Dental AnxietyNCT05083988
Effect of Virtual Reality Distraction on Anxiety and Pain Reduction in Children Undergoing Dental Treatment
A study testing virtual reality glasses and music in people with Dental Anxiety, run by Cairo University.
Trial summary
The aim of the study is to evaluate and compare the effect of virtual reality glasses (VR) as an audiovisual distraction method to audio distraction using music on child's dental anxiety during dental treatment. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- virtual reality glasses and music
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Dec 2022
- 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 5-8 years.
- Children without any mental or systemic disorder.
- Children need extraction of primary molars under local anesthesia.
Who cannot join
- Children with visual impairment.
- Children with hearing disabilities.
- Patients or caregivers who refuse to sign the consent.
Trial locations and contacts
No sites are listed yet.
omneya Ahmed Abdelrazik, B.D.S Cairo university contact
About this study
Official title: Effect of Virtual Reality Distraction Versus Audio Distraction on Anxiety and Pain Reduction in Children Undergoing Dental Treatment (A Randomized Clinical Trial)
The aim of the study is to evaluate and compare the effect of virtual reality glasses (VR) as an audiovisual distraction method to audio distraction using music on child's dental anxiety during dental treatment.
Read the detailed description
a randomized clinical trial with parallel-group and allocation ratio (1:1). intervention group: audiovisual distraction using virtual reality glasses control group :audio distraction using music. in children aged 5-8 years who need dental extraction for primary molars.
For both groups:
- Taking personal data, medical and dental history.
- Diagnosis and determination of the required treatment.
- Measuring preoperative anxiety (expressed by heart rate) using a pulse oximeter.
- Using the behavior guidance technique: Intervention group: The Child is introduced to the virtual reality glasses device, and was given instructions on how to use it and was allowed to choose one of previously chosen cartoons to be played during the procedure. Control group: The child is introduced to the headphones and was given instructions on how to use it, and a relaxing music is played during the procedure.
- Administration of topical anesthesia.
- Administration of local anesthesia.
- Check the effectiveness of local anesthesia using dental probe.
- Extraction of the affected tooth.
- Measuring postoperative anxiety (expressed by heart rate) using the pulse oximeter.
- Evaluate the objective pain using Face, Legs, Cry, Consolabiliy scale .
- Self-reporting of subjective pain using Visual analogue scale.
- Post extraction instructions are given to the patient.
- Conditions
- Dental Anxiety
- Being tested
- virtual reality glasses, music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality glassesDevice
Also called audiovisual distraction
a system composed of a head-mounted wide view display placed in front of the eyes and headphones placed in ears, it has the ability to block the real-world stimuli. This could distract the patient from the dental environment, which helps reduce anxiety
musicDevice
Also called audiodistraction
Music can be used to distract patients from the anxiety provoking stimulus. It helps the patient to escape from the stressful reality as it activates imaginary. Psychosocially music can offer peace and comfort to patients during dental treatment as it helps in making the environment less threatening.
| Study group | Role | What they receive |
|---|---|---|
| audiovisual distraction | Experimental | Not described Receives: Device: virtual reality glasses |
| audiodistraction | Experimental | Not described Receives: Device: music |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative anxiety
Preoperative anxiety will be measured before administration of local anesthesia using a fingertip pulse oximeter in beat per minute unit (BPM)
Measured: before administration of local anesthesia
postoperative anxiety
using a fingertip pulse oximeter in beat per minute unit (BPM)
Measured: immediately after dental extraction
preoperative anxiety
RMS-pectorial scale ( Raghavendra, Madhuri, Sujata - pectorial scale) before administration of local anesthesia in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety
Measured: before administration of local anesthesia
postoperative anxiety
S-pectorial scale ( Raghavendra, Madhuri, Sujata - pectorial scale) immediatly after extraction in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety
Measured: immediately after dental extraction
Secondary outcomes (2)
subjective pain
using Visual analogue scale (vas scale) (0-10) , self reported pain as the child choose a number from 0 to 10 which describes the intensity of his or her pain.
0 =no pain 10=extreme pain.
Measured: immediately after extraction.
objective pain
using FLCCS (0-10)valuated 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 dental extraction procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study startJun 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel-group and allocation ratio (1:1) Intervention: virtual reality glasses. Control: audiodistraction using music
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omneya Ahmed AbdelRazik saleh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083988
- Sponsor's protocol ID
- Dental anxiety reduction
- Status last verified
- May 2022
- First submitted
- 6 Oct 2021
- Last updated
- 12 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
CustOdio NB, Cademartori MG, Azevedo MS, Mendes MA, Schardozim LR, Costa LRRSD, Goettems ML. Efficacy of audiovisual distraction using eyeglasses during dental care: a randomized clinical trial. Braz Oral Res. 2021 Feb 12;35:e26. doi: 10.1590/1807-3107bor-2021.vol35.0026. eCollection 2021.
