, Faculty of Dental Medicine
Plovdiv, 4000
About this study
Official title: Efficacy of Virtual Reality Distraction in Reducing Injection Pain and Anxiety During Local Anesthesia in Pediatric Dental Patients
The aim of this study is to determine the efficacy of a virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients.
The clinical trial is a randomized split-mouth assignment. Included patients are 8-12 years old requiring local anesthetic infiltration with conventional syringe (CS) for conservative treatment of two primary maxillary molars bilaterally.
Eligible patients undergo two single-visit treatments after CFSS-DS measurement before each, whereas VR is allocated to either first or second local anesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale (VAS). Secondary outcome measures: self-reported anxiety during injection on FIS; pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to local anesthesia method - CS or CS+VR.
Read the detailed description
Achieving local anesthesia in children is one of the critical aspects of pain management.
A contemporary engaging form of distraction is represented by virtual reality devices. Virtual reality (VR) devices create a virtual environment of view and sound that allow patients to be immersed in an interactive, simulated world to distract them from pain. The VR devices have a wide viewing field and three-dimensional displays that project the images right in front of the user. They not only show potentially attractive audio-visual stimuli, but also exclude all other visual environmental stimuli that may affect the patient.
The aim of this study is to determine the efficacy of a virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients.
The device used in this study is Noon VR, FXGear, compatible with a mobile phone.
The clinical trial is a randomized split-mouth assignment. Included patients are healthy positive children 8-12 years old requiring local anesthetic infiltration for conservative treatment of two primary maxillary molars bilaterally.
Eligible patients undergo two single-visit treatments after measurement of dental fear prior to each according to the Dental Subscale of the Children's Fear Survey Schedule (CFSS-DS). Local anesthetic is delivered through buccal infiltration with conventional syringe, where as the virtual reality distraction is allocated to either first or second local anesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale. Secondary outcome measures: self-reported anxiety during injection on Facial Image Scale; pain-related behavior according to Faces, Legs, Activity, Cry, Consolability (FLACC) scale; heart-rate dynamics; patient preference to local anesthesia method - traditional infiltration or virtual reality device-assisted injection.
- Conditions
- Injection Pain, Local Anesthesia
- Being tested
- Local anesthesia with conventional syringe, Local anesthesia with conventional syringe + VR device
- Keywords
- virtual reality, pain control, pediatric dental patients, pediatric pain management, local anesthesia children
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthesia with conventional syringeProcedure or surgery
Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.
Local anesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL
Local anesthesia with conventional syringe + VR deviceDevice
Virtual reality device (Noon VR, Gear FX) is placed on the face of the patient, playing a video of soothing and peaceful natural landscapes.
Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.
Local anesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Local anesthesia with conventional syringe Receives: Procedure: Local anesthesia with conventional syringe |
| Virtual reality group | Active comparator | Local anesthesia with conventional syringe + VR device Receives: Device: Local anesthesia with conventional syringe + VR device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain felt during injection using visual analogue scale
Self-reported pain by the patient immediately after local anaesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.
Measured: Immediately after local anesthetic delivery
Secondary outcomes (5)
Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale
Evaluated by the outcomes assessor. The FLACC scale has five criteria - Faces, Legs, Activity, Cry, Consolability, which are each assigned a score of 0, 1 or 2. Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain.
Measured: During local anesthesia procedure
Self-reported anxiety during injection evaluated on FIS
The Facial Image Scale (FIS) comprises a row of five faces from very unhappy (score 5) to very happy (score 1).
Measured: Immediately after local anesthetic delivery
Heart rate dynamics of the patient
Patient's left index finger is connected to a portable recording pulse oximeter for children.
Measured: Start: in the waiting room, at least 5 minutes before local anaesthesia procedure. End: at least 5 minutes after treatment.
Assessment of self-reported dental fear on CFSS-DS questionnaire
Assessment will be performed prior to both visits.
Measured: At least 5 minutes before local anesthesia
Patient preference to local anesthesia method
One week after the second dental visit, the patient is reached by a phone call and asked: "Which method do you prefer to put your tooth to sleep? With the virtual reality device or without it?"
Measured: One week after second procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start15 Dec 2018
- Primary completion10 Jun 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection PainStudies 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
- Crossover
- Model description
- Randomized Intervention Model: Split-mouth assignment
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plovdiv Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elitsa Veneva, DMD, Principal investigator, Plovdiv Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772483
- Sponsor's protocol ID
- PlovdivMU2
- Status last verified
- Jun 2021
- First submitted
- 6 Dec 2018
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Virtual Reality Distraction in Reducing Injection Pain and Anxiety During Local Anesthesia in Pediatric Dental Patients
- ClinicalTrials.gov ID
- NCT03772483
- Acronym / sponsor ID
- PlovdivMU2
- Conditions
- Injection Pain, Local Anesthesia
- Keywords
- virtual reality, pain control, pediatric dental patients, pediatric pain management, local anesthesia children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Plovdiv Medical UniversityUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 11 Dec 2018 (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 aim of this study is to determine the efficacy of a virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients.