PubMed 33605356Packyanathan JS, Lakshmanan R, Jayashri P. Effect of music therapy on anxiety levels on patient undergoing dental extractions. J Family Med Prim Care. 2019 Dec 10;8(12):3854-3860. doi: 10.4103/jfmpc.jfmpc_789_19. eCollection 2019 Dec.
PubMed 31879625Felemban OM, Alshamrani RM, Aljeddawi DH, Bagher SM. Effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients: a randomized clinical trial. BMC Oral Health. 2021 Jun 25;21(1):321. doi: 10.1186/s12903-021-01678-x.
PubMed 34172032Nunna M, Dasaraju RK, Kamatham R, Mallineni SK, Nuvvula S. Comparative evaluation of virtual reality distraction and counter-stimulation on dental anxiety and pain perception in children. J Dent Anesth Pain Med. 2019 Oct;19(5):277-288. doi: 10.17245/jdapm.2019.19.5.277. Epub 2019 Oct 30.
PubMed 31723668Scheerman JFM, van Meijel B, van Empelen P, Kramer GJC, Verrips GHW, Pakpour AH, Van den Braak MCT, van Loveren C. Study protocol of a randomized controlled trial to test the effect of a smartphone application on oral-health behavior and oral hygiene in adolescents with fixed orthodontic appliances. BMC Oral Health. 2018 Feb 7;18(1):19. doi: 10.1186/s12903-018-0475-9.
PubMed 29415697Grisolia BM, Dos Santos APP, Dhyppolito IM, Buchanan H, Hill K, Oliveira BH. Prevalence of dental anxiety in children and adolescents globally: A systematic review with meta-analyses. Int J Paediatr Dent. 2021 Mar;31(2):168-183. doi: 10.1111/ipd.12712. Epub 2020 Sep 9.
PubMed 33245591Dahlander A, Soares F, Grindefjord M, Dahllof G. Factors Associated with Dental Fear and Anxiety in Children Aged 7 to 9 Years. Dent J (Basel). 2019 Jul 1;7(3):68. doi: 10.3390/dj7030068.
PubMed 31266156Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939.
PubMed 32694387Lopez-Valverde N, Muriel Fernandez J, Lopez-Valverde A, Valero Juan LF, Ramirez JM, Flores Fraile J, Herrero Payo J, Blanco Antona LA, Macedo de Sousa B, Bravo M. Use of Virtual Reality for the Management of Anxiety and Pain in Dental Treatments: Systematic Review and Meta-Analysis. J Clin Med. 2020 Apr 5;9(4):1025. doi: 10.3390/jcm9041025.
PubMed 32260538Sivakumar P, Gurunathan D. Behavior of Children toward Various Dental Procedures. Int J Clin Pediatr Dent. 2019 Sep-Oct;12(5):379-384. doi: 10.5005/jp-journals-10005-1670.
PubMed 32440041
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Distraction Versus Audio Distraction on Anxiety and Pain Reduction in Children Undergoing Dental Treatment (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05083988
- Acronym / sponsor ID
- Dental anxiety reduction
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 19 Oct 2021 (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 the study is to evaluate and compare the effect of virtual reality glasses (VR) as an audiovisual distraction method to audio distraction using music on child's dental anxiety during dental treatment.
Detailed description
a randomized clinical trial with parallel-group and allocation ratio (1:1). intervention group: audiovisual distraction using virtual reality glasses control group :audio distraction using music. in children aged 5-8 years who need dental extraction for primary molars.
For both groups:
- Taking personal data, medical and dental history.
- Diagnosis and determination of the required treatment.
- Measuring preoperative anxiety (expressed by heart rate) using a pulse oximeter.
- Using the behavior guidance technique: Intervention group: The Child is introduced to the virtual reality glasses device, and was given instructions on how to use it and was allowed to choose one of previously chosen cartoons to be played during the procedure. Control group: The child is introduced to the headphones and was given instructions on how to use it, and a relaxing music is played during the procedure.
- Administration of topical anesthesia.
- Administration of local anesthesia.
- Check the effectiveness of local anesthesia using dental probe.
- Extraction of the affected tooth.
- Measuring postoperative anxiety (expressed by heart rate) using the pulse oximeter.
- Evaluate the objective pain using Face, Legs, Cry, Consolabiliy scale .
- Self-reporting of subjective pain using Visual analogue scale.
- Post extraction instructions are given to the patient.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parallel-group and allocation ratio (1:1) Intervention: virtual reality glasses. Control: audiodistraction using music
| Arm | Type | Receives |
|---|---|---|
| audiovisual distraction | Experimental | Device: virtual reality glasses |
| audiodistraction | Experimental | Device: music |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 5-8 years.
- Children without any mental or systemic disorder.
- Children need extraction of primary molars under local anesthesia.
Key exclusion criteria (3 listed)
- Children with visual impairment.
- Children with hearing disabilities.
- Patients or caregivers who refuse to sign the consent.