The clinical trial is a randomized split-mouth assignment. Included patients are 8-12 years old requiring local anesthetic infiltration with conventional syringe (CS) for conservative treatment of two primary maxillary molars bilaterally.
Eligible patients undergo two single-visit treatments after CFSS-DS measurement before each, whereas VR is allocated to either first or second local anesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale (VAS). Secondary outcome measures: self-reported anxiety during injection on FIS; pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to local anesthesia method - CS or CS+VR.
Detailed description
Achieving local anesthesia in children is one of the critical aspects of pain management.
A contemporary engaging form of distraction is represented by virtual reality devices. Virtual reality (VR) devices create a virtual environment of view and sound that allow patients to be immersed in an interactive, simulated world to distract them from pain. The VR devices have a wide viewing field and three-dimensional displays that project the images right in front of the user. They not only show potentially attractive audio-visual stimuli, but also exclude all other visual environmental stimuli that may affect the patient.
The aim of this study is to determine the efficacy of a virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients.
The device used in this study is Noon VR, FXGear, compatible with a mobile phone.
The clinical trial is a randomized split-mouth assignment. Included patients are healthy positive children 8-12 years old requiring local anesthetic infiltration for conservative treatment of two primary maxillary molars bilaterally.
Eligible patients undergo two single-visit treatments after measurement of dental fear prior to each according to the Dental Subscale of the Children's Fear Survey Schedule (CFSS-DS). Local anesthetic is delivered through buccal infiltration with conventional syringe, where as the virtual reality distraction is allocated to either first or second local anesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale. Secondary outcome measures: self-reported anxiety during injection on Facial Image Scale; pain-related behavior according to Faces, Legs, Activity, Cry, Consolability (FLACC) scale; heart-rate dynamics; patient preference to local anesthesia method - traditional infiltration or virtual reality device-assisted injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Intervention Model: Split-mouth assignment
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Local anesthesia with conventional syringeLocal anesthesia with conventional syringe |
| Virtual reality group | Active comparator | Device: Local anesthesia with conventional syringe + VR deviceLocal anesthesia with conventional syringe + VR device |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients, identified as positive or definitely positive through Frankl behavioral rating scale.
- Children, requiring local anesthesia infiltration for conservative treatment of two primary upper jaw molars bilaterally.
- Children without previous experience with local anesthesia for dental treatment.
- Obtained informed consent from parents or gave-givers to participate in the study.
Key exclusion criteria (6 listed)
- Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic non-epileptic events, sensitivity to flashing light or motion.
- Vision requiring correction with eyeglasses.
- Recent injury to the eyes or face that prevents comfortable use of VR hardware or software.
- Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.
- Patients with allergy to local anesthetics of the amide group.
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 |
|---|---|---|
| Local anesthesia with conventional syringeBuccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized. Local anesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL | Procedure or surgery | Control group |
| Local anesthesia with conventional syringe + VR deviceVirtual reality device (Noon VR, Gear FX) is placed on the face of the patient, playing a video of soothing and peaceful natural landscapes. Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized. Local anesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL | Device | Virtual reality group |
Primary outcome
Pain felt during injection using visual analogue scale
Time frame: Immediately after local anesthetic delivery
Self-reported pain by the patient immediately after local anaesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.
5 secondary outcomes
Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale
Time frame: During local anesthesia procedure
Self-reported anxiety during injection evaluated on FIS
Time frame: Immediately after local anesthetic delivery
Heart rate dynamics of the patient
Time frame: Start: in the waiting room, at least 5 minutes before local anaesthesia procedure. End: at least 5 minutes after treatment.
Assessment of self-reported dental fear on CFSS-DS questionnaire
Time frame: At least 5 minutes before local anesthesia
Patient preference to local anesthesia method
Time frame: One week after second procedure
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 4 Jun 2021.
- 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.
Elitsa Veneva, DMD principal investigator
Plovdiv Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local anesthesia with conventional syringe and Local anesthesia with conventional syringe + VR device in people with Injection Pain and Local Anesthesia, run by Plovdiv Medical University at 1 site in Bulgaria.
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 4 Jun 2021. 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 Bulgaria. 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?
Pain felt during injection using visual analogue scale (time frame: Immediately after local anesthetic delivery). 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 4 Jun 2021.