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 glassesAlso: audiovisual distractiona system composed of a head-mounted wide view display placed in front of the eyes and headphones placed in ears, it has the ability to block the real-world stimuli. This could distract the patient from the dental environment, which helps reduce anxiety | Device | audiovisual distraction |
| musicAlso: audiodistractionMusic can be used to distract patients from the anxiety provoking stimulus. It helps the patient to escape from the stressful reality as it activates imaginary. Psychosocially music can offer peace and comfort to patients during dental treatment as it helps in making the environment less threatening. | Device | audiodistraction |
Primary outcome
preoperative anxiety
Time frame: before administration of local anesthesia
Preoperative anxiety will be measured before administration of local anesthesia using a fingertip pulse oximeter in beat per minute unit (BPM)
postoperative anxiety
Time frame: immediately after dental extraction
using a fingertip pulse oximeter in beat per minute unit (BPM)
preoperative anxiety
Time frame: before administration of local anesthesia
RMS-pectorial scale ( Raghavendra, Madhuri, Sujata - pectorial scale) before administration of local anesthesia in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety
postoperative anxiety
Time frame: immediately after dental extraction
S-pectorial scale ( Raghavendra, Madhuri, Sujata - pectorial scale) immediatly after extraction in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety
2 secondary outcomes
subjective pain
Time frame: immediately after extraction.
objective pain
Time frame: during dental extraction procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Results publication: PubMed 33605356CustOdio NB, Cademartori MG, Azevedo MS, Mendes MA, Schardozim LR, Costa LRRSD, Goettems ML. Efficacy of audiovisual distraction using eyeglasses during dental care: a randomized clinical trial. Braz Oral Res. 2021 Feb 12;35:e26. doi: 10.1590/1807-3107bor-2021.vol35.0026. eCollection 2021.
- Results publication: PubMed 31879625Packyanathan JS, Lakshmanan R, Jayashri P. Effect of music therapy on anxiety levels on patient undergoing dental extractions. J Family Med Prim Care. 2019 Dec 10;8(12):3854-3860. doi: 10.4103/jfmpc.jfmpc_789_19. eCollection 2019 Dec.
- Results publication: PubMed 34172032Felemban OM, Alshamrani RM, Aljeddawi DH, Bagher SM. Effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients: a randomized clinical trial. BMC Oral Health. 2021 Jun 25;21(1):321. doi: 10.1186/s12903-021-01678-x.
- Results publication: PubMed 31723668Nunna M, Dasaraju RK, Kamatham R, Mallineni SK, Nuvvula S. Comparative evaluation of virtual reality distraction and counter-stimulation on dental anxiety and pain perception in children. J Dent Anesth Pain Med. 2019 Oct;19(5):277-288. doi: 10.17245/jdapm.2019.19.5.277. Epub 2019 Oct 30.
- Results publication: PubMed 29415697Scheerman JFM, van Meijel B, van Empelen P, Kramer GJC, Verrips GHW, Pakpour AH, Van den Braak MCT, van Loveren C. Study protocol of a randomized controlled trial to test the effect of a smartphone application on oral-health behavior and oral hygiene in adolescents with fixed orthodontic appliances. BMC Oral Health. 2018 Feb 7;18(1):19. doi: 10.1186/s12903-018-0475-9.
- Results publication: PubMed 33245591Grisolia BM, Dos Santos APP, Dhyppolito IM, Buchanan H, Hill K, Oliveira BH. Prevalence of dental anxiety in children and adolescents globally: A systematic review with meta-analyses. Int J Paediatr Dent. 2021 Mar;31(2):168-183. doi: 10.1111/ipd.12712. Epub 2020 Sep 9.
- Results publication: PubMed 31266156Dahlander A, Soares F, Grindefjord M, Dahllof G. Factors Associated with Dental Fear and Anxiety in Children Aged 7 to 9 Years. Dent J (Basel). 2019 Jul 1;7(3):68. doi: 10.3390/dj7030068.
- Results publication: PubMed 32694387Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939.
- Results publication: PubMed 32260538Lopez-Valverde N, Muriel Fernandez J, Lopez-Valverde A, Valero Juan LF, Ramirez JM, Flores Fraile J, Herrero Payo J, Blanco Antona LA, Macedo de Sousa B, Bravo M. Use of Virtual Reality for the Management of Anxiety and Pain in Dental Treatments: Systematic Review and Meta-Analysis. J Clin Med. 2020 Apr 5;9(4):1025. doi: 10.3390/jcm9041025.
- Results publication: PubMed 32440041Sivakumar P, Gurunathan D. Behavior of Children toward Various Dental Procedures. Int J Clin Pediatr Dent. 2019 Sep-Oct;12(5):379-384. doi: 10.5005/jp-journals-10005-1670.
- 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.
omneya Ahmed Abdelrazik, B.D.S Cairo university contact
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality glasses and music in people with Dental Anxiety, run by Cairo University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact omneya Ahmed Abdelrazik, B.D.S Cairo university (00201016300046, omneya.saleh@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preoperative anxiety (time frame: before administration of local anesthesia). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05083988, which also lists 10 linked publications.
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 12 May 2022